Ketogenic Diet in Healthy Adults With Differing BMI

NCT06515912 | Completed

• 1 other identifier: KTO
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are:

• Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity?
• Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity? Participants will:
• Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
• Visit the metabolic kitchen daily (Monday-Friday) to pick up meals
• Attend 5 fasting visits at the Clinical Research Center for testing

Conditions

Cardiovascular Diseases

Keywords

Ketogenic Diet

Outcome Measures

Primary Outcomes (1)

• LDL-cholesterol concentration change from baseline

  Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. Change in LDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).

  4 weeks

Secondary Outcomes (23)

• Endothelial function - Flow Mediated Dilation (FMD) change from baseline

  4 weeks

• Triglycerides concentration change from baseline

  4 weeks

• Total cholesterol concentration change from baseline

  4 weeks

• HDL-cholesterol concentration change from baseline

  4 weeks

• Concentration of LDL and triglyceride-rich lipoprotein subparticles change from baseline

  4 weeks

Other Outcomes (1)

• Composition of the gut microbiota

  Baseline, 4 weeks

Study Arms (2)

Low BMI

EXPERIMENTAL

BMI 18.5 - 22 kg/m\^2 Intervention: Ketogenic diet 28 days

Other: Ketogenic Diet

High BMI

ACTIVE COMPARATOR

BMI 30-35 kg/m\^2 Intervention: Ketogenic diet 28 days

Other: Ketogenic Diet

Interventions

Ketogenic Diet OTHER

A ketogenic diet with 5% carbohydrate, 18% protein, and 77% fat by percent kcal.

High BMI; Low BMI

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-45 years
• Fasting direct LDL-C ≤100 mg/dL
• BMI of 18.5-22 kg/m2 or 30-35 kg/m2
• Blood pressure \<140/90 mmHg
• Fasting blood glucose \<126 mg/dL
• Fasting triglycerides \<350 mg/dL
• ≤10% change in body weight for 6 months prior to enrollment

You may not qualify if:

• Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
• Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs
• Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
• Diagnosed liver, kidney, or autoimmune disease
• Prior cardiovascular event (e.g., stroke, heart attack)
• Current pregnancy or intention of pregnancy within the next 2 months
• Lactation within prior 6 months
• Follows a vegetarian or vegan diet
• Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
• Antibiotic use within the prior 1 month
• Oral steroid use within the prior 1 month
• Use of tobacco or nicotine containing products within the past 6 months
• Cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
• Participation in another clinical trial within 30 days of baseline
• Currently following a restricted or weight loss diet

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 23, 2024
• Study Start: January 29, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication of all pre-specified primary and secondary outcomes

Locations

US (1)