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Introduction: Type 1 diabetes mellitus (T1DM) patients are usually instructed to follow a low fat/high carbohydrate diet. A few studies in literature, however, reported metabolic benefits and sustainability of carbohydrate restricted diets. Case Report: Herein, we present a case of a 19-year-old male with newly diagnosed T1DM. The patient was first put on an insulin regime. Twenty days later, he shifted towards the paleolithic ketogenic diet and was able to discontinue insulin. Strict adherence to the diet resulted in normal glucose levels and a more than three-fold elevation of C-peptide level indicating restored insulin production. Currently, the patient is on the paleolithic ketogenic diet for 6.5 months. He is free of complaints, and no side effects emerged. Conclusion: We conclude that the paleolithic ketogenic diet was effective and safe in the management of this case of newly diagnosed T1DM. Marked increase in C peptide level within two months indicates that the paleolithic ketogenic diet may halt or reverse autoimmune processes destructing pancreatic beta cell function in T1DM.
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International Journal of Case Reports and Images, Vol. 5 No. 10, October 2014. ISSN – [0976-3198]
Int J Case Rep Images 2014;5(10):699–703.
www.ijcasereportsandimages.com
Tóth et al. 699
CASE REPORT OPEN ACCESS
Type 1 diabetes mellitus successfully managed with the
paleolithic ketogenic diet
Csaba Tóth, Zsófia Clemens
ABSTRACT
Introduction: Type 1 diabetes mellitus (T1DM)
patients are usually instructed to follow a low
fat/high carbohydrate diet. A few studies in
literature, however, reported metabolic benefits
and sustainability of carbohydrate restricted
diets. Case Report: Herein, we present a case
of a 19-year-old male with newly diagnosed
T1DM. The patient was first put on an insulin
regime. Twenty days later, he shifted towards
the paleolithic ketogenic diet and was able to
discontinue insulin. Strict adherence to the diet
resulted in normal glucose levels and a more than
three-fold elevation of C-peptide level indicating
restored insulin production. Currently, the
patient is on the paleolithic ketogenic diet for
6.5 months. He is free of complaints, and no
side effects emerged. Conclusion: We conclude
that the paleolithic ketogenic diet was effective
and safe in the management of this case of newly
diagnosed T1DM. Marked increase in C peptide
level within two months indicates that the
paleolithic ketogenic diet may halt or reverse
autoimmune processes destructing pancreatic
beta cell function in T1DM.
Keywords: Type 1 diabetes mellitus, Ketogenic
diet, Paleolithic-ketogenic diet, C-peptide,
Evolutionary medicine
Csaba Tóth1, Zsófia Clemens2
Affiliations: 1MD, Medical Director, Paleomedicina Hungary
Ltd, Evolutionary Medicine Working Group, Hidász u. 3,
H-1026, Budapest, Hungary; 2PhD, Senior Research Fellow,
Department of Neurology, University of Pécs, Rét u. 2,
H-7623, Pécs, Hungary.
Corresponding Author: Zsófia Clemens, Department of
Neurology, University of Pécs, Rét u. 2, H-7623, Pécs, Hungary.
Ph: 003672535900; Email: clemenszsofia@gmail.com
Received: 08 July 2014
Accepted: 31 July 2014
Published: 01 October 2014
How to cite this article
Tóth C, Clemens Z. Type 1 diabetes mellitus
successfully managed with the paleolithic ketogenic
diet. Int J Case Rep Images 2014;5(10):699–703.
doi:10.5348/ijcri-2014124-CR-10435
INTRODUCTION
Diabetic patients are, generally, recommended to
follow a diet that is low in fat and high in carbohydrates
[1]. Clinical studies, conversely, showed metabolic
benefits conferred by carbohydrate-restricted diets
including the ketogenic diet [2, 3] and the paleolithic
diet [4, 5] in type 2 diabetes. Much less data on the use
of low carbohydrate diets in type 1 diabetes (T1DM)
are available. Two studies by Nielsen et al. showed that
a low carbohydrate diet lowers the need for insulin as
well as the number of hypoglycemic episodes in T1DM
[6, 7]. It was also suggested that a low carbohydrate diet
is sustainable on the long-term [6, 7]. Ketogenic diets
have long been used in epilepsy [8]. There are three
cases in literature, where concurrent epilepsy and T1DM
were treated with the classical ketogenic diet and both
conditions improved [9–11]. Recently, we published
a case of childhood absence epilepsy where seizure
freedom was achieved using a modified ketogenic diet we
refer to as the paleolithic-ketogenic diet [12]. Herein, we
present a case of T1DM, where the same diet resulted in
remission of T1DM as assessed by normalization of blood
glucose levels and elevation in C-peptide level allowing
for discontinuation of external insulin replacement.
CASE REPORT
A 19-year-old male complained of increased thirst,
polyuria, itchy skin, malaise, and weight loss. The
symptoms were present for about two weeks prior to
International Journal of Case Reports and Images, Vol. 5 No. 10, October 2014. ISSN – [0976-3198]
Int J Case Rep Images 2014;55(10):699–703.
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Tóth et al. 700
diagnosis. On November 24, 2013 self monitoring of
blood glucose showed 384 mg/dL. Previous medical
history was unremarkable. Anamnestic data included
consuming of muscle boosting protein through a month
prior to symptom onset. Laboratory assessment on
November 25, 2013 (Table 1) showed elevations in glucose
(218 mg/dL) and HbA1c (9.2%). Testing for glutamic acid
decarboxylase (GAD) antibodies showed positivity
(52 U/mL; normal range 0–10 U/mL) and mild positivity
for pancreatic islet cell autoantibodies (ICAs). C-peptide
level was not measured at this time. He was diagnosed
with T1DM. He was put on insulin replacement therapy
(38 IU of insulin) and standard conventional diabetes
diet with six meals containing 240 grams carbohydrate
daily. He followed this regime for 20 days. While on this
regime his glucose levels fluctuated between 68–267
mg/dL (Figure 1).
Carbohydrate he consuming before was less than 240
grams. Since his malaise did not improve the patient
consulted the first author in December 2013. To ascertain
T1DM laboratory examination of C-peptide was carried
out. C-peptide level of 0.6 ng/mL measured on January
08, 2014 indicated subnormal insulin secretion (Figure
2). The patient was suggested to switch to the paleolithic-
ketogenic diet which he initiated on December 21, 2013.
From this time, he was also taking 5,000 IU of vitamin
D3 but nothing else as supplement. His diet consisted
of meat, organ meat, fat and eggs. In his diet, red and
fat meats dominated over lean meats. He was eating
vegetables in insignificant amounts. His diet had a
ketogenic ratio (fat : protein + carbohydrate) of at least
2:1. No oil of plant origin or artificial sweeteners were
allowed. The patient was under our close control and
reported daily food records and blood glucose levels.
Upon shifting toward the paleolithic ketogenic diet
glucose levels returned to normal and no major elevations
were seen postprandially either. Insulin was therefore
discontinued. The tapering of insulin was done promptly:
following the first paleolithic-ketogenic meal glucose level
was only 86 mg/dL thus there was no need for external
insulin. Similar blood glucose levels were measured on
subsequent meals on the diet. Thus, the patient required
no insulin subsequently either. Home glucose monitoring
was carried out preprandially as well as postprandially
and tracked once a day for consecutive meals (that is on
consecutive days measures were taken for breakfast, lunch
and dinner, respectively). Average blood glucose level
while on the standard diabetes diet with insulin was 119
mg/dL while 85 mg/dL on the paleolithic-ketogenic diet
without insulin. Fluctuations in glucose levels decreased
as indicated by a reduction of standard deviation values
from 47 mg/dL on the standard diabetes diet to 9 mg/dL
on the paleolithic-ketogenic diet. Average postprandial
glucose elevation on the standard diabetes diet was 23
mg/dL while only 5.4 mg/dL on the paleolithic-ketogenic
diet (Figure 1).
C-peptide measurement was repeated on the 10th
week of the diet (on March 06, 2014). This indicated
an elevation to a value of 2.2 ng/mL (Figure 2). A
comprehensive laboratory workup carried out on March
14, 2014 indicated normal laboratory parameters with
the exception of total cholesterol and LDL cholesterol
which were slightly elevated. Glucose level was 88 mg/
dL while HbA1c was 5.5% (for all laboratory values see
Table 1). Urinary ketone was positive. On March 21, 2014
antibody testing for ICA showed no change in the mild
Table 1: Laboratory data at the time of diagnosis on a normal diet
(on November 25, 2013) and at 10 weeks after diet initiation,
on the paleolithic-ketogenic diet without insulin (on March 14,
2014). Note the normal level of glucose, HbA1c and low level
of triglyceride while on the paleolithic-ketogenic diet. Dashes
indicate that the given parameter was not measured.
Normal diet Paleolithic-ketogenic diet
WBC 5.9 5.4 G/l
RBC 5.7 5.3 T/l
Hemoglobin 16 15.2 G/dL
Hematocrit 48 45 %
Iron 136.3 98.9 µg/ dL
Thrombocyte 230 150 G/l
Sodium 134 139 mEq/l
Potassium 3.9 3.8 mEq/l
Calcium 9.52 10 mg/dL
Magnesium 2.02 mg/dL
Carbamide 10.6 14.8 mg/dL
Creatinine 0.88 0.97 mg/dL
eGFR >90 >90
Glucose 218 88 mg/dL
Hb1Ac 9.2 5.5 %
Total cholesterol 143 301 mg/dL
HDL cholesterol 54.8 mg/dL
LDL cholesterol 224 mg/dL
Triglyceride 168 111 mg/dL
Uric acid 6.12 mg/dL
GOT 31 19 U/l
GPT 44 18 U/l
GGT 17 16 U/l
Total bilirubin 0.94 mg/dL
TSH 3.53 mIU/l
CRP 1.1 mg/L
Abbreviations: WBC - white blood cell count, RBC - red blood
cell count, eGFR - estimated glomerular filtration rate, HbA1c -
glycated hemoglobin, HDL - high density lipoprotein, LDL - low
density lipoprotein, TSH - thyroid stimulating hormone, CRP
- C-reactive protein
International Journal of Case Reports and Images, Vol. 5 No. 10, October 2014. ISSN – [0976-3198]
Int J Case Rep Images 2014;55(10):699–703.
www.ijcasereportsandimages.com
Tóth et al. 701
positivity measured before and some elevation in GAD
antibodies (86 U/mL). At the time of writing this case
report, the patient is on the paleolithic ketogenic diet for
6.5 months and still exhibit low glucose levels. No side
effects emerged and he is completely free of symptoms.
The patient gave written informed consent for writing
this case study.
DISCUSSION
This is a first report of T1DM being successfully
managed with the paleolithic-ketogenic diet. In literature,
a few studies are available on the use of carbohydrate
restricted diet in the treatment of T1DM [6, 7]. Low
carbohydrate diet in these studies resulted in reduced
number of hypoglycemic episodes and also lowered
the need for insulin. In our case, however, insulin
replacement was not just reduced but could be stopped.
Importantly, insulin discontinuation was paralleled by
a marked increase in C peptide level indicating restored
pancreatic insulin production.
Shortly before diabetes onset our patient consumed
muscle boosting protein which contained bovine milk
protein. Consumption of cow’s milk has repeatedly been
shown to increase risk of T1DM [13, 14]. It is suggested
that bovine milk protein may promote autoimmune
processes giving rise to T1DM [15]. Also in two case
reports from literature, where epilepsy was treated
with the classical ketogenic diet, which contains large
amount of dairy, T1DM developed subsequently [9, 11].
A major difference between the classical ketogenic diet
and the paleolithic ketogenic diet is that milk and dairy
are excluded in the latter. We suggest that the paleolithic
ketogenic diet not only normalize glucose levels but
may also halt autoimmune processes mediated by non-
paleolithic substances including milk protein [16].
While on the paleolithic-ketogenic diet glucose levels
remained low both during preprandially and postprandially.
Follow-up laboratory assessment indicated laboratory
parameters remaining in the normal range except for
elevations in total cholesterol and LDL cholesterol. In fact,
these elevations are expected on a diet rich in animal fat
and cholesterol and were also reported in studies with the
classical ketogenic diet [17] as well as in our previous case
of childhood absence epilepsy treated with the paleolithic
ketogenic diet [12]. Moreover, it is now acknowledged that
neither dietary nor serum cholesterol represent a risk factor
for cardiovascular disease [18]. On follow-up antibody
testing ICA remained mildly positive while GAD antibodies
elevated to some extent. Although these parameters are
frequently associated with T1DM they do not seem to be
specific nor indicate progression of disease [19].
Type 1 diabetes mellitus is considered as a lifelong
metabolic condition due to the exhaustion of insulin-
secretory cells of the pancreas. Therefore, T1DM is
generally believed to be untreatable by any diet. There
are indications, however, that residual pancreatic beta
cell functioning may extend well beyond the time of
diagnosis [20]. Nevertheless C-peptide levels decrease
monotonically through years after diagnosis [20]. We are
not aware of any data from literature indicating elevation
of C-peptide resulting from a dietary intervention. A
recent case study of a child with T1DM reported remission
without insulin on gluten-free diet [21]. However, in that
case C-peptide continued to decline while on the gluten-
free diet.
Figure 1: Blood glucose levels while on the standard diabetes
diet containing 240 g carbohydrate with insulin therapy and
while on the paleolithic-ketogenic diet without insulin. Glucose
was measured preprandially and postprandially once a day for
consecutive meals (that is on consecutive days measures were
taken for breakfast, lunch and dinner, respectively). Note low
glucose levels and the absence of major postprandial elevations
while on the paleolithic ketogenic diet. Due to stable glucose
levels through five months, from May 15, 2014 the patient
switched to self-monitoring his glucose levels only once a week.
Figure 2: C-peptide levels shortly after diet initiation (on the
18th day of the paleolithic ketogenic diet) and two months later.
Note the more than three-fold increase in C-peptide within two
months.
International Journal of Case Reports and Images, Vol. 5 No. 10, October 2014. ISSN – [0976-3198]
Int J Case Rep Images 2014;55(10):699–703.
www.ijcasereportsandimages.com
Tóth et al. 702
In the standard care of T1DM insulin is a cornerstone.
It is important to emphasize that the paleolithic-
ketogenic diet as a standalone therapy may be applied
only in those cases with residual insulin secretion. In
cases with no internal insulin secretion the paleolithic-
ketogenic therapy may be only used as an adjunct to
insulin replacement.
CONCLUSION
We suggest that an intervention with the paleolithic
ketogenic diet in an early stage of the disease with residual
insulin secretion may halt or reverse type 1 diabetes
mellitus (T1DM). Follow-up at sixth month in the case of
our patient is relatively short and the positive results may
appear as a honeymoon effect. However, this term is used
in relation to the beginning of insulin therapy not the end
of it. We believe that with normalized insulin secretion
and a further adherence to the diet the patient may be
managed on the long-term.
*********
Author Contributions
Tóth Csaba – Substantial contributions to conception and
design, Acquisition of data, Analysis and interpretation
of data, Drafting the article, Revising it critically for
important intellectual content, Final approval of the
version to be published
Zsófia Clemens – Substantial contributions to
conception and design, Acquisition of data, Analysis
and interpretation of data, Drafting the article, Revising
it critically for important intellectual content, Final
approval of the version to be published
Guarantor
The corresponding author is the guarantor of submission.
Conflict of Interest
Authors declare no conflict of interest.
Copyright
© 2014 Tóth Csaba et al. This article is distributed
under the terms of Creative Commons Attribution
License which permits unrestricted use, distribution
and reproduction in any medium provided the original
author(s) and original publisher are properly credited.
Please see the copyright policy on the journal website for
more information.
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ABOUT THE AUTHORS
Article citation: Tóth C, Clemens Z. Type 1 diabetes mellitus successfully managed with the paleolithic ketogenic
diet. Int J Case Rep Images 2014;5(10):699–703.
Csaba Tóth is General Practitioner from Hungary with 20 years experience in intensive care medicine,
internal medicine and family medicine. He is using the paleolithic-ketogenic nutrition in the treatment
of chronic medical illnesses including diabetes, cancer, autoimmune diseases and epilepsy for ve
years. He is operating private practice in Budapest and in a few other cities in Hungary. In 2013, he
organized a course on evolutionary medicine in the mandatory training of GPs at the University of
Szeged, Hungary. With an evolutionary medical attitude he strives for the full recovery of his patients.
Email: csaba@paleomedicina.com
Zsóa Clemens is Biologist and clinical researcher specialized in nutrition, nutritional therapy and
brain research. She earned her PhD in electroencephalograpy of sleep and epilepsy from Semmelweis
University, Budapest, Hungary in 2005. Currently, she is Senior Research Fellow at the Neurological
Department, University of Pécs, Hungary and is also afliated with the Evolutionary Medicine Working
Group of Paleomedicina Hungary Ltd. In international academic journals, she has published 29 research
articles with more than 500 citations. Email: clemenszsoa@gmail.com
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... This is an animal fat-meat based diet similar to that originally proposed and used by gastroenterologist Voegtlin (13). To date we have published eight cases including patients with epilepsy (14,15), type 1 diabetes (16,17), metabolic syndrome (18), Gilbert's syndrome (19), Crohn's disease (20) and soft palate cancer (21) successfully treated with the paleolithic ketogenic diet. Importantly, the classic version of the ketogenic diet is known to be associated with low magnesium levels (22) one of the most well-known side-effects of the classic ketogenic diet. ...
... Importantly, the classic version of the ketogenic diet is known to be associated with low magnesium levels (22) one of the most well-known side-effects of the classic ketogenic diet. Our published cases (14)(15)(16)(17)(18)(19)(20)(21), along with our general experience, however, indicate that magnesium levels are normal on the paleolithic ketogenic diet. In order to quantify this clinical observation we performed a study in which we retrospectively assessed magnesium levels in relation to glycemic parameters in 45 patients with various diseases and five healthy subjects on the paleolithic ketogenic diet. ...
... were low. A similar pattern of laboratory parameters was seen in our previous case studies with the paleolithic ketogenic diet (14)(15)(16)(17)(18)(19)(20)(21) and may be regarded as indicating adequate dietary adherence. ...
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The immune system is an efficiently toned machinery that discriminates between friends and foes for achieving both host defense and homeostasis. Deviation of immune recognition from foreign to self and/or long-lasting inflammatory responses results in the breakdown of tolerance. Meanwhile, educating the immune system and developing immunological memory are crucial for mounting defensive immune responses while protecting against autoimmunity. Still to elucidate is how diverse environmental factors could shape autoimmunity. The emergence of a world pandemic such as SARS-CoV-2 (COVID-19) not only threatens the more vulnerable individuals including those with autoimmune conditions but also promotes an unprecedented shift in people’s dietary approaches while urging for extraordinary hygiene measures that likely contribute to the development or exacerbation of autoimmunity. Thus, there is an urgent need to understand how environmental factors modulate systemic autoimmunity to better mitigate the incidence and or severity of COVID-19 among the more vulnerable populations. Here, we discuss the effects of diet (macronutrients and micronutrients) and hygiene (the use of disinfectants) on autoimmunity with a focus on systemic lupus erythematosus.
... The child's daily average dosages of basal and rapid-acting insulin were reduced from 3.8 to 0.4 units, and from 1.4 to 0.7 units, respectively, with the use of a VLCD. Authors of another two studies suggested that, with the use of the palaeolithic-ketogenic diet, it was possible to completely withdraw insulin by extending the 'honeymoon period' (when the pancreas is still able to produce some insulin after blood sugar levels become nearly normal) (Tóth and Clemens, 2014;. Although no specific diet for people with diabetes exists, avoiding refined sugar and processed foods, and lowering carbohydrate intake, have been shown to be an excellent alternative to intensive insulin therapy. ...
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Type 1 diabetes mellitus is a serious autoimmune disease for which no cure is available. The treatment includes insulin therapy, carbohydrate counting, eating healthy foods, exercising regularly, and maintaining a healthy weight. The goal is to keep blood glucose levels close to normal most of the time to delay or prevent complications. Despite the increase in the use of insulin pumps and continuous glucose monitors in recent years, the management of type 1 diabetes remains suboptimal in terms of glycaemic control and normal glycated haemoglobin (HbA1c) level. This article discusses the case of a child with type 1 diabetes who was successfully treated with a very low-carbohydrate diet, resulting in normal levels of HbA1c and normal blood glucose 95% of the time in a range of 70–180 mg/dL (4.0 mmol/L−10 mmol/L). Therefore, further studies are needed to verify how a very low carbohydrate diet impacts child development.
... In contrast, in an observational study on 11 adult patients with T1D who followed a KD (<55 g of carbohydrates), the KD was associated with good HbA1c levels and reduced glucose variability, but also with dyslipidemia and an increased frequency of hypoglycemic events [94]. In the case report by Toth C. et al. [95], ketogenic paleolithic diet was proposed in a 19-years-old male with newly diagnosed T1DM and resulted in normalization of glucose levels, increased C-peptide levels and increased triglycerides and LDL cholesterol. It is worth to note that in this case report there is no mention about ketone bodies level range; moreover, C-peptide level increase was documented only 2 months after diagnosis, when it is not so uncommon to observe a rise in C-peptide levels (honeymoon phase) [96]. ...
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Low-carb and ketogenic diets are popular among clinicians and patients, but the appropriateness of reducing carbohydrates intake in obese patients and in patients with diabetes is still debated. Studies in the literature are indeed controversial, possibly because these diets are generally poorly defined; this, together with the intrinsic complexity of dietary interventions, makes it difficult to compare results from different studies. Despite the evidence that reducing carbohydrates intake lowers body weight and, in patients with type 2 diabetes, improves glucose control, few data are available about sustainability, safety and efficacy in the long-term. In this review we explored the possible role of low-carb and ketogenic diets in the pathogenesis and management of type 2 diabetes and obesity. Furthermore, we also reviewed evidence of carbohydrates restriction in both pathogenesis of type 1 diabetes, through gut microbiota modification, and treatment of type 1 diabetes, addressing the legitimate concerns about the use of such diets in patients who are ketosis-prone and often have not completed their growth.
... Previously we have published a case of soft palate cancer halted by the paleolithic ketogenic diet for 20 months [10]. We also reported successful management of cases of autoimmune conditions including type 1 diabetes [24,25] and cases with epilepsy [26,27] and metabolic syndrome [28] using the paleolithic ketogenic diet. In another case study we reported that a full dietary adherence is needed to halt disease progression in rectal cancer [29]. ...
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Autoimmune diseases are complex conditions that are increasing in incidence worldwide. Autoimmune disorders are often associated clinical challenges in regards to clear diagnoses, comorbidities, and effective disease management and treatment strategies. Importantly, research suggests that an individual’s nutritional status and metabolic health, such as the presence of obesity or metabolic syndrome, may play a role in the risk, pathophysiology, and management of autoimmune diseases. Further, adherence to Western or Mediterranean-style dietary patterns, as well as intake of specific macronutrients (e.g., carbohydrates, protein, fatty acids), micronutrients (e.g., vitamin D, selenium, sodium) and non-nutrient dietary factors (e.g., food contaminants, gut microbiome profiles), may modulate autoimmune disease development and complications. Thus, nutritional interventions may represent an effective approach to mitigate risk and support the management of autoimmune disorders.
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The very-high-fat ketogenic diet can worsen lipid levels in children with pre-existing hyperlipidemia by increasing serum lipoproteins and reducing antiatherogenic high-density lipoproteins. A retrospective chart review of 160 children treated with the ketogenic diet from September 2000 to May 2011 was performed. Twelve children with pre-existing hyperlipidemia were identified. Lipid levels including total cholesterol, low-density lipoprotein, triglycerides, high-density lipoprotein, and total cholesterol/high-density lipoprotein were measured pre-diet and at 3, 6, and 12 months of treatment. During treatment, there was a significant reduction in mean total cholesterol, low-density lipoprotein, and total cholesterol/high-density lipoprotein. Total cholesterol and low-density lipoprotein were normalized in 8 and 7 children at 6 months; and 9 and 9 children at 12 months respectively. At 6 and 12 months, tot cholesterol/HDL ratio was normalized in 5 and 7 children respectively. Diet modifications were made to achieve healthy lipid levels. By extrapolating the data, it suggests lipid levels can be controlled in children and adults with ketogenic diet treatment.
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Dietary cholesterol comes exclusively from animal sources, thus it is naturally present in our diet and tissues. It is an important component of cell membranes and a precursor of bile acids, steroid hormones and vitamin D. Contrary to phytosterols (originated from plants), cholesterol is synthesised in the human body in order to maintain a stable pool when dietary intake is low. Given the necessity for cholesterol, very effective intestinal uptake mechanisms and enterohepatic bile acid and cholesterol reabsorption cycles exist; conversely, phytosterols are poorly absorbed and, indeed, rapidly excreted. Dietary cholesterol content does not significantly influence plasma cholesterol values, which are regulated by different genetic and nutritional factors that influence cholesterol absorption or synthesis. Some subjects are hyper-absorbers and others are hyper-responders, which implies new therapeutic issues. Epidemiological data do not support a link between dietary cholesterol and CVD. Recent biological data concerning the effect of dietary cholesterol on LDL receptor-related protein may explain the complexity of the effect of cholesterol on CVD risk.