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Metabolic Adaptations to High-fat Diet

NCT06537401 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-08-26

No results posted yet for this study

Summary

The purpose of this study is to understand how the body's response after a meal is influenced by insulin and sugar in the blood. The primary question this study seeks to address is what is the effect of reduced insulin sensitivity on postprandial metabolic flexibility to an oral glucose tolerance test. We will recruit 50 adults (ages 20-45; 50% female) who are otherwise healthy (no known clinical diagnosis) into our non-randomized crossover trial to determine the effect of changes in insulin sensitivity on metabolic response to feeding. Insulin sensitivity will be decreased using a three-day high-fat diet (HFD) with extra calories. Whole-body metabolism will be measured during a standard 75-gram oral glucose tolerance test (OGTT). Metabolic response to feeding (e.g. OGTT) will be compared before and after the HFD and compared with the control diet to understand the effect of decreased insulin sensitivity on the metabolic response to feeding. The role of biological sex as a moderator of the effect of increased insulin resistance on postprandial metabolic flexibility will also be investigated

Conditions

  • Adiposity
  • Insulin Sensitivity
  • Impaired Glucose Tolerance
  • Metabolic Disturbance

Interventions

BEHAVIORAL

Hypercaloric, High Fat Diet

Participants will select meals from a list of sample breakfast, lunch, and dinner options from grocery stores. Typical intake will be estimated as 160-170% of resting metabolic rate, which will then be multiplied by 1.65 as the target calorie intake for the HFD. Target fat intake will be 65% of the HFD calorie target. To ensure participants will achieve the desired calorie and fat intake, they will also be provided with pre-made nutrient shakes and half-and-half. Participants will supplement their food intake with one to three shakes per day for each of the three days, depending on the fat and calorie content of the foods they select. They will be asked to add half-and-half equally between across the shakes.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Principal Investigators

  • Matthew D Barberio, PhD · George Washington University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT06537401 on ClinicalTrials.gov