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Effect of Diet Induced Ketosis on LDL Turnover Rates

NCT05103761 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-11-09

No results posted yet for this study

Summary

There have been concerning case reports of marked elevations of LDL-c in some individuals consuming a KD and Dr. Lewis has been referred a number of these cases to his lipid clinic, some of whom have had extreme elevations of LDL that mimic familial hypercholesterolemia. These marked elevations of LDLc are unique to a ketogenic diet and far exceed the typical mild elevations seen in those consuming a high fat, low carbohydrate LGIT. The degree of elevation of LDL-c suggests that ketosis per se may impair LDL receptor-mediated LDL particle clearance. This clinical observation is a concerning and clinically important issue since millions of people are consuming this popular diet. There are currently no studies that have examined the mechanism of the LDL-raising effect of a ketogenic diet.

Conditions

  • Ketosis, Metabolic

Interventions

OTHER

Study diet

A low carbohydrate diet (\<20g/day) is administered to achieve diet-induced ketosis.

OTHER

Low glycemic index treatment diet

A diet matched with the study diet with added carbohydrates (40-60g/day) to avoid ketosis.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Gary F Lewis, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103761 on ClinicalTrials.gov