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Background: Most subjects regain weight after weight loss due to compensatory adaptations finalized to maintain stable body energy stores. Green tea (GT) preparations, which help maintain energy expenditure while dieting could be a useful strategy to facilitate weight maintenance. The usefulness of GT preparations in weight maintenance has been poorly studied so far with conflicting results. This study evaluated if a supplement of GSP and piperine helps obese women to maintain the weight loss obtained with a 3-month lifestyle intervention. Methods: In a randomized placebo-controlled study, we examined whether a highly bioavailable GT extract may counteract weight regain after weight loss. Forty obese women (age 50.1 ± 10.1 years, Body Mass Index (BMI) 36.3 ± 2.7 kg/m(2)) underwent a 3-month lifestyle intervention. At the end of the intervention, the women were randomized in two groups for the weight-maintenance phase: 20 of them were prescribed twice a day, for 3 months, with a formula containing 150 mg/dose of Greenselect Phytosome® and 15 mg/dose of pure piperine (GSP group), and 20 were given placebo (P group). Anthropometric measures and body composition were measured before (V-3) and after lifestyle intervention (V0), 1 (V1), 2 (V2), and 3 (V3) months after prescribing supplements and 3 months following the discontinuation of supplements (V6). Results: Lifestyle intervention induced a significant weight reduction in both groups with similar weight change (-6.2 ± 2.6 in GSP group vs. -4.8 ± 3.1 % in P group). In the GSP group, V1 in comparison to V0, had further reduction in weight and fat mass, which remained stable at V2 and V3 and increased at V6. In the P group, weight and fat mass increased from V2 onwards. Weight changes in GSP group and P group from V0 to V3 were -1.0 kg (95 % CI -2.5 to +0.5) and + 0.3 kg (95 % CI -0.9 to +1.6), respectively. The proportion of women with weight loss ≥ 5 % was greater in the GSP group than in the P group (75 % vs. 45 % at V1, and 60 % vs. 30 % at V6, p < 0.05 for both groups). Conclusions: Greenselect Phytosome® devoid of caffeine may have a clinical potential for the maintenance of weight after intentional weight loss. Trial registration: Clinicaltrials.gov NCT02542449 (September 2015).
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R E S E A R C H A R T I C L E Open Access
Effects of Greenselect Phytosome®
on weight maintenance after weight
loss in obese women: a randomized
placebo-controlled study
Luisa Gilardini
1*
, Lucia Pasqualinotto
1
, Francesco Di Pierro
2
, Paolo Risso
3
and Cecilia Invitti
1
Abstract
Background: Most subjects regain weight after weight loss due to compensatory adaptations finalized to maintain
stable body energy stores. Green tea (GT) preparations, which help maintain energy expenditure while dieting could
be a useful strategy to facilitate weight maintenance. The usefulness of GT preparations in weight maintenance has
been poorly studied so far with conflicting results. This study evaluated if a supplement of GSP and piperine helps
obese women to maintain the weight loss obtained with a 3-month lifestyle intervention.
Methods: In a randomized placebo-controlled study, we examined whether a highly bioavailable GT extract may
counteract weight regain after weight loss. Forty obese women (age 50.1 ± 10.1 years, Body Mass Index (BMI)
36.3 ± 2.7 kg/m
2
) underwent a 3-month lifestyle intervention. At the end of the intervention, the women were
randomized in two groups for the weight-maintenance phase: 20 of them were prescribed twice a day, for 3 months,
with a formula containing 150 mg/dose of Greenselect Phytosome® and 15 mg/dose of pure piperine (GSP group),
and 20 were given placebo (P group). Anthropometric measures and body composition were measured before (V-3)
and after lifestyle intervention (V0), 1 (V1), 2 (V2), and 3 (V3) months after prescribing supplements and 3 months
following the discontinuation of supplements (V6).
Results: Lifestyle intervention induced a significant weight reduction in both groups with similar weight change
(6.2 ± 2.6 in GSP group vs. 4.8 ± 3.1 % in P group). In the GSP group, V1 in comparison to V0, had further reduction
in weight and fat mass, which remained stable at V2 and V3 and increased at V6. In the P group, weight and fat mass
increased from V2 onwards. Weight changes in GSP group and P group from V0 to V3 were 1.0 kg (95 % CI 2.5
to +0.5) and + 0.3 kg (95 % CI 0.9 to +1.6), respectively.
The proportion of women with weight loss 5 % was greater in the GSP group than in the P group (75 % vs. 45 % at
V1, and 60 % vs. 30 % at V6, p< 0.05 for both groups).
Conclusions: Greenselect Phytosome® devoid of caffeine may have a clinical potential for the maintenance of weight
after intentional weight loss.
Trial registration: Clinicaltrials.gov NCT02542449 (September 2015)
Keywords: Green tea, Weight maintenance, Obesity, Fat mass
* Correspondence: l.gilardini@auxologico.it
1
Department of Medical Sciences and Rehabilitation, IRCCS Istituto
Auxologico Italiano, Via Ariosto 13, 20145 Milan, Italy
Full list of author information is available at the end of the article
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233
DOI 10.1186/s12906-016-1214-x
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Background
Genetic, epidemiological, and physiological studies indi-
cate that body weight is highly regulated, and the
increasing prevalence of obesity reflects the interactions
of genes favoring energy conservation and storage in an
environment that enables access to food calories and a
more sedentary lifestyle. Weight loss can be achieved by
reducing energy intake and at the same time sustaining
energy expenditure. Although weight loss interventions
usually lead to weight loss shortly after intervention,
majority of subjects once again regain weight after the
intervention due to compensatory adaptations finalized
to maintain stable body energy stores. The physiological
adaptation to weight loss involves several biological
pathways mediating the utilization and storage of energy
and the regulation of appetite [1]. In both, lean and
obese individuals, maintenance of a 10 % or greater re-
duction in body weight is associated with a decline in
24-hour energy expenditure of approximately 2025 %
[2]. The restraint of the decline in energy expenditure
while dieting along with GT preparations could be a use-
ful strategy to facilitate weight maintenance. GT contains
a complex mixture of polyphenolic compounds belong-
ing to the family of catechins, mainly epigallocatechin
gallate, which are responsible for most of the pharmaco-
logical activity of GT. The principal mechanisms of GT
are stimulation of fat oxidation through up-regulation of
lipid-metabolizing enzymes and an increase in norepin-
ephrine levels and energy expenditure through inhibition
of catechol-O-methyltransferase [3].
The ability of GT preparations assisting weight loss
was evaluated in a Cochrane Systematic Review that
included 14 randomized controlled trials [4]. This review
concluded that the weight loss produced by GT prepara-
tions is unlikely to be clinically relevant since it was not
statistically significant in majority of the studies. How-
ever, the usefulness of GT preparations in weight main-
tenance has been poorly studied so far with conflicting
results [4].
Despite the wide nutraceuticaluse of GT, pharmaco-
logical and clinical data show that these molecules are
poorly absorbed orally. Formulation with phospholipids
(Phytosome strategy) however, has shown increased ab-
sorption with some classes of natural products, includ-
ing polyphenolics. Thus, the absorption of Greenselect
Phytosome® (GSP) is about 3-fold higher compared to
the unformulated extract [5], and GSP was also shown
to reduce body weight in subjects with obesity and meta-
bolic syndrome [6, 7]. Currently, a new formulation of
GSP combined with piperine, a thermogenic agent, has
been developed. This new formulation increases the
absorption of various phenolics [8] and enhances the
pharmacodynamics of GSP. This study evaluated whether
dietary supplements of GSP and piperine help obese
women to maintain the weight loss obtained with a
3-month lifestyle intervention.
Methods
Study participants
The study sample consisted of 40 obese Caucasian
women who were recruited from those patients referred
to the IRCCS Istituto Auxologico Italiano for a weight-
loss lifestyle intervention. Women with uncontrolled
hypertension and history of cardiovascular or cerebro-
vascular events were excluded from the study. Sample
size was calculated assuming a 5 % weight loss would
be the outcome obtained with 3 months of lifestyle
intervention. The effective size of the study group was
calculated for a binomial test irrespective of weight
loss 5 %, looking for at least a difference of 25 % be-
tween the proportion of women reaching this goal in the
placebo and treatment group. We designed our trial with
an alpha error of 5 % and a power of 95 %. Calculation
was performed using G*Power 3.1, obtaining a sample size
of 42 subjects, that was rounded to 20 women for
each group.
The Ethics Committee of the Istituto Auxologico
Italiano approved the study, and all subjects gave their
informed consent after we provided a full explanation of
the study.
Intervention
All obese women completed a 3-month lifestyle interven-
tion. At the end of the intervention, women were randomly
assigned to two groups for the weight-maintenance phase:
20 of them were prescribed supplements twice a day for
3 months and were named GSP group. This included
Globes® (Pharmextracta, Pontenure, Piacenza, Italy), an
enteric coated formulation containing 150 mg/dose of
Greenselect Phytosome®. Greenselect Phytosome® is a
highly standardized extract of Camellia sinensis, titrated
as > 60 % polyphenols and > 40 % in epigallocatechin-O-
gallate, complexed with soy distearoylphosphatidylcholine,
and pure piperine (15 mg/dose) from Piper nigrum L. The
remaining 20 were designated as the P group and received
placebo twice a day for 3 months, which was undistin-
guishable from the active in terms of size, shape, taste,
odor, primary and secondary packaging. Tested dietary
supplements and placebo were both manufactured in
S.I.I.T. srl (Trezzano S/N, Milan, Italy). Randomization was
done using the sealed envelope system and compliance
was checked by counting the left-over and returned cap-
sules. The whole trial was conducted in blind, including
the subjects and the dietician who collected anthropo-
metric measures and assessed the adherence to diet during
dietary supplements and follow-up visits. All women
attended a monthly clinical visit while they were taking
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 2 of 7
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
dietary supplements and 3 months after the end of the sup-
plement intake (Fig. 1).
Lifestyle intervention consisted of weekly individual
sessions for nutritional education, advice reinforcement
on exercise activity and peer group psychological
support. A self-monitor diary, which included details of
food consumption, daily physical activity and emotional
reactions, was used as a tool for education and rein-
forcement. Daily caloric requirement was calculated
using the Harris-Benedict equation and an individual ac-
tivity factor. A diet based on a 500-kcal/d deficit from
the individual estimated caloric requirement was pre-
scribed. The diet, which was high in vegetables, low in
salt and simple sugars consisted of 25 % of total energy
intake as protein, 20 % as fat and 55 % as carbohydrate.
Fresh foods, at least three fish meals per week and
avoiding alcohol, were recommended. The prescribed
physical activity program was 210 min per week consist-
ing of 70 % moderate-intensity aerobic physical activity
and 30 % muscle-strengthening activities. The patients
dietary compliance and the average weekly level of phys-
ical activity were recorded at each session. Diet history
and levels of physical activity were collected before and
after the 3-month lifestyle intervention. Food energy and
nutrient intake was calculated using a computerized
database and analysis program (Dietosystem version 3.0;
DS Medica S.r.l., Milan, Italy). Physical activity was
assessed using the short version of the International
physical activity questionnaire (IPAQ) that computes the
Metabolic Equivalent (MET: time spent in physical activ-
ity, expressed in minutes per week) [9].
At the end of the 3-month lifestyle intervention,
women were encouraged to continue with the same diet
and physical activity program recommended during life-
style intervention.
Outcome measures
The primary outcome was the proportion of women
with 5 % weight loss during dietary supplements and
three months after their discontinuation in GSP and pla-
cebo group.
The secondary outcomes were the changes in weight
and fat mass during the intake of dietary supplements
and three months after their discontinuation in GSP and
placebo group.
Further outcomes were changes in blood pressure and
heart rate during the intake of dietary supplements and
three months after their discontinuation in GSP and pla-
cebo group.
Measurements
Anthropometric measures, body composition, blood
pressure (BP) and heart rate were measured at V-3, V0,
V1, V2, V3, and V6. Anthropometry was measured using
a body composition analyzer, which measures weight,
height and Body Mass Index (BMI) with joined function
of body fat analysis (Biki 300, Jawon Medical, Korea).
Waist circumference was measured at the level of the
umbilicus. At V0, V3 and V6, the womens adherence to
the diet was recorded by the dietician using a short
questionnaire (9 items) that provided a score ranging
from 0 to 18, where lower values indicate better adher-
ence (Additional file 1). Three BP measurements sepa-
rated by 5 min were obtained in sitting position at each
visit and mean values were used for the analysis.
Statistical analysis
Analysis of variance was used to compare differences
among groups. Frequencies were compared using a χ
2
test.
Paired t-test was used to compare a) differences between
variables at V0 vs. V-3 in each group (Table 1), b) differ-
ences between weight and fat mass at V0 vs. V-3, at V1 vs.
V0, at V2 vs. V1, at V3 vs. V2 and at V6 vs. V3 (Fig. 3).
Logistic regression analysis was used to evaluate the prob-
ability to have a weight reduction 5 % with Globes® with
respect to placebo. A probability value < 0.05 was consid-
ered significant. Data are given as the means ± SD. All
analyses were performed using SPSS version 22.0 (SPSS,
Chicago, IL, US).
Results
The adherence to dietary supplements was complete in
both groups and all subjects completed the study. The
flow of patients in the study is shown in Fig. 2. Table 1
shows the characteristics of obese women belonging to
GSP and P groups before (V-3) and after the 3-month
lifestyle intervention (V0). No differences were observed
between the two groups at V-3 except for the energy
intake that was greater in the GSP group than in the
P group. At V0, the energy intake decreased and physical
activity increased in both groups (Additional file 2). The
intervention induced a significant weight reduction in
both groups with similar weight changes (6.2 ± 2.6 in
Fig. 1 Study design
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 3 of 7
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
GSP group vs. 4.8 ± 3.1 % in P group, NS). At V0
anthropometric measures, BP and heart rate were similar
in both groups.
Changes in weight and fat mass during the study
period are depicted in Fig. 3. At the first month of
dietary supplements (V1), the GSP group showed a fur-
ther reduction in weight and fat mass that remained stable
at V2 and V3 and increased three months after discon-
tinuation of the supplements (V6). In the P group, weight
and fat mass started to increase at V2. Weight change
Table 1 Characteristics of obese women of GSP and P group before and after the 3-month lifestyle intervention
GSP group (n= 20) P group (n= 20)
V-3 V0 V-3 V0
Age, years 47.6 ± 10.3 - 52.6 ± 9.6 -
Hypertension, % 10 - 35 -
Diabetes, % 5 - 15 -
Weight, kg 94.3 ± 9.8 88.4 ± 9.1** 90.6 ± 6.6 86.3 ± 5.6**
Waist circumference, cm 112.5 ± 10.0 107.1 ± 10.1** 113.9 ± 5.4 110.3 ± 5.7**
Fat mass, kg 43.0 ± 5.8 40.9 ± 5.7** 41.9 ± 3.5 40.7 ± 3.5*
Fat mass/soft lean mass, ratio 0.98 ± 0.10 0.96 ± 0.11 1.0 ± 0.09 0.99 ± 0.08
Systolic BP, mmHg 126.0 ± 13.9 120.5 ± 10.7* 123.7 ± 10.9 119.2 ± 8.6
Diastolic BP, mmHg 79.0 ± 6.4 77.2 ± 4.7 79.5 ± 6.8 77.5 ± 5.3
Heart rate, beats/min 73.8 ± 8.6 73.1 ± 6.9 73.4 ± 9.1 70.7 ± 6.7*
V-3: before lifestyle intervention. V0: after the 3-month lifestyle intervention-start of dietary supplements. *p< 0.05, **p< 0.0001 compared to V-3. Comparisons
between GSP and P group were NS at V3 and at V0
Fig. 2 Flow of patients in the study
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 4 of 7
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
from V0 toV3 was 1.0 kg (95 % CI 2.5 to +0.5) in the
GSP group and+0.3 kg (95 % CI 0.9 to +1.6) in the
Pgroup.
The adherence to the diet progressively decreased in
both groups from V0 to V6. Scores in GSP group were
5.4 ± 3.9 at V3, 2.2 ± 1.3 at V0 (p< 0.05 for V3 vs. V0),
and 6.4 ± 4.9 at V6 (p= NS for V3 vs. V6). The scores in
P group were 5.2 ± 4.0 at V3, 2.8 ± 1.6 at V0 (p< 0.05 for
V3 vs. V0), and 7.8 ± 3.3 at V6 (p< 0.05 for V3 vs. V6).
Advices on physical activity were apparently followed in
both groups because fat-free mass remained stable from
V0 to V6: scores in GSP group were 54.1 ± 3.3 % at V3,
53.8 ± 2.7 % at V0 (p= NS for V3 vs. V0), and 54.6 ± 3.8 %
at V6 (p= NS for V0 and V3). In the P group, the scores
were 52.6 ± 2.9 at V3, 53.0 ± 2.1 at V0 (p<0.05 for V3
vs. V0) and 53.2 ± 5.1 at V6 (p<0.05 when compared
to V0 and V3).
Blood pressure and heart rate remained stable from
V0 to V6 in both groups (data not shown).
The proportion of obese women who maintained a
weight loss 5 % was greater in the GSP than in the
Pgroup(75%vs.45%atV1and60%vs.30%at
V6, p< 0.05 for both). The logistic regression analysis
demonstrated a significantly higher probability to main-
tain a 5 % weight loss at V1 and V6 in the GSP group
than in the P group (Fig. 4).
Discussion
Results of this study indicate that after a weight loss
intervention, obese women supplemented with GSP are
more likely to maintain the reduction in body weight
achieved with the diet than those receiving placebo. In-
deed, we observed that weight and fat mass decreased
during the first month of dietary supplements with GSP
and then remained stable during the period of supple-
ment intake despite the decrease in the adherence to the
diet. Conversely, the weight and fat mass of women be-
longing to the P group started to rise one month after
the end of the lifestyle intervention. The trend to return
to the pre-body fatness is an expected event after suc-
cessful weight loss because of the occurrence of coordin-
ate actions of behavioral, metabolic, neuroendocrine,
and autonomic responses that are designed to maintain
body energy stores [2]. GT has been shown to stimulate
daily energy expenditure by 44.8 % [10, 11], particularly
under conditions of elevated sympathetic tone [12] such
as obesity. GSP may be therefore more useful to offset
the reduction in energy expenditure caused by the adap-
tive thermogenesis when given in association with a
weight loss program. In fact, during a low calorie diet
and adequate physical activity, the increase in the daily
energy expenditure induced by GSP might not be effect-
ive enough due to the overriding effects of the initial
changes in diet and physical activity. This finding is
likely to explain the modest effects of GT on weight loss
reported in the majority of randomized intervention
studies [4, 13].
Few studies reported the effects of GT extracts on
weight maintenance after a period of weight loss in over-
weight and moderately obese subjects. In a study by
Kovasc et al., a 4-week weight loss period with a very
low caloric diet was followed by a 13-week weight main-
tenance period in which, the subjects consumed their
habitual diet and received GT-caffeine mixture or pla-
cebo. No significant differences in body weight regain
were observed between the GT and placebo group how-
ever, a higher weight regain was observed in high caf-
feine consumers [14]. In another study, the same group
confirmed that GTcaffeine mixtures may induce fur-
ther weight reductions during the weight maintenance
Fig. 3 Weight (left panel) and fat mass (right panel) in GSP group (solid line) and P group (dashed line) at V-3, 0, 1, 2, 3 and 6; p values indicate
differences between values at a defined visit and the preceding visit within each group. If the difference is not significant, the p value is not indicated
Fig. 4 Effect of Greenselect Phytosome® compared to placebo on
the probability to maintain a 5 % weight loss at V1, 2, 3 and 6
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 5 of 7
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
period only in low-level caffeine consumers [15]. These
studies are not comparable to our study that utilized a
GSP preparation devoid of caffeine, but with active poly-
phenols complexed with soy phospholipids and piperine
to enhance bioavailability and stimulate thermogenesis.
We observed that the effect of Globes® on body fatness
disappears after its discontinuation. This pattern does
not seem be due to a lower adherence to lifestyle recom-
mendations, because in GSP group the adherence to the
diet and fat-free mass (proxy of physical activity) were
similar between the end of the intake of dietary supple-
ments and follow-up. If we consider that the decline of
energy expenditure occurring after weight loss persists
for at least one year [2], it can be assumed that GSP
preparations should be taken for several months after
the intensive phase of a diet to favor weight mainten-
ance. This remains a hypothesis because energy expend-
iture was not assessed in this study. Future research
having energy expenditure and respiratory quotient as
primary endpoints would perhaps shed light on the
mechanisms by which Globes® affect body fatness.
Finally, we emphasize that dietary supplements with
Globes® did not affect blood pressure and heart rate
levels, suggesting that the increase in sympathetic
activity induced by GSP was not associated to significant
cardiovascular changes.
Conclusion
We believe that GSP extracts devoid of caffeine may
have a clinical potential for the maintenance of weight
after the intentional weight loss. More prolonged ran-
domized studies are needed to confirm these effects and
evaluate the dose of GSP required to achieve expected
results.
Additional files
Additional file 1: Questionnaire for the evaluation of adherence to the
diet. (DOCX 16 kb)
Additional file 2: Table S1. Dietary composition and physical activity
of obese women of GSP and P group before and after the 3-month
lifestyle intervention. (DOCX 16 kb)
Abbreviations
BP, blood pressure; GSP, greenselect phytosome®; GT, green tea; MET, metabolic
equivalent; P, placebo; V, visit
Acknowledgements
Not applicable.
Funding
None.
Availability of supporting data
Reference: Dataset GSP trial in LabArchives.
Authorscontributions
LG performed the statistical analysis, interpretation of data and drafted the
manuscript. CI participated in the design and coordination of the study and
in the interpretation of data, and drafting the manuscript. LP recruited
participants and collected data. FDP conceived the study and helped in
interpreting data and revising the manuscript. All authors read and approved
the final manuscript.
Authorsinformation
Not applicable.
Competing interests
Francesco Di Pierro is the main formulator of Globes®. The other Authors do
not report any conflict of interest.
Consent for publication
Not applicable.
Ethic approval and consent to participate
The Ethics Committee of the Istituto Auxologico Italiano approved the study,
and all subjects gave their informed consent after we provided a full
explanation of the study.
Author details
1
Department of Medical Sciences and Rehabilitation, IRCCS Istituto
Auxologico Italiano, Via Ariosto 13, 20145 Milan, Italy.
2
Scientific Department,
Velleja Research, Milan, Italy.
3
Department of Health Sciences (DISSAL),
University of Genoa, Genoa, Italy.
Received: 9 September 2015 Accepted: 14 July 2016
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... The effects of green tea found in the literature on body weight, in different populations, corroborate our findings. Besides reducing body weight, green tea is also associated with a protective effect on weight gain, even with increased energy intake after a period of interruption of supplementation [24] , weight maintenance [25] , and probability to maintain weight loss greater than or equal to 5% [26] , when compared with studies with a placebo group. ...
Article
Among the main consequences of PCOS, are mentioned menstrual dysfunction, infertility, hyperandrogenism, insulin resistance, weight gain and, in aggravated cases, it can become a risk factor for the development of metabolic syndromes and cardiovascular diseases. We hypothesize that green tea can be an option to complement the treatment of PCOS. Thus, this systematic review aims to evaluate the effects of green tea supplementation in women with PCOS. We searched for randomized controlled trials (RCTs) that evaluated women with PCOS who received green tea compared to placebo in the electronic databases: MEDLINE via PubMed, EMBASE via Elsevier, Cochrane Library, LILACS via BVS and Web of Science, using the terms: “polycystic ovary syndrome”, “green tea”, “Camellia sinenses”, “epigallocatechin gallate”. The outcomes listed in the study protocol were: body weight, fasting insulin, body mass index, body fat percentage, daily caloric intake, waist circumference, hip circumference, waist/hip ratio. Four double-blind RCT were included, with a total of 169 women: 85 in the green tea group (GTG) and 84 in the placebo group (PG). We found a significant lower body weight (kg) for green tea group (MD -2.80; 95%CI -5.25 to -0.35; P = 0.03; I² = 0%, four studies, 169 participants, very low-quality evidence). Green tea has potential positive effects for the reduction of weight and future studies will probably confirm the estimated effect size, thus we reasonably expect as an option of adjuvant treatment in the clinical management of PCOS. Registration number: CRD42021226296.
... Results of the study indicated that patients supplemented with the formulation maintained the bodyweight reduction previously achieved than those receiving placebo. 285 These latest results confirm previous observations by Di Pierro et al in which the formulation, combined with low-calorie diet intake, increased weight loss, and reduced significantly BMI. 286 Formulations including pure flavonoids quercetin or chrysin have been exploited at different levels on parameters related to MS. ...
Article
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Nowadays, medicinal herbs and their phytochemicals have emerged as a great therapeutic option for many disorders. However, poor bioavailability and selectivity might limit their clinical application. Therefore, bioavailability is considered a notable challenge to improve bio-efficacy in transporting dietary phytochemicals. Different methods have been proposed for generating effective carrier systems to enhance the bioavailability of phytochemicals. Among them, nano-vesicles have been introduced as promising candidates for the delivery of insoluble phytochemicals. Due to the easy preparation of the bilayer vesicles and their adaptability, they have been widely used and approved by the scientific literature. The first part of the review is focused on introducing phytosome technology as well as its applications, with emphasis on principles of formulations and characterization. The second part provides a wide overview of biological activities of commercial and non-commercial phytosomes, divided by systems and related pathologies. These results confirm the greater effectiveness of phytosomes, both in terms of biological activity or reduced dosage, highlighting curcumin and silymarin as the most formulated compounds. Finally, we describe the promising clinical and experimental findings regarding the applications of phytosomes. The conclusion of this study encourages the researchers to transfer their knowledge from laboratories to market, for a further development of these products.
... The administrated formulation was used to control the weight in obese patients following their weight loss, and this study is currently in phase IV in clinical trial. The result showed a significant effect of green tea extract phytosomal preparation in maintaining the weight in obese patients following their weight loss ® [89]. Grape seed extract was also investigated in clinical trial to explore its efficacy against early stages lung cancer when prepared as phytosome-based formulation (ClinicalTrials.gov ...
Article
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The emergence of phytosome nanotechnology has a potential impact in the field of drug delivery and could revolutionize the current state of topical bioactive phytochemicals delivery. The main challenge facing the translation of the therapeutic activity of phytochemicals to a clinical setting is the extremely low absorption rate and poor penetration across biological barriers (i.e., the skin). Phytosomes as lipid-based nanocarriers play a crucial function in the enhancement of pharmacokinetic and pharmacodynamic properties of herbal-originated polyphenolic compounds, and make this nanotechnology a promising tool for the development of new topical formulations. The implementation of this nanosized delivery system could enhance the penetration of phytochemicals across biological barriers due to their unique physiochemical characteristics, improving their bioavailability. In this review, we provide an outlook on the current knowledge of the biological barriers of phytoconstituents topical applications. The great potential of the emerging nanotechnology in the delivery of bioactive phytochemicals is reviewed, with particular focus on phytosomes as an innovative lipid-based nanocarrier. Additionally, we compared phytosomes with liposomes as the gold standard of lipid-based nanocarriers for the topical delivery of phytochemicals. Finally, the advantages of phytosomes in topical applications are discussed.
... Green select phytosome has been evaluated for weight maintenance (Gilardini et al., 2016). Furthermore, thermogel of nanosized soy phytosomes have also been investigated for anti-obesity effect (El-Menshawe et al., 2018). ...
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Phytosomes are phytochemical based novel drug delivery systems that lead to better absorption, greater bioavailability in addition to improved therapeutic efϐicacy of numerous phytoconstituents. It is a supremely advanced form of herbal formulations which contains the active phytoconstituent of herbal extract bound by phospholipid molecule. Additionally, these also act as vesicular systems for various fascinating and signiϐicant phytoactive. The phytosomes technique produces remarkable minute spheres of tiny cells, which is helpful in the protection of active phytochemical constituent from destruction by the gastric environment. Furthermore, phytosomes also reveal efϐicient pharmacokinetic as well as pharmacodynamic proϐile compared to conventional herbal extracts. The current manuscript is a cogent attempt to review the potential pharmacological beneϐits of herbal extracts by forming an impressive and successful phytophospholipid complex. Salient attributes, as well as promising and imperative applications of phytosomes, are illustrated in the manuscript. Recent advances in research endeavours, along with major inferences on effective phytosomal drug delivery systems, have also been highlighted.
... CRD triggers adaptive responses by declining energy expenditure, which may persist for at least one year after the weight loss (44). Studies that assessed the effects of polyphenols after diet-induced weight loss found a prevention of weight regain by polyphenols (45,46). These findings suggest that polyphenols might be more effective after the dynamic phase of the CRD in order to favor weight maintenance rather than for reducing weight per se during the CRD. ...
Article
Full-text available
Background: Both, calorie restricted diets (CRD) and physical activity (PA) are conventional obesity therapies but their effectiveness is usually limited in the long-term. Polyphenols are bioactive compounds that have shown to possess some anti-obesity properties. The synergic effects between dietary polyphenols and CRD or PA on body weight and fat are supported by several animal studies, but evidence in human is still inconsistent. Thus, our aim was to review the combined effects of polyphenol supplementation with CRD and/or PA on body weight and fat, body mass index (BMI) and waist circumference (WC) in overweight or obese adults.Methods: Electronic databases (PubMed, Web of Science and Cochrane CENTRAL) were searched for randomized clinical trials (RCT) examining the combination of polyphenols with CRD and/or PA (up to December 31st, 2019). Articles were included if they had a duration of intervention ≥ 4 weeks. Both, quality and risk of bias of the included studies were assessed using the Cochrane RoB2 Tool.Results: The review included 4 and 11 RCTs investigating the anti-obesity effects of polyphenol supplementation combined with CRD and PA, respectively. Isoflavone supplementation may increase fat loss during exercise among post-menopausal women in non-Asian studies. In the rest of RCTs regarding polyphenol supplementation and CRD or PA, no additive changes were found.Conclusion: The results do not yet support polyphenol supplementation as a complementary strategy for enhancing the effectiveness of CRD and PA on weight and fat loss. However, this review suggests that isoflavone and soy products combined with lifestyle changes, especially exercise, provide additional anti-obesity effects in postmenopausal women. The potential role of polyphenols alone or, especially, in addition to conventional therapies (CRD and PA) mostly remains uncertain; and therefore, larger and longer RCTs examining these effects are needed.Protocol Registration: PROSPERO CRD42020159890.
... Significant reductions in all lipid indices, along with serum total cholesterol, LDL-C, HDLC, triglycerides, and non-HDL-C were noticed as well as an appreciable decrease in serum uric acid level [34]. In another randomized placebocontrolled study, 40 obese women with a 3-month lifestyle intervention received phytosomes of green tea extract (Greenselect Phytosome®) with the aim of weight maintenance after deliberately weight loss to overcome the weight regain by maintaining energy expenditure [35]. A formula containing 150 mg/dose of Greenselect Phytosome® and 15 mg/dose of pure piperine was administered twice a day, for 3 months. ...
Chapter
Prebiotics are selectively fermented substrates that are utilized by host microorganisms and allow specific changes to the gastrointestinal microbiota that confer potential health benefits. Probiotics are live organisms which, when taken enterally, may confer a health benefit to the host. Dietary supplements are over-the-counter products taken orally that contain dietary ingredients such as vitamins, minerals, amino acids, herbs, botanicals, or other substances whose use to promote heath or treat illness does not require medical supervision. Dietary supplements that have been studied for their possible role in gastrointestinal conditions include peppermint, ginger, and licorice, among others. Medical foods, which are foods formulated to be consumed under the supervision of a physician and intended for the dietary management of an illness, have also been studied for their potential role in gastrointestinal disease. This chapter summarizes available data regarding the role of prebiotics, probiotics, dietary supplements, and medical foods in gastrointestinal disorders.
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Translation of traditional knowledge of herbs into a viable product for clinical use is still an uphill task. Piperine, a pungent alkaloid molecule derived from Piper nigrum and Piper longum possesses diverse pharmacological effects. Traditionally, pepper is used for arthritis, bronchitis, gastritis, diarrhea, snake bite, menstrual pain, fever, and bacterial infections, etc. The anti-inflammatory, antioxidant and immunomodulatory actions of piperine are the possible mechanisms behind its therapeutic potential. Various in-silico and experimental studies have shown piperine as a possible promising molecule in coronavirus disease (COVID-19), ebola, and dengue due to its immunomodulatory and antiviral activities. The other important clinical applications of piperine are due to its bio enhancing effect on drugs, by modulating, absorption in the gastrointestinal tract, altering activities of transporters like p-glycoprotein substrates, and modulating drug metabolism by altering the expression of cytochrome P450 or UDP-glucuronosyltransferase enzymes. Piperine attracted clinicians in treating patients with arthritis, metabolic syndrome, diabetes, skin infections, gastric and liver disorders. This review focused on systematic, evidence-based insight into the use of piperine in clinical settings and mechanistic details behind its therapeutic actions. Also, highlights a number of clinical trials of piperine at various stages exploring its clinical application in cancer, neurological, respiratory, and viral disease, etc.
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Plants have been used as traditional medicine since ancient times for treating the diseases, metabolite active compounds from plants have excellent bioactivity, and pharmacological properties from plants are used as skin whitening agent and antioxidant in multiple mechanisms of action. However, these compounds have physicochemical limitations in terms of its poor solubility and penetration into the cells membrane. Phytosome drug delivery system can be the primary choice to improve the physicochemical properties, which allows increasing the effectiveness. This review aimed to summarize and discuss the phytosome formulations of potential active compounds as skin whitening agent and skin antioxidant, which obtained from Scopus, PubMed, and Google Scholar databases. We assessed that the main purpose of these phytosome formulations was to improve penetration, stability, and solubility of the active compounds. These studies proved that phytosome formulations can improve the physicochemical characteristics and effectiveness of compounds. The phytosome drug delivery system becomes a promising modification technique for natural compounds due to the ability to improve the physicochemical properties and increase the effectiveness. Phytosome formulation could be the excellent approach for cosmeceutical product with good effectivity in the future.
Article
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Piperine is a natural ingredient of Piper nigrum (black pepper) and some other Piper species. Compared to the use of pepper for food seasoning, piperine is used in food supplements in an isolated, concentrated form and ingested as a bolus. The present review focuses on the assessment of the possible critical health effects regarding the use of isolated piperine as a single ingredient in food supplements. In human and animal studies with single or short-term bolus application of isolated piperine, interactions with several drugs, in most cases resulting in increased drug bioavailability, were observed. Depending on the drug and extent of the interaction, such interactions may carry the risk of unintended deleteriously increased or adverse drug effects. Animal studies with higher daily piperine bolus doses than in human interaction studies provide indications of disturbance of spermatogenesis and of maternal reproductive and embryotoxic effects. Although the available human studies rarely reported effects that were regarded as being adverse, their suitability for detailed risk assessment is limited due to an insufficient focus on safety parameters apart from drug interactions, as well as due to the lack of investigation of the potentially adverse effects observed in animal studies and/or combined administration of piperine with other substances. Taken together, it appears advisable to consider the potential health risks related to intake of isolated piperine in bolus form, e.g., when using certain food supplements.
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The beneficial effects of Greenselect Phytosome, a proprietary lecithin formulation of a caffeine-free green tea catechin extract, were evaluated in a controlled registry study on 50 asymptomatic subjects borderline for metabolic syndrome factors and with increased plasma oxidative stress. After 24 weeks of intervention, improvement in weight, blood lipid profile, and blood pressure positioned 68% of subjects in the treatment arm out of the metabolic syndrome profile, while 80% of the subjects in the control group still remained in their initial borderline disease signature. Compared to the control (lifestyle and dietary changes alone), Greenselect Phytosome was especially effective for weight/waist changes. These results highlight the relevance of addressing multiple factors involved in the development of metabolic syndrome with a pleiotropic agent capable of improving the beneficial effects of lifestyle and dietary changes and foster the attainment of a globally improved health profile.
Article
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The aim of the present study was to examine the effects of green tea epigallocatechin-3-gallate (EGCG) on changes in body composition, energy and substrate metabolism, cardiometabolic risk factors and liver function enzymes after an energy-restricted diet intervention in obese women. In the present randomised, double-blind, placebo-controlled study, eighty-three obese (30 kg/m2>BMI < 40 kg/m2) pre-menopausal women consumed 300 mg/d of EGCG or placebo (lactose). We measured body weight and adiposity (dual-energy X-ray absorptiometry), energy expenditure and fat oxidation rates (indirect calorimetry), blood lipid levels (TAG, total cholesterol, LDL-cholesterol and HDL-cholesterol), insulin resistance, C-reactive protein and liver function markers (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, γ-glutamyltransferase, urea, bilirubin and 2-keto[1-13C]isocaproate oxidation) before and after the intervention in the EGCG and control groups. We did not find any significant difference in the changes in body weight ( - 0·3 kg, 95 % CI - 5·0, 4·3), fat mass ( - 0·7 kg, 95 % CI - 3·5, 2·1), energy (0·3 kJ/kg per d, 95 % CI - 3·1, 2·7) and fat ( - 0·1 g/min, 95 % CI - 0·03, 0·01) metabolism, homeostasis assessment model for insulin resistance (0·2, 95 % CI - 0·2, 0·7), total cholesterol ( - 0·21 mmol/l, 95 % CI - 0·55, 0·13), LDL-cholesterol ( - 0·15 mmol/l, 95 % CI - 0·50, 0·20), TAG ( - 0·14 mmol/l, 95 % CI - 0·56, 0·29) and liver function markers between the EGCG and control groups. In conclusion, the present results suggest that dietary supplementation with 300 mg/d of EGCG for 12 weeks did not enhance energy-restricted diet-induced adiposity reductions, and did not improve weight-loss-induced changes in cardiometabolic risk factors in obese Caucasian women. The intake of 300 mg/d of EGCG for 12 weeks did not cause any adverse effect on liver function biomarkers.
Article
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Preparations of green tea are used as aids in weight loss and weight maintenance. Catechins and caffeine, both contained in green tea, are each believed to have a role in increasing energy metabolism, which may lead to weight loss. A number of randomised controlled trials (RCTs) evaluating the role of green tea in weight loss have been published; however, the efficacy of green tea preparations in weight loss remains unclear. To assess the efficacy and safety of green tea preparations for weight loss and weight maintenance in overweight or obese adults. We searched the following databases from inception to specified date as well as reference lists of relevant articles: The Cochrane Library (Issue 12, 2011), MEDLINE (December 2011), EMBASE (December 2011), CINAHL (January 2012), AMED (January 2012), Biological Abstracts (January 2012), IBIDS (August 2010), Obesity+ (January 2012), IPA (January 2012) and Web of Science (December 2011). Current Controlled Trials with links to other databases of ongoing trials was also searched. RCTs of at least 12 weeks' duration comparing green tea preparations to a control in overweight or obese adults. Three authors independently extracted data, assessed studies for risk of bias and quality, with differences resolved by consensus. Heterogeneity of included studies was assessed visually using forest plots and quantified using the I(2) statistic. We synthesised data using meta-analysis and descriptive analysis as appropriate; subgroup and sensitivity analyses were conducted. Adverse effects reported in studies were recorded. Due to the level of heterogeneity among studies, studies were divided into two groups; those conducted in Japan and those conducted outside Japan. Study length ranged between 12 and 13 weeks. Meta-analysis of six studies conducted outside Japan showed a mean difference (MD) in weight loss of -0.04 kg (95% CI -0.5 to 0.4; P = 0.88; I(2) = 18%; 532 participants). The eight studies conducted in Japan were not similar enough to allow pooling of results and MD in weight loss ranged from -0.2 kg to -3.5 kg (1030 participants) in favour of green tea preparations. Meta-analysis of studies measuring change in body mass index (BMI) conducted outside Japan showed a MD in BMI of -0.2 kg/m(2) (95% CI -0.5 to 0.1; P = 0.21; I(2) = 38%; 222 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed a reduction in BMI ranging from no effect to -1.3 kg/m(2) (1030 participants), in favour of green tea preparations over control. Meta-analysis of five studies conducted outside Japan and measuring waist circumference reported a MD of -0.2 cm (95% CI -1.4 to 0.9; P = 0.70; I(2) = 58%; 404 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed effects on waist circumference ranging from a gain of 1 cm to a loss of 3.3 cm (1030 participants). Meta-analysis for three weight loss studies, conducted outside Japan, with waist-to-hip ratio data (144 participants) yielded no significant change (MD 0; 95% CI -0.02 to 0.01). Analysis of two studies conducted to determine if green tea could help to maintain weight after a period of weight loss (184 participants) showed a change in weight loss of 0.6 to -1.6 kg, a change in BMI from 0.2 to -0.5 kg/m(2) and a change in waist circumference from 0.3 to -1.7 cm. In the eight studies that recorded adverse events, four reported adverse events that were mild to moderate, with the exception of two (green tea preparations group) that required hospitalisation (reported as not associated with the intervention). Nine studies reported on compliance/adherence, one study assessed attitude towards eating as part of the health-related quality of life outcome. No studies reported on patient satisfaction, morbidity or cost. Green tea preparations appear to induce a small, statistically non-significant weight loss in overweight or obese adults. Because the amount of weight loss is small, it is not likely to be clinically important. Green tea had no significant effect on the maintenance of weight loss. Of those studies recording information on adverse events, only two identified an adverse event requiring hospitalisation. The remaining adverse events were judged to be mild to moderate.
Article
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After weight loss, changes in the circulating levels of several peripheral hormones involved in the homeostatic regulation of body weight occur. Whether these changes are transient or persist over time may be important for an understanding of the reasons behind the high rate of weight regain after diet-induced weight loss. We enrolled 50 overweight or obese patients without diabetes in a 10-week weight-loss program for which a very-low-energy diet was prescribed. At baseline (before weight loss), at 10 weeks (after program completion), and at 62 weeks, we examined circulating levels of leptin, ghrelin, peptide YY, gastric inhibitory polypeptide, glucagon-like peptide 1, amylin, pancreatic polypeptide, cholecystokinin, and insulin and subjective ratings of appetite. Weight loss (mean [±SE], 13.5±0.5 kg) led to significant reductions in levels of leptin, peptide YY, cholecystokinin, insulin (P<0.001 for all comparisons), and amylin (P=0.002) and to increases in levels of ghrelin (P<0.001), gastric inhibitory polypeptide (P=0.004), and pancreatic polypeptide (P=0.008). There was also a significant increase in subjective appetite (P<0.001). One year after the initial weight loss, there were still significant differences from baseline in the mean levels of leptin (P<0.001), peptide YY (P<0.001), cholecystokinin (P=0.04), insulin (P=0.01), ghrelin (P<0.001), gastric inhibitory polypeptide (P<0.001), and pancreatic polypeptide (P=0.002), as well as hunger (P<0.001). One year after initial weight reduction, levels of the circulating mediators of appetite that encourage weight regain after diet-induced weight loss do not revert to the levels recorded before weight loss. Long-term strategies to counteract this change may be needed to prevent obesity relapse. (Funded by the National Health and Medical Research Council and others; ClinicalTrials.gov number, NCT00870259.).
Article
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The increasing prevalence of obesity and its comorbidities reflects the interaction of genes that favor the storage of excess energy as fat with an environment that provides ad libitum availability of energy-dense foods and encourages an increasingly sedentary lifestyle. Although weight reduction is difficult in and of itself, anyone who has ever lost weight will confirm that it is much harder to keep the weight off once it has been lost. The over 80% recidivism rate to preweight loss levels of body fatness after otherwise successful weight loss is due to the coordinate actions of metabolic, behavioral, neuroendocrine and autonomic responses designed to maintain body energy stores (fat) at a central nervous system-defined 'ideal'. This 'adaptive thermogenesis' creates the ideal situation for weight regain and is operant in both lean and obese individuals attempting to sustain reduced body weights. Much of this opposition to sustained weight loss is mediated by the adipocyte-derived hormone 'leptin'. The multiple systems regulating energy stores and opposing the maintenance of a reduced body weight illustrate that body energy stores in general and obesity in particular are actively 'defended' by interlocking bioenergetic and neurobiological physiologies. Important inferences can be drawn for therapeutic strategies by recognizing obesity as a disease in which the human body actively opposes the 'cure' over long periods of time beyond the initial resolution of symptomatology.
Article
(-)-Epigallocatechin-3-gallate (EGCG), from green tea (Camellia sinensis), has demonstrated chemopreventive activity in animal models of carcinogenesis. Previously, we reported the bioavailability of EGCG in rats (1.6%) and mice (26.5%). Here, we report that cotreatment with a second dietary component, piperine (from black pepper), enhanced the bioavailability of EGCG in mice. Intragastric coadministration of 163.8 mumol/kg EGCG and 70.2 mumol/kg piperine to male CF-1 mice increased the plasma C,a and area under the curve (AUC) by 1.3-fold compared to mice treated with EGCG only. Piperine appeared to increase EGCG bioavailability by inhibiting glucuronidation and gastrointestinal transit. Piperine (100 mumol/L) inhibited EGCG glucuronidation in mouse small intestine (by 40%) but not in hepatic microsomes. Piperine (20 mumol/L) also inhibited production of EGCG-3"-glucuronide in human HT-29 colon adenocarcinoma cells. Small intestinal EGCG levels in CF-1 mice following treatment with EGCG alone had a C-max = 37.50 +/- 22.50 nmol/g at 60 min that then decreased to 5.14 +/- 1.65 nmol/g at 90 min; however, cotreatment with piperine resulted in a C-max = 31.60 +/- 15.08 nmol/g at 90 min, and levels were maintained above 20 nmol/g until 180 min. This resulted in a significant increase in the small intestine EGCG AUC (4621.80 +/- 1958.72 vs. 1686.50 +/- 757.07 (nmol/g(.)min)). EGCG appearance in the colon and the feces of piperine-cotreated mice was slower than in mice treated with EGCG alone. The present study demonstrates the modulation of the EGCG bioavailablity by a second dietary component and illustrates a mechanism for interactions between dietary chemicals.
Article
Maintaining the level of daily energy expenditure during weight loss and weight maintenance is as important as maintaining satiety while decreasing energy intake. In this context, different catechin- and caffeine-rich teas (CCRTs), such as green, oolong, and white teas, as well as caffeine have been proposed as tools for maintaining or enhancing energy expenditure and for increasing fat oxidation. Tea polyphenols have been proposed to counteract the decrease in metabolic rate that is usually present during weight loss. Their effects may be of particular importance during weight maintenance after weight loss. Although the thermogenic effect of CCRT has the potential to produce significant effects on these metabolic targets as well as on fat absorption and energy intake, possibly via its impact on the gut microbiota and gene expression, a clinically meaningful outcome also depends on compliance by the subjects. Limitations to this approach require further examination, including moderating factors such as genetic predisposition, habitual caffeine intake, and catechin composition and dose. Nevertheless, CCRTs may be useful agents that could help in preventing a positive energy balance and obesity.
Article
Different outcomes of the effect of catechin-caffeine mixtures and caffeine-only supplementation on energy expenditure and fat oxidation have been reported in short-term studies. Therefore, a meta-analysis was conducted to elucidate whether catechin-caffeine mixtures and caffeine-only supplementation indeed increase thermogenesis and fat oxidation. First, English-language studies measuring daily energy expenditure and fat oxidation by means of respiration chambers after catechin-caffeine mixtures and caffeine-only supplementation were identified through PubMed. Six articles encompassing a total of 18 different conditions fitted the inclusion criteria. Second, results were aggregated using random/mixed-effects models and expressed in terms of the mean difference in 24 h energy expenditure and fat oxidation between the treatment and placebo conditions. Finally, the influence of moderators such as BMI and dosage on the results was examined as well. The catechin-caffeine mixtures and caffeine-only supplementation increased energy expenditure significantly over 24 h (428.0 kJ (4.7%); P < 0.001 and 429.1 kJ (4.8%); P < 0.001, respectively). However, 24 h fat oxidation was only increased by catechin-caffeine mixtures (12.2 g (16.0%); P < 0.02 and 9.5 g (12.4%); P = 0.11, respectively). A dose-response effect on 24 h energy expenditure and fat oxidation occurred with a mean increase of 0.53 kJ mg(-1) (P < 0.01) and 0.02 g mg(-1) (P < 0.05) for catechin-caffeine mixtures and 0.44 kJ mg(-1) (P < 0.001) and 0.01 g mg(-1) (P < 0.05) for caffeine-only. In conclusion, catechin-caffeine mixtures or a caffeine-only supplementation stimulates daily energy expenditure dose-dependently by 0.4-0.5 kJ mg(-1) administered. Compared with placebo, daily fat-oxidation was only significantly increased after catechin-caffeine mixtures ingestion.
Article
A recently developed oral formulation in the form of coated tablets (Monoselect Camellia) (MonCam) containing highly bioavailable green tea extract (GreenSelect Phytosome) was tested in obese subjects (n=100) of both genders on a hypocaloric diet. Fifty subjects were assigned to the green tea extract plus hypocaloric diet, while the other 50 subjects followed the hypocaloric diet only. After 90 days of treatment, significant weight loss and decreased body mass index (BMI) were observed in the group taking the herbal extract (14-kg loss in the green tea group compared to a 5-kg loss in the diet-only group); waistline was reduced only in male subjects. Besides the effect on weight and BMI, biochemical parameters (LDL-, HDL-, and total cholesterol, triglycerides, growth hormone, insulin-like growth factor-1, insulin, and cortisol) were improved in both groups. Leptin, not tested in the diet-only group, was reduced in patients taking MonCam. Taking into consideration the high safety profile of the product and the total absence of adverse effects observed during and after the trial, MonCam appears to be a safe and effective tool for weight loss.