TerminatedNot Applicable

Metabolic Adaptations to High-fat Diet

Stopped: Feasibility of subjects completing the 3 day high fat diet protocol and multiple oral glucose tests

United States2 participantsStarted 2024-08-12

Plain-language 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

Who can participate

Age range

20 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males or Females between the ages of 20 and 45 years * Body mass index (BMI) of 18.5-29.9 kg/m2 * Low risk for medical complications as determined by physical activity readiness questionnaire (PARQ). * Low risk for food insecurity via the Hunger Vital Sign screener Exclusion Criteria: * Currently taking any antioxidant supplementation, prescription non-steroidal anti- inflammatory drugs, antibiotics, steroids, probiotics, medications for management of cholesterol, diabetes, body weight/obesity, or are undergoing transgender hormone therapy. * Currently pregnant (verified by urine pregnancy test) * Any history of disordered eating (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder, etc.) or high risk for disordered eating via validated questionnaire (SCOFF) * Any history of gastrointestinal diseases (i.e., gastroesophageal reflux disease, irritable bowel syndrome, Celiac disease, Crohn's disease, or lactose intolerance) * Allergies to wheat or gluten, milk, soy, tree nuts (e.g., almonds, walnuts, pecans), or peanuts. * Followed a ketogenic diet within the last three months * Instructed by a medical provided to avoid a high-fat diet due to cardiovascular disease risk. * Cardiorespiratory fitness (VO2max) greater than the 90th percentile for age and sex

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postprandial Metabolic Flexibility

Timeframe: 3 Days

Trial details

NCT IDNCT06537401

SponsorGeorge Washington University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

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