Examining the Efficacy of a Very-Low-Carbohydrate Ketogenic Diet on Cardiovascular Health in Adults with Mildly Elevated Low-Density Lipoprotein Cholesterol in an Open-Label Pilot Study

Nikolaos Tzenios, Erin D Lewis, David C Crowley, Mohamad Chahine, Malkanthi Evans, Nikolaos Tzenios, Erin D Lewis, David C Crowley, Mohamad Chahine, Malkanthi Evans

Abstract

Background: The objective of this open-label pilot study was to investigate the efficacy of a very-low-carbohydrate ketogenic diet (VLCKD), known as Nic's Ketogenic Diet, for 140 days on cardiometabolic markers in healthy adults with mildly elevated low-density lipoprotein cholesterol (LDL-C). Methods: Study assessments were conducted at Day 0, 28, 56, 70, 84, 112, and 140, and weight and blood pressure (BP) were measured and fasting blood was collected for analysis of plasma lipids. A DEXA scan was performed and body mass index recorded on Day 0, 70, and 140. Blood glucose, inflammatory, and thyroid markers were measured on Day 0 and 140. Compliance was assessed using weekly 3-day food records and daily blood glucose and ketone monitoring. Results: The results showed that body fat percentage decreased by 2.25% and 4.41% at Day 70 and 140, respectively (P ≤ 0.012). Significant reductions in android, gynoid, and android/gynoid fat ratio and increases in muscle mass occurred by Day 70 and 140. Total cholesterol, LDL-C, and high-density lipoprotein cholesterol were increased and systolic BP and glycated hemoglobin (HbA1c) were decreased at Day 140 (P < 0.05). Following this VLCKD for 140 days was found to be safe and was well tolerated. Conclusion: The VLCKD showed beneficial changes in body composition and cardiometabolic markers in eutrophic and overweight participants in a 140-day study suggesting a future role for this diet in populations at cardiovascular disease risk. Future research with larger sample size in a randomized double blind clinical trial is warranted to confirm these results. Clinical Trial Registration number: NCT04195594.

Keywords: body composition; cardiovascular disease; cholesterol; ketogenic diet; lipid profile; weight loss.

Conflict of interest statement

N.T. is an executive at TRCGEN+, London SW6 1JA, England, United Kingdom. N.T. is the main creator of Nic's Ketogenic Diet. E.D.L., D.C.C., and M.E. are employees of KGK Science and have no conflicts of interest. M.C. has no conflict of interest.

Figures

FIG. 1.
FIG. 1.
Disposition of study participants.
FIG. 2.
FIG. 2.
Mean total body, android, and gynoid fat percentage (A) and muscle mass percentage (B) of participants at baseline and Day 70 and 140 of following a VLCKD. * indicates significant change from baseline (P < 0.05). VLCKD, very-low-carbohydrate ketogenic diet.
FIG. 3.
FIG. 3.
Mean body weight from baseline to Day 140 of participants following a VLCKD. Values presented as mean ± SEM; * indicates P < 0.001. SEM, standard error of the mean.
FIG. 4.
FIG. 4.
Mean TC (A), LDL-C (B), HDL-C (C), TC/HDL-C ratio (D), triglycerides (E), and triglyceride/HDL-C ratio (F) from baseline to Day 140 of participants following a VLCKD. Values presented as mean ± SEM; * indicates P < 0.05. HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; TC, total cholesterol.
FIG. 5.
FIG. 5.
Mean systolic (A) and diastolic (B) blood pressure from baseline to Day 140 of participants following a VLCKD. Values presented as mean ± SEM; * indicates P < 0.05.

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Source: PubMed

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