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Abstract

Purpose of review: The purpose of this study is to review the current evidence on the relationship between diet and heart, giving practical recommendations for cardiovascular prevention. Recent findings: A heart-healthy diet should maximize the consumption of whole grains, vegetables, fruit, and legumes and discourage the consumption of meat and meat products as well as refined and processed foods. Plant-based diets fully meet these criteria, and the evidence supporting the protective effect of these dietary patterns evolved rapidly in recent years. Among plant-based diets, the Mediterranean and vegetarian diets gained the greater interest, having been associated with numerous health benefits such as reduced levels of traditional and novel risk factors and lower risk of cardiovascular disease. These positive effects may be explained by their high content of dietary fiber, complex carbohydrate, vitamins, minerals, polyunsaturated fatty acids, and phytochemicals. Current evidence suggests that both Mediterranean and vegetarian diets are consistently beneficial with respect to cardiovascular disease.
LIPID ABNORMALITIES AND CARDIOVASCULAR PREVENTION (G DE BACKER, SECTION EDITOR)
A Heart-Healthy Diet: Recent Insights
and Practical Recommendations
Monica Dinu
1
&Giuditta Pagliai
1
&Francesco Sofi
1,2,3
#Springer Science+Business Media, LLC 2017
Abstract
Purpose of Review The purpose of this study is to review the
current evidence on the relationship between diet and heart,
giving practical recommendations for cardiovascular
prevention.
Recent Findings A heart-healthy diet should maximize the
consumption of whole grains, vegetables, fruit, and legumes
and discourage the consumption of meat and meat products as
well as refined and processed foods. Plant-based diets fully
meet these criteria, and the evidence supporting the protective
effect of these dietary patterns evolved rapidly in recent years.
Among plant-based diets, the Mediterranean and vegetarian
diets gained the greater interest, having been associated with
numerous health benefits such as reduced levels of traditional
and novel riskfactors and lower risk of cardiovascular disease.
These positive effects may be explained by their high content
of dietary fiber, complex carbohydrate, vitamins, minerals,
polyunsaturated fatty acids, and phytochemicals.
Summary Current evidence suggests that both Mediterranean
and vegetarian diets are consistently beneficial with respect to
cardiovascular disease.
Keywords Diet .Heart .Mediterranean diet .Vegetarian
diet .Cardiovascular disease
Abbreviations
AHS Adventist Health Study
AMS Adventist Mortality Study
BMI Body mass index
DHA Docosahexaenoic acid
EPA Eicosapentaenoic acid
EPIC European Prospective Investigation into Cancer
and Nutrition
HDL High-density lipoprotein
HFSS Health Food Shopper Study
LDL Low-density lipoprotein
NHANES National Health and Nutrition Examination
Survey
OVS Oxford Vegetarian Study
WHO World Health Organization
Introduction
The relationship between dietary factors and cardiovascular
disease has been a major issue of research for decades, since
the first results of the pioneering Seven CountriesStudy
conducted by Ancel Keys have been released [1]. The reduced
prevalence of cardiovascular disease reported by the
Mediterranean countries during this study stimulated the clin-
ical research to evaluate the possible association between diet
and dietary habits and main chronic degenerative diseases.
A vast abundance of literature demonstrates that both inci-
dence and mortality from cardiovascular disease can be easily
prevented with adequate dietary choices and correctlifestyles,
such as moderate physical activity, abstinence from tobacco
smoking, and from harmful use of alcohol [2]. A balanced
diet, in terms of both quantity and quality, represents a key
factor for the optimal prevention of cardiovascular disease, by
reducing the risk of occurrence of the first ischemic event and
This article is part of the Topical Collection on Lipid Abnormalities and
Cardiovascular Prevention
*Francesco Sofi
francesco.sofi@unifi.it
1
Department of Experimental and Clinical Medicine, University of
Florence, Largo Brambilla 3, 50134 Florence, Italy
2
Clinical Nutrition Unit, Careggi University Hospital, Florence, Italy
3
Don Carlo Gnocchi Foundation Italy, Onlus IRCCS, Florence, Italy
Curr Cardiol Rep (2017) 19:95
DOI 10.1007/s11886-017-0908-0
improving the prognosis after the first event [3]. In the last few
decades, several dietary patterns have attracted public atten-
tion, but those that got the most interest were two plant-based
diets such as Mediterranean diet and the vegetarian diets.
Indeed, these dietary profiles have a common background
since they are both aimed at maximizing the consumption of
whole, plant-based foods and discouraging consumption of
meat and meat products as well as refined and processed
foods. Being rich in dietary fiber, complex carbohydrate, vi-
tamins, minerals, polyunsaturated fatty acids and phytochem-
icals, plant-based diets represent a useful instrument for
preventing heart disease [4].
Recent meta-analyses conducted in the last years showed a
consistent reduced risk of occurrence of cardiovascular dis-
ease for both Mediterranean and vegetarian diets [5••,6]. The
aim of this review was to examine the scientific evidence on
the beneficial effects of these two diets on heart health, giving
practical and evidence-based recommendations for cardiovas-
cular disease prevention.
Mediterranean Diet
The Mediterranean diet is considered one of the healthiest
dietary patterns for preventing diseases and maintaining the
health status, as several studies have shown that greater ad-
herence to a Mediterranean-like dietary pattern is associated
with a significant reduced risk of occurrence for chronic de-
generative diseases [7••]. The Mediterranean diet is a typical
dietary pattern traditionally followed by the people living in
the countries bordering the Mediterranean Sea. The main
characteristics of this dietary pattern include a high consump-
tion of vegetables, fruits, whole grains, legumes, nuts and
seeds and olive oil, fish, dairy products, poultry, and eggs
consumed in low-to-moderate amounts, and low intake of
red meat with a regular but moderate consumption of ethanol
(mainly as red wine). Although it is not clear which compo-
nents of the diet provide the greatest health benefits, it is
likely that certain components, when consumed collectively,
provide a protection versus chronic diseases [8].
Numerous prospective cohort studies and some clinical
trials are exponentially increasing the level and the quality of
the scientific evidence on the Mediterranean diet. Subjects in
the highest quantile of adherence to the Mediterranean diet
had a 24% lower incidence and mortality from cardiovascular
disease compared to those least adherent [6]. A significant
reduction of risk was also found for stroke (24%), myocar-
dial infarction (33%), and coronary heart disease (28%) [6].
A recent umbrella review summarizing the evidence available
from all the published meta-analysis that studied the adher-
ence to the Mediterranean diet and different health outcomes
demonstrated the existence of a robust evidence on the rela-
tionship between a greater adherence to this dietary pattern
and cardiovascular outcomes [7••]. In fact, a reduced risk for
cardiovascular disease incidence and mortality, myocardial
infarction, and coronary heart disease was evidenced in both
meta-analyses of prospective cohort studies and intervention
studies [7••]. This positive effect is likely related to greater
effectiveness of the Mediterranean diet in lowering main car-
diovascular risk factors such as body mass index, lipid, and
glycemic profile, as well as inflammatory parameters when
compared with other diets. Regarding lipid profile, several
meta-analyses and intervention studies demonstrated a bene-
ficial effect of a Mediterranean diet on lipid variables, includ-
ing total and low-density lipoprotein (LDL)-cholesterol [7••].
In addition, a recent study reported that, even though the
Mediterranean diet was not able to raise high-density lipopro-
tein (HDL) levels, it enhanced the cardio protective capacity
of HDL cholesterol by improving HDL oxidative status and
composition [9]. Suggestive evidence also supports an effect
on improving glycaemic control and insulin sensitivity in peo-
ple following a Mediterranean diet [7••]. Insulin resistance
and diabetes, which are independent risk factors for cardio-
vascular disease, are linked to sugars and saturated fatty acids
consumption, excess energy intake and increased adiposity
[10]. Moreover, recent findings on the beneficial effects of
the Mediterranean on inflammatory parameters have been ob-
tained [11]. Inflammation has a key role at all the stages of the
cardiovascular disease and is crucial in the development and
rupture of the atheromatous plaque. Mediterranean diet has
been found to determine a significant reduction of circulating
levels of C-reactive protein, interleukin-6, and cell adhesion
molecules, determining a downregulation of cellular and hu-
moral inflammatory pathways related to atherosclerosis [12].
Vegetarian Diets
Over the last decades, the growing evidence about the rela-
tionship between consumption of animal productsand the risk
of chronic diseases has determined a greater interest in the
vegetarian diets. The number of people who, in recent years,
began to follow a food profile characterized by the absence of
animal flesh such as meat and fish, has progressively and
continuously increased, especially among industrialized coun-
tries [13].
The positive effect of the vegetarian diet on heart health is
mainly due to a greater variety and amount of plant foods.
Abundant consumption of vegetable, fruit, legumes, unrefined
cereals, and nuts, essential components of the vegetarian die-
tary pattern, has consistently been associated with a lower risk
of cardiovascular disease [14••]. The complex mixture of phy-
tochemicals, highly present in this diet, possess potent antiox-
idant activity and show synergistic and additive effects [14••].
Furthermore, compared to omnivores, vegetarians tend to
have lower BMI, lower total and LDL-cholesterol levels,
95 Page 2 of 7 Curr Cardiol Rep (2017) 19:95
lower blood pressure, improved glycaemic control, and in-
creased insulin sensitivity [5••]. Because obesity and
dyslipidaemia are significant risk factors for heart disease,
the lower BMI and the lower intake of cholesterol in vegetar-
ians may be a significant protective factor for lowering blood
lipids and reducing the risk of cardiovascular disease.
Although the number of studies that investigate the effects
of a vegetarian diet on health is increasing, the amount of
evidence is still limited with respect to the evidence for the
Mediterranean diet. To the best of our knowledge, seven pro-
spective cohort studies evaluated the relationship between the
vegetarian diet and cardiovascular health so far. Overall, the
studies included almost 240,000 participants, half of which
were vegetarians at the time of the evaluation.
The first study, established in 1960, was the AMS that
recruited 27,529 members of the Seventh-day Adventist
church in California [15]. Seventh-day Adventists have been
increasingly subject to epidemiological studies since they
tend to be more homogenous in many aspects of lifestyle
and more heterogeneous in eating habits than the general
population. Adventists have a lower risk of chronic diseases
than the general population, and many researchers hypothe-
size that this is due to their diet and lifestyle habits [16]. In
fact, in addition to the high prevalence of vegetarianism,
such populations generally present low rates of smoking,
consume little amount of alcohol, and possibly have a high
level of physical activity. In this study, after 5.6 years of
follow-up, the death rate ratios for heart disease and for
cerebrovascular disease were significantly lower in vegetar-
ians compared with the regular meat eaters [15].
Other two studies on Adventists, the AHS-1 and the AHS-
2, involving 34,000 and 96,000 subjects respectively, were
conducted over the last 40 years [17,18]. In the AHS-1, veg-
etarians showed a lower mortality rate for heart disease
(38%) when compared to omnivores. Contrariwise, in omni-
vores, a greater incidence of obesity, hypertension, and type 2
diabetes mellitus has been observed [17]. The AHS-2, which
started in 2002, is still in progress. Preliminary data show that
vegetarians tend to have less cardiovascular risk factors (i.e.,
lower BMI, lower cholesterol and blood glucose levels, and a
lower prevalence of hypertension, overweight and obesity,
type 2 diabetes mellitus, and metabolic syndrome). In men, a
29% significant reduction of cardiovascular events has been
observed [18].
While Adventist cohorts suggested a potential relationship
between the vegetarian diet and the reduction of cardiovascu-
lar disease, the other cohorts demonstrated a modest effect.
For example, the HFSS highlighted not significant differences
in heart disease and cerebrovascular disease between British
vegetarians and omnivores [19]. Similar results were observed
in the Heidelberg Study, a German prospective study that has
followed for 21 yearsfrom 1984 to 2005a total of 1225
vegetarians and 679 health-consciousomnivores. The
overall mortality rate for heart disease between the two groups
did not show significant differences, but it was reduced com-
pared to the general population [20].
The OVS, a prospective study conducted on 11,040 British
participants recruited between 1980 and 1984, found lower
BMI and lower levels of total and LDL-cholesterol in vege-
tarians, but significant differences between vegetarians and
omnivores have not been highlighted in terms of cardiovascu-
lar outcomes [19]. Finally, the Oxford component of the EPIC
study monitored 65,000 men and women living in the UK,
recruited between 1993 and 1999 through collaboration with
family physicians and through the postal service. After
11.6 years of follow-up, vegetarians had a 32% lower risk of
heart disease than omnivores. This result was only slightly
attenuated after adjustment for BMI and did not differ by
sex, age, BMI, smoking, or the presence of cardiovascular risk
factors [21]. According to the authors, the risk difference was
probably mediated through the effect of the vegetarian diet on
cholesterol levels and blood pressure. However, a recent study
that analyzed pooled mortality data from the EPIC-Oxford
cohort and the OVS found no difference in mortality from
cardiovascular and cerebrovascular diseases between vegetar-
ians and omnivores [22].
A recent meta-analysis conducted by our group confirmed
a protective effect of the vegetarian diet versus cardiovascular
diseases in a population of over 65,000 vegetarians [5••]. A
significant 25% reduced risk of ischemic heart disease was
obtained, most probably determined by the reduction of main
traditional cardiovascular risk factors, including BMI, lipid
variables, and glucose levels [5••].
Practical Recommendations for a Heart-Healthy
Diet
Despite the spread of information on diet and dietary habits,
progressive change in eating habits has been observed in re-
cent years with a progressive worsening of nutritional quality
in terms of prevention [23]. Therefore, the main scientific
associations have indicated some major recommendations to
follow a healthy diet, especially for preventing cardiovascular
diseases.
&Reduce the calories. Given the importance of obesity and
overweight in the pathogenesis of cardiovascular disease,
avoiding excessive calorie consumption is of paramount
importance. Since calories consumed with beverages are
less visible than calories from solid foods, limiting bever-
age consumption is particularly important [24].
&Increase the consumption of fruit and vegetables (at least
five servings per day). A high consumption of fruits and
vegetables is associated with a reduction in the risk of
cardiovascular diseases as well as many of the most
Curr Cardiol Rep (2017) 19:95 Page 3 of 7 95
important neoplasms [25]. In addition, fruits and vegeta-
bles represent the main source of fiber and an important
source of vitamins, especially the B group and antioxi-
dants. In randomized controlled trials, fruit and vegetable
consumption has shown substantial improvements in var-
ious risk factors such as blood pressure, plasma lipid
levels, pro-inflammatory parameters, endothelial function,
weight control, and circulating insulin levels [26]. The
benefits do not appear to be reproducible with equivalent
amounts of minerals, vitamins, and with fiber supple-
ments, nor are dependent on the composition of macronu-
trients in the diet [27]. This evidence suggests that the
benefits could be derived from a more complex set of
micronutrients, phytochemicals, and fibers present in
fruits and vegetables and not in multivitamin preparations,
greater bioavailability of these substances in their natural
state, and substitution of less foods healthy in the diet [27].
In long-term observational studies, the consumption of
200 g/day of fruit and vegetables has been associated with
lower incidence of coronary heart disease (8%), stroke
(16%), and cardiovascular disease (8%) [25].
&Increase the consumption of legumes. Eating legumes as
part of a healthy diet may help improving blood choles-
terol, a leading cause of cardiovascular disease [28], as
well as body weight [29]. Legumes are the best source
of vegetable protein and contain minerals and fiber. High
plant protein intake was inversely associated with cardio-
vascular mortality, especially in subjects with at least one
unhealthy lifestyle factor [30]. Results from the NHANES
study clearly showed that legumesconsumption 4times
a week is associated with an 11% lower risk of cardiovas-
cular disease and a 22% reduced risk of coronary heart
disease compared to once per week [31]. A recent meta-
analysis reported a 14% reduction of ischemic heart dis-
ease risk for a consumption of legumes that reach four
portions (100 g/serving) per week [32].
&Increase the consumption of whole grain products.The
consumption of whole grain cereals with high fiber con-
tent has a double benefit on health. First, fiber consump-
tion from cereal products is associated with lower risk of
cardiovascular risk factors and heart disease [33,34].
Secondly, increased dietary fiber consumption reduces
the risk of developing type 2 diabetes, facilitates weight
control, and helps prevent constipation [35]. Whole grains
are foods that include bran, germ, and endosperm of nat-
ural cereal. Such composite products contain soluble and
insoluble food fibers, group B vitamins, minerals, flavo-
noids, and tocopherols, as well as numerous fatty acids,
antioxidants, and phytochemicals. In randomized clinical
trials, it has been demonstrated that whole grain consump-
tion improves insulin resistance and endothelial function
and reduces inflammatory parameters [36]. Whole grain
consumption reduces LDL-cholesterol, without reducing
HDL cholesterol or triggering triglycerides [37].
Consistently with the physiological benefits, a greater
consumption of whole grains is associated with a lower
incidence of cardiovascular disease, coronary heart dis-
ease and diabetes mellitus [38].
&Reduce the consumption of fresh and processed meat.
Diets rich in meat and derivatives have been associated
with an increased risk of developing cardiovascular dis-
ease and stroke [39,40]. This association, particularly
strong for processed red meat, may be explained by the
harmful effect of several compounds in meat, such as so-
dium, nitrates, heme iron, as well as saturated fat and
dietary cholesterol [41••]. As current evidence suggests
that each serving per day (50 g)of processed meat increase
the cardiovascular mortality by 24%, it would be prudent
to minimize or avoid processed meats such as sausage,
salami, bacon, and low-fat deli-meats (1 or less serving/
week) and consume small amounts of unprocessed red
meat (1 serving/week) [42]. Relatively few studies have
been focused on poultry as a risk factor for cardiovascular
disease, showing mixed results [42]. In the context of a
balanced diet, poultry consumption should be limited to
23servings/week.
&Replace saturated and trans fats with unsaturated fats.
The relationship between different types of dietary fats
and risk of cardiovascular disease has been extensively
evaluated inepidemiological studies and randomized clin-
ical trials. Although recent meta-analyses did not find a
significant relationship between higher saturated fat intake
and risk of cardiovascular disease in a large population
[43,44], available evidence puts a great emphasis on the
replacement of saturated fats with unsaturated fats [2,45].
Consistent and strong evidence from randomized con-
trolled trials and prospective cohort studies shows that
replacing saturated fatty acid with unsaturated fats signif-
icantly reduce total and LDL-cholesterol, as well as the
risk of cardiovascular disease and coronary mortality [2,
45]. For every 1% of energy intake from saturated fats
replaced with unsaturated fats, incidence of coronary heart
disease is reduced by 23% [2]. Therefore, animal fats
(e.g., lard, butter, cream, beef tallow) or tropical oils
(e.g., coconut and palm oils) should be replaced by non-
hydrogenated vegetable oils and nuts. The positive effect
of this replacement may derive not only from the reduc-
tion of intake of saturated fatty acids, but also from the
widely reported beneficial associated with the consump-
tion of nuts and olive oil. In fact, a recent meta-analysis of
prospective studies supports inverse associations between
eating nuts (28 g/day) and incident coronary heart disease,
stroke, and cardiovascular disease [46]. Similar results
were observed in the largest Mediterranean diet trial,
where a Mediterranean diet plus extra virgin olive oil or
nuts determined an approximately 30% decrease in risk of
95 Page 4 of 7 Curr Cardiol Rep (2017) 19:95
major cardiovascular events [47]. On the other hand, trans
fatty acids produced by partial hydrogenation of vegetable
oils that have been used to make some commercially pre-
pared baked goods, fried foods, snack foods, or margarine
have adverse effects on cardiovascular health and should
be avoided [44].
&Increase food sources of omega-3 fatty acids. Being es-
sential fatty acids that cannot be synthesized by humans,
tissue levels of omega-3 are heavily influenced by diet.
Primary sources of omega-3 fatty acids in the form of
alpha-linolenic acid are flaxseeds, walnuts, chia seeds, ca-
nola, and soybean oils [2]. Fish, seafood, and fish oil rep-
resent the primarily source of EPA and DHA, very long
chain omega-3 fatty acids that are also synthesized in low
(5%) amount from their plant precursor, the alpha-
linolenic acid [48]. The content of EPA and DHA varies
considerably from fish to fish: fish such as anchovies,
herring, wild salmon, sardines, trout, and white tuna tend
to have higher concentrations. In order to improve their
omega-3 nutritional status, subjects following avegetarian
diet should regularly consume good sources of alpha-
linolenic acid and limit the intake of linoleic acid, as high
intakes of linoleic acid may suppress alpha-linolenic acid
conversionto EPA and DHA [49]. In human experiments,
fish oil is able to lower triglyceride levels, systolic and
diastolic blood pressure, and resting heart rate [50].
Observational evidence and randomized clinical trials
suggest that fish oil or fish consumption can reduce in-
flammation, improve endothelial function, normalize
heart rate variability, improve myocardial relaxation and
efficiency, and, at high doses, platelet aggregation [48].
Consistent with these physiological benefits, habitual con-
sumption of fish is associated with a lower incidence of
coronary heart disease and ischemic stroke, particularly
heart failure [48]. In fact, the consumption of 250 mg/d
of EPA and DHA from fish is associated with a 36%
reduction in mortality for cardiovascular disease [48].
Overall, these results are consistent with observational ob-
servations of long-term follow-up cohorts about fish in-
take 23 times/week.
&Limit the consumption of added sugar and sugar-
sweetened beverages. Sugar has no nutritional value ex-
cept for calorie intake and thus has negative health impli-
cations for people at risk of overweight. Added sugar and
sugar-sweetened beverages contribute to increase the
cardio-metabolic risk including weight gain, diabetes,
and metabolic syndrome, as well as cardiovascular disease
outcomes [51]. The 2015 Dietary Guidelines Advisory
Committee suggests the maximum restriction of added
sugars and sweetened beverages [2], while the WHO rec-
ommends a maximum limit of 10% of energy from free
sugar [52]. A further reduction to < 5% per day would
provide additional benefits.
&Limit sodium intake. The main justification for sodium
limitation is its effect on systolic blood pressure, an im-
portant risk factor for cardiovascular events and death
[53]. The WHO suggests a maximum limit of 2 g of sodi-
um per day (5 g of salt per day) [54], while average habit-
ual consumption in Western countries is currently about
double. A recent meta-analysis of cohorts prospective
studies revealed a significant relationship between higher
sodium intake and cardiovascular disease. For every in-
crease of 10 mmol/d in sodium intake, cardiovascular dis-
ease mortality increased significantly by 1% [55].
Conclusions
The identification of the best heart-healthy diet is still a chal-
lenging and highly relevant preventive health issue. A large
body of literature has evaluated associations between dietary
exposures and cardiovascular disease. Evidence-based
healthy dietary patterns are high in fruits, vegetables, whole
grains, legumes, and nuts in moderation, although some may
include limited quantities oflean meats (including poultry and
seafood), low-fat dairy products, and liquid vegetable oils.
These dietary patterns are also low in saturated, trans, and
solid fats, sodium, added sugars, and refined grains. These
characteristics are shared by both the Mediterranean and veg-
etarian diets.
Compliance with Ethical Standards
Conflict of Interest Monica Dinu, Giuditta Pagliai, and Francesco Sofi
declare that they have no conflict of interest.
Human and Animal Rights and Informed Consent This article does
not contain any studies with human or animal subjects performed by any
of the authors.
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Curr Cardiol Rep (2017) 19:95 Page 7 of 7 95
... Lipids are an essential part of the macronutrients needed in our daily diet; however, saturated and trans-fatty acids hold a notorious reputation for contributing to cardiovascular disease when consumed excessively [1]. Moreover, socioeconomic changes due to expeditious living standards have altered dietary patterns, causing an increase in saturated fats consumption, which in developing countries is the leading cause of adults mortality [2]. ...
... Consequently, high cholesterol, stroke, coronary and vascular disease are high risks to morbidity and mortality [6]. Many scholars and scientific associations have recommended changing eating habits to prevent cardiovascular disease, including the idea that the Mediterranean and plant-based diets are lower in saturated, trans and solid fats [1]. ...
... Vegetarian and vegan diets are rising for several reasons, including improved overall health [5,9,10]. The vegetarian diet, consisting of abstaining from animal products, has been linked to a positive health outcome [5], including reduced BMI and risk of cardiovascular diseases, such as stroke, myocardial infarction and coronary artery disease [1]. The current literature on the effects of plant-based diets on plasma lipids suggests that abiding by a vegetarian diet reliably reduces the plasma cholesterol levels due to the lack of animal products compared to those following an omnivore diet [6]. ...
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Lipids are an essential part of the human diet affecting biological processes and reducing disease development. Plant-based oils, specifically sterols, are essential compounds for cellular composition and proliferation. As vegetarians refrain from consuming animal products, although many versions of this lifestyle exist, plant oils are their only source of fat intake. Extracted plant oils are an essential source of fats and fatty acids; hence this study aims to address vegetarians knowledge and pessimistic perceptions of fats and plant oils to understand the vegetarian consumer choice through the Theory of Planned Behaviour. Despite extensive research on the vegetarian lifestyle, a pessimistic approach to understanding consumer choice in plant-based oils has been less than satisfactory. A qualitative research design was selected to conduct one-to-one in-depth interviews with seventeen vegetarian participants that met the eligibility criteria. Recruitment was based on a purposive sampling drawn from social media groups to provide an insight into the pessimistic views of vegetarians on plant-based oils. A thematic analysis was conducted using the computer-assisted software package NVivo 12 Plus. Pessimistic views and lack of knowledge on the functionality of fats and fatty acids may lead to nutrient deficiencies. The study has identified three major themes related to vegetarians pessimistic views towards plant oils: 1) pessimistic misconceptions of fats and plant-based oils, 2) pessimistic views on plant-based oil harvesting and manufacturing, and 3) plant-based oil challenges and pessimistic health claims. These conflicts are affecting the nutritional status of vegetarians by either avoiding or lessening extracted plant oils in their diet due to a lack of misinformation and uninformative nutritional labelling. The present study highlights the vegetarians' pessimistic perceptions of extracted plant oils. It argues that vegetarians' are more prone to nutritional deficiencies due to a lack of knowledge on the functionality of fats and fatty acids and highlights the need for informative food labelling to enable consumers to make comprehensive food choices.
... Among plant-based diets, current evidence suggests that the Mediterranean and vegetarian diets are associated with numerous health benefits, including a lower risk of CVD [20]. These positive effects may be explained by their high content of dietary fiber, complex carbohydrates, vitamins, minerals, polyunsaturated fatty acids, and phytochemicals [20]. ...
... Among plant-based diets, current evidence suggests that the Mediterranean and vegetarian diets are associated with numerous health benefits, including a lower risk of CVD [20]. These positive effects may be explained by their high content of dietary fiber, complex carbohydrates, vitamins, minerals, polyunsaturated fatty acids, and phytochemicals [20]. Specifically, a recent work by Dinu and colleagues of "The Working Group "Young Members" of the Italian Society of Human Nutrition (SINU)" suggested that the "Mediterranean diet had the strongest and most consistent evidence of a beneficial effect on both anthropometric parameters and cardiometabolic risk factors" [21]. ...
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Excerpt Note: In lieu of an abstract, this is an excerpt from the first page. The transition from premenopause to postmenopause is associated with the development of multiple elements of Metabolic Syndrome (MetS) [...]
... Notably, an unhealthy diet that consists of high sugar, sodium and saturated fats and lower amounts of fruit, vegetables, legumes, fibres, nuts and fish is a critical modifiable risk factor for several chronic diseases, specifically CVDs [23][24][25]. In most cases, a healthy and balanced diet is a part of the treatment/prevention plan for CVDs, including for thrombotic diseases [26]. Several studies have demonstrated the effects of plants-based diets in reduc- ...
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Cardiovascular diseases (CVDs) are a primary cause of deaths worldwide. Thrombotic diseases, specifically stroke and coronary heart diseases, account for around 85% of CVDs-induced deaths. Platelets (small circulating blood cells) are responsible for the prevention of excessive bleeding upon vascular injury, through blood clotting (haemostasis). However, unnecessary activation of platelets under pathological conditions, such as upon the rupture of atherosclerotic plaques, results in thrombus formation (thrombosis), which can cause life threatening conditions such as stroke or heart attack. Therefore, antiplatelet medications are usually prescribed for people who are at a high risk of thrombotic diseases. The currently used antiplatelet drugs are associated with major side effects such as excessive bleeding, and some patients are resistant to these drugs. Therefore, numerous studies have been conducted to develop new antiplatelet agents and notably, to establish the relationship between edible plants, specifically fruits, vegetables and spices, and cardiovascular health. Indeed, healthy and balanced diets have proven to be effective for the prevention of CVDs in diverse settings. A high intake of fruits and vegetables in regular diet is associated with lower risks for stroke and coronary heart diseases because of their plethora of phytochemical constituents. In this review, we discuss the impacts of commonly used selected edible plants (specifically vegetables, fruits and spices) and/or their isolated compounds on the modulation of platelet function, haemostasis and thrombosis.
... They consumed plant-based products such as fruit, pulses, seeds, and nuts, which are sources of vitamins, minerals, and dietary fiber, significantly less frequently. These food products are recommended for the prevention of cardiovascular risk [39]. However, in our study epilepsy patients showed less frequent consumption of vegetables and fruits and sugar sweetened soda, but consumed legumes more often than the epileptic individuals of the California Health Interview Survey [29]. ...
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Background Several factors predispose individuals with epilepsy to chronic diseases. Among them, nutrition and lifestyle factors have not been sufficiently studied. Therefore, the aim of this study was to evaluate patients with epilepsy in terms of diet, body composition and physical activity compared to healthy sex- and age-matched subjects to investigate whether there are risk factors for nutritional deficiencies and risk factors for the development of metabolic diseases. Methods The case-control study involved 60 epileptic male and female volunteers and 70 healthy controls matched according to age and sex. Medical information was collected during the study, and a detailed questionnaire regarding eating and lifestyle habits was conducted. Physical activity was evaluated using the International Physical Activity Questionnaire (IPAQ). Nutritional status was assessed by bioelectric impedance. Venous blood samples were taken for lipid and 25-hydroxyvitamin D3 (25(OH)D3) analyses. Results A tendency toward an increase in LDL cholesterol was found in the individuals with epilepsy. Significantly higher body fat and insignificantly higher visceral fat were found in epileptic men than in healthy men. In epileptic women, a tendency toward a lower lean body mass was found. Patients with epilepsy were more sedentary, consumed less cottage cheese, fruit, pulses, nuts and seeds, vitamin C and potassium, and consumed more sugar-sweetened soda, fat and sodium than healthy people. On a positive note, individuals with epilepsy consumed less coffee and alcoholic beverages. More than 80% of the epileptic volunteers had diets that were low in folic acid, vitamin D and calcium, but a similar tendency was observed in the healthy volunteers. A higher percentage of the patients with epilepsy had diets that were low in niacin, vitamin C and potassium than the control group (25% vs. 7, 50% vs. 31% and 73 vs. 56%, respectively). A significantly lower serum concentration of 25(OH)D3 was observed in epileptic individuals and was found to be positively modulated by physical activity. Conclusions The results indicate that several behavior-related habits, which may predispose epileptic people to cardiovascular disease, need to be improved. For this reason, patients with epilepsy should be provided with more comprehensive medical care, including advice on nutrition and physical activity.
... They have consumed signi cantly less frequently vegetable products such as fruit, pulses, seeds, and nuts, which are sources of vitamins, minerals, and dietary ber. These food products are recommended for the prevention of cardiovascular risk [38]. Compared to other studies [28], epilepsy patients in our study showed less frequent consumption of vegetables and fruits and sugar sweetened soda, while they consumed legumes more often. ...
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Background: Several factors predispose people with epilepsy to cardiovascular diseases. Among them nutrition and lifestyle have not been sufficiently studied. Methods. The study involved 60 epileptic male and female volunteers and 70 healthy controls, corresponding to age and gender. Medical information was collected during the study and a detailed questionnaire survey concerning eating and lifestyle habits was conducted. Physical activity was evaluated using International Physical Activity Questionnaire (IPAQ). Nutritional status was assessed by bioelectric impedance. Venous blood samples were taken for lipid and 25-hydroxyvitamin D3 (25(OH)D3) analyses. Results. A tendency to an increase in LDL cholesterol was found in epileptics. Significantly higher body fat and insignificantly higher visceral fat was found in epileptic men compared to healthy men. In epileptic women a tendency to lower lean body mass was found. Patients with epilepsy were more sedentary, had lower consumption of cottage cheese, fruit, pulses, nuts and seeds, vitamin C and potassium, and higher intake of sugar-sweetened soda, energy from fat and sodium compared to healthy people. As a positive point, epileptics consumed less coffee and alcoholic beverages. More than 80% of diets of epilepsy people were low in folic acid, vitamin D and calcium, but similar tendency was observed in the healthy people. The diets of patients with epilepsy were in a higher percentage poor in niacin, vitamin C and potassium compared to the control group, 25% to 7%, 50% to 31% and 73 to 56% respectively. A significantly lower serum concentration of 25(OH)D3 was observed in epileptic individuals, which in this group was found to be positively modulated by physical activity. Conclusions. The study indicates that several behavior-related habits, which may predispose epileptic people to cardiovascular disease, need to be improved. For this reason, patients with epilepsy should be provided with more comprehensive medical care, including advice on nutrition and physical activity.
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A recent paper in PLOS Medicine showed modeled gains in life expectancy following dietary shifts from a typical Western (TA) to a Feasible (FA) and an Optimal Diet (OD). A Food4HealthyLife calculator was provided on line. However, energy density data for 14 “representative” foods does not correspond to energy density data for 1151 foods in the same food groups from the USDA Department of Agriculture databases. The present recalculation shows that the FA and OD diet plans were lower in saturated fat and added sugar but were higher in energy and sodium, and entailed substantially higher daily diet cost, as based on 2021 national food prices used in the USDA Thrifty Food Plan. First, a diet plan of oatmeal porridge with water, simmered mackerel, half a boiled egg, milk 1%, fresh orange, mixed vegetables, chickpeas, and a handful of nuts and berries is not necessarily the same as a diet of whole grains, seafood, eggs and dairy, vegetables, fruits, nuts and legumes. Second, any well-meaning dietary advice needs to be accompanied by economic feasibility studies and estimates of diet cost. Clinicians, policymakers, and consumers need to understand not only the health impact but also the economic cost of dietary choices. Access to affordable nutrient rich foods is one of the social and political determinants of health.
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Introduction:Cardiovascular disease is a leading cause of death and chronic disability and optimizing its prevention and management remains a priority. This review aims to provide a critical analysis on the positive and negative aspects concerning the impact of a vegetarian diet in cardiovascular risk. Results:Overall, vegetarian population presents better cardiovascular risk profile, expressed by lower body mass index, better blood pressure control, reduced pro-atherogenic lipids and better glycaemic control and insulin sensitivity. Other atherogenic paths seem to be influenced, such as chylomicron remnants removal from circulation, oxidative and inflammation profile, blood fluidity and intestinal microbiota. Furthermore, imaging methods have shown better structural and functional vascular properties among vegetarians. However, a non-balanced vegetarian diet might lead to nutrients deficit, which could nullify these advantages. These limitations may be overcome through a carefully planned diet and, in some cases, supplements or fortified foods. Ultimately, a beneficial effect is associated with a healthy vegetarian concept, with scarce intake of refined and processed food products, avoiding overconsumption of sugar and trans fats. Conclusion:Vegetarian diet brings a positive impact in several independent cardiovascular risk factors. Despite the additional challenge in reaching specific macro and micronutrients which are less available in plant-based foods, their shortage can be avoided by planning a well-balanced and complete diet, based on healthy and natural food components. As there is the acknowledgment of its limitations and corresponding precautions are taken, a vegetarian diet could be used as an effective weapon towards prevention and management of cardiovascular disease
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Background: A 55-year-old, post-menopausal, obese female with obesity-related symptoms seen by a nutritionist using motivational interviewing and self-determination theory assisted a client with an elimination diet and lifestyle modifications to lose weight. Case/intervention: An elimination diet was the primary component of these recommendations, identifying food sensitivities associated with an inability to lose weight. Biomarkers identified abnormalities to help individualize and guide nutritional recommendations. Motivational interviewing and the self-determination theory were used in this functional nutrition approach. Conclusion: Over a six-week period the client had an 18-pound reduction in weight, a loss of 22.5 inches of girth and decreased bloating.
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Research has shown that a greater adherence to the Mediterranean diet is associated with a reduced risk of major chronic disease. However, the existing literature leads to debate for different issues, such as the measurement of the adherence to the Mediterranean diet, the use of a wide variety of dietary indices with various food components and the large heterogeneity across the studies. In order to summarise the evidence and evaluate the validity of the association between the adherence to the Mediterranean diet and multiple health outcomes, an umbrella review of the evidence across meta-analyses of observational studies and randomised clinical trials (RCTs) was performed. Thirteen meta-analyses of observational studies and 16 meta-analyses of RCTs investigating the association between the adherence to the Mediterranean diet and 37 different health outcomes, for a total population of over than 12 800 000 subjects, were identified. A robust evidence, supported by a P-value<0.001, a large simple size, and not a considerable heterogeneity between studies, for a greater adherence to the Mediterranean diet and a reduced the risk of overall mortality, cardiovascular diseases, coronary heart disease, myocardial infarction, overall cancer incidence, neurodegenerative diseases and diabetes was found. For most of the site-specific cancers, as well as for inflammatory and metabolic parameters, the evidence was only suggestive or weak and further studies are needed to draw firmer conclusions. No evidence, on the other hand, was reported for bladder, endometrial and ovarian cancers, as well as for LDL (low density lipoprotein)-cholesterol levels.European Journal of Clinical Nutrition advance online publication, 10 May 2017; doi:10.1038/ejcn.2017.58.
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Objective To determine the association of different types of meat intake and meat associated compounds with overall and cause specific mortality. Design Population based cohort study. Setting Baseline dietary data of the NIH-AARP Diet and Health Study (prospective cohort of the general population from six states and two metropolitan areas in the US) and 16 year follow-up data until 31 December 2011. Participants 536 969 AARP members aged 50-71 at baseline. Exposures Intake of total meat, processed and unprocessed red meat (beef, lamb, and pork) and white meat (poultry and fish), heme iron, and nitrate/nitrite from processed meat based on dietary questionnaire. Adjusted Cox proportional hazards regression models were used with the lowest fifth of calorie adjusted intakes as reference categories. Main outcome measure Mortality from any cause during follow-up. Results An increased risk of all cause mortality (hazard ratio for highest versus lowest fifth 1.26, 95% confidence interval 1.23 to 1.29) and death due to nine different causes associated with red meat intake was observed. Both processed and unprocessed red meat intakes were associated with all cause and cause specific mortality. Heme iron and processed meat nitrate/nitrite were independently associated with increased risk of all cause and cause specific mortality. Mediation models estimated that the increased mortality associated with processed red meat was influenced by nitrate intake (37.0-72.0%) and to a lesser degree by heme iron (20.9-24.1%). When the total meat intake was constant, the highest fifth of white meat intake was associated with a 25% reduction in risk of all cause mortality compared with the lowest intake level. Almost all causes of death showed an inverse association with white meat intake. Conclusions The results show increased risks of all cause mortality and death due to nine different causes associated with both processed and unprocessed red meat, accounted for, in part, by heme iron and nitrate/nitrite from processed meat. They also show reduced risks associated with substituting white meat, particularly unprocessed white meat.
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Cardiovascular diseases (CVDs) are one of the major causes of mortality and disability in Western countries. Prevention is known to be the cornerstone to lessen the incidence of CVDs and also to reduce the economic burden of both the citizen and the healthcare system. The “interventional medicine” certainly puts the lifestyle modification as first therapeutic step, including healthy diet and physical activity. Secondly, a large body of research individuated a number of food and plant bioactives which are potentially efficacious in preventing and reducing some highly prevalent CV risk factors, such as hypercholesterolemia, hypertension, vascular inflammation and vascular compliance. Some lipid- and blood pressure-lowering bioactives were studied for their impact on human vascular health, particularly as regards endothelial function and arterial stiffness. Several nutraceuticals showed additive or synergistic properties in combination, sometimes (but not always) allowing a reduction of the administered dose of extracts and determining a “multi-factorial” final effect on many cardiovascular risk factors. Thus, this review focuses on the available evidence regarding the effects of berberine, plant sterols, green tea extract, soy, curcumin, cocoa, pycnogenol, lycopene, olive oil, soluble fibers, garlic, resveratrol, beetroot, mineral salts and vitamins on lipid profile, blood pressure, inflammatory and endothelial markers, and vascular compliance. Future clinical researches will have to focus more on middle term modification of instrumental markers of vascular aging than on short-term effects on indirect laboratory risk markers.
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Objective. To evaluate the long-term effects of a Mediterranean diet (MeDiet) intervention on the plasma concentrations of inflammatory and plaque stability-related molecules in elderly people at high risk for cardiovascular disease.Design and Setting. 66 participants from primary care centers affiliated with the Hospital Clinic of Barcelona were randomized into 3 groups: MeDiet plus extra virgin olive oil (EVOO) or nuts and a low-fat diet (LFD). At baseline and at 3 and 5 years, we evaluated the changes in the plasma concentrations of 24 inflammatory biomarkers related to the different stages of the atherosclerotic process by Luminex®.Results.At 3 and 5 years, both MeDiet groups showed a significant reduction of IL-6, IL-8, MCP-1, and MIP-1β(P< 0.05; all) compared to LFD. IL-1β, IL-5, IL-7, IL-12p70, IL-18, TNF-α, IFN-γ, GCSF, GMCSF, and ENA78 (P< 0.05; all) only decreased in the MeDiet+EVOO group and E-selectin and sVCAM-1 (P< 0.05; both) in the MeDiet+nuts group.Conclusions. Long-term adherence to MeDiet decreases the plasma concentrations of inflammatory biomarkers related to different steps of atheroma plaque development in elderly persons at high cardiovascular risk.
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The potential cardiovascular benefits of several trending foods and dietary patterns are still incompletely understood, and nutritional science continues to evolve. However, in the meantime, a number of controversial dietary patterns, foods, and nutrients have received significant media exposure and are mired by hype. This review addresses some of the more popular foods and dietary patterns that are promoted for cardiovascular health to provide clinicians with accurate information for patient discussions in the clinical setting.
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Our aimwas to assess the efficacy of dietary supplements in the primary prevention of cause-specific death, cardiovascular disease (CVD), and cancer by using meta-analytical approaches. Electronic and hand searches were performed until August 2016. Inclusion criteria were as follows: 1) minimum intervention period of 12 mo; 2) primary prevention trials; 3) mean age ≥18 y; 4) interventions included vitamins, fatty acids, minerals, supplements containing combinations of vitamins and minerals, protein, fiber, prebiotics, and probiotics; and 5) primary outcome of all-cause mortality and secondary outcomes of mortality or incidence from CVD or cancer. Pooled effects across studies were estimated by using random-effects meta-analysis. Overall, 49 trials (69 reports) including 287,304 participantsmet the inclusion criteria. Thirty-two trials were judged as low risk-, 15 trials asmoderate risk-, and 2 trials as high risk-of-bias studies. Supplements containing vitamin E (RR: 0.88; 95% CI: 0.80, 0.96) significantly reduced cardiovascular mortality risk, whereas supplements with folic acid reduced the risk of CVD (RR: 0.81; 95%CI: 0.70, 0.94). VitaminsD, C, and K; selenium; zinc; magnesium; and eicosapentaenoic acid showed no significant risk reduction for any of the outcomes. On the contrary, vitamin A was linked to an increased cancer risk (RR: 1.16; 95% CI: 1.00, 1.35). Supplements with β-carotene showed no significant effect; however, in the subgroup with β-carotene given singly, an increased risk of all-cause mortality by 6% (RR: 1.06; 95% CI: 1.02, 1.10) was observed. Taken together, we found insufficient evidence to support the use of dietary supplements in the primary prevention of cause-specific death, incidence of CVD, and incidence of cancer. The application of some supplements generated small beneficial effects; however, the heterogeneous types and doses of supplements limit the generalizability to the overall population.
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Background Although nut consumption has been associated with a reduced risk of cardiovascular disease and all-cause mortality, data on less common causes of death has not been systematically assessed. Previous reviews missed several studies and additional studies have since been published. We therefore conducted a systematic review and meta-analysis of nut consumption and risk of cardiovascular disease, total cancer, and all-cause and cause-specific mortality. Methods PubMed and Embase were searched for prospective studies of nut consumption and risk of cardiovascular disease, total cancer, and all-cause and cause-specific mortality in adult populations published up to July 19, 2016. Summary relative risks (RRs) and 95% confidence intervals (CIs) were calculated using random-effects models. The burden of mortality attributable to low nut consumption was calculated for selected regions. Results Twenty studies (29 publications) were included in the meta-analysis. The summary RRs per 28 grams/day increase in nut intake was for coronary heart disease, 0.71 (95% CI: 0.63–0.80, I² = 47%, n = 11), stroke, 0.93 (95% CI: 0.83–1.05, I² = 14%, n = 11), cardiovascular disease, 0.79 (95% CI: 0.70–0.88, I² = 60%, n = 12), total cancer, 0.85 (95% CI: 0.76–0.94, I² = 42%, n = 8), all-cause mortality, 0.78 (95% CI: 0.72–0.84, I² = 66%, n = 15), and for mortality from respiratory disease, 0.48 (95% CI: 0.26–0.89, I² = 61%, n = 3), diabetes, 0.61 (95% CI: 0.43–0.88, I² = 0%, n = 4), neurodegenerative disease, 0.65 (95% CI: 0.40–1.08, I² = 5.9%, n = 3), infectious disease, 0.25 (95% CI: 0.07–0.85, I² = 54%, n = 2), and kidney disease, 0.27 (95% CI: 0.04–1.91, I² = 61%, n = 2). The results were similar for tree nuts and peanuts. If the associations are causal, an estimated 4.4 million premature deaths in the America, Europe, Southeast Asia, and Western Pacific would be attributable to a nut intake below 20 grams per day in 2013. Conclusions Higher nut intake is associated with reduced risk of cardiovascular disease, total cancer and all-cause mortality, and mortality from respiratory disease, diabetes, and infections. Electronic supplementary material The online version of this article (doi:10.1186/s12916-016-0730-3) contains supplementary material, which is available to authorized users.
Article
Multiple randomized controlled trials (RCTs) have assessed the effects of supplementation with eicosapentaenoic acid plus docosahexaenoic acid (omega-3 polyunsaturated fatty acids, commonly called fish oils) on the occurrence of clinical cardiovascular diseases. Although the effects of supplementation for the primary prevention of clinical cardiovascular events in the general population have not been examined, RCTs have assessed the role of supplementation in secondary prevention among patients with diabetes mellitus and prediabetes, patients at high risk of cardiovascular disease, and those with prevalent coronary heart disease. In this scientific advisory, we take a clinical approach and focus on common indications for omega-3 polyunsaturated fatty acid supplements related to the prevention of clinical cardiovascular events. We limited the scope of our review to large RCTs of supplementation with major clinical cardiovascular disease end points; meta-analyses were considered secondarily. We discuss the features of available RCTs and provide the rationale for our recommendations. We then use existing American Heart Association criteria to assess the strength of the recommendation and the level of evidence. On the basis of our review of the cumulative evidence from RCTs designed to assess the effect of omega-3 polyunsaturated fatty acid supplementation on clinical cardiovascular events, we update prior recommendations for patients with prevalent coronary heart disease, and we offer recommendations, when data are available, for patients with other clinical indications, including patients with diabetes mellitus and prediabetes and those with high risk of cardiovascular disease, stroke, heart failure, and atrial fibrillation.
Article
Background: The biological functions of high-density lipoproteins (HDLs) contribute to explaining the cardioprotective role of the lipoprotein beyond quantitative HDL cholesterol levels. A few small-scale interventions with a single antioxidant have improved some HDL functions. However, to date, no long-term, large-scale, randomized controlled trial has been conducted to assess the effects of an antioxidant-rich dietary pattern (such as a traditional Mediterranean diet [TMD]) on HDL function in humans. Methods: This study was performed in a random subsample of volunteers from the PREDIMED Study (Prevención con Dieta Mediterránea; n=296) after a 1-year intervention. We compared the effects of 2 TMDs, one enriched with virgin olive oil (TMD-VOO; n=100) and the other enriched with nuts (TMD-Nuts; n=100), with respect to a low-fat control diet (n=96). We assessed the effects of both TMDs on the role of HDL particles on reverse cholesterol transport (cholesterol efflux capacity, HDL ability to esterify cholesterol, and cholesteryl ester transfer protein activity), HDL antioxidant properties (paraoxonase-1 arylesterase activity and total HDL antioxidant capacity on low-density lipoproteins), and HDL vasodilatory capacity (HDL ability to induce the release of nitric oxide in endothelial cells). We also studied the effects of a TMD on several HDL quality-related characteristics (HDL particle oxidation, resistance against oxidative modification, main lipid and protein composition, and size distribution). Results: Both TMDs increased cholesterol efflux capacity relative to baseline (P=0.018 and P=0.013 for TMD-VOO and TMD-Nuts, respectively). The TMD-VOO intervention decreased cholesteryl ester transfer protein activity (relative to baseline, P=0.028) and increased HDL ability to esterify cholesterol, paraoxonase-1 arylesterase activity, and HDL vasodilatory capacity (relative to control, P=0.039, P=0.012, and P=0.026, respectively). Adherence to a TMD induced these beneficial changes by improving HDL oxidative status and composition. The 3 diets increased the percentage of large HDL particles (relative to baseline, P<0.001). Conclusions: The TMD, especially when enriched with virgin olive oil, improved HDL atheroprotective functions in humans. Clinical trial registration: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639.