High-Fat Diet for Insulin Resistance

(MetFlexHFD Trial)

Overseen By Nicholas A Foreman, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Must not be taking: Antioxidants, NSAIDs, Antibiotics, others

Disqualifiers: Pregnancy, Eating disorders, Gastrointestinal diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Matthew D Barberio, PhD

Principal Investigator

George Washington University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 20-45 with a BMI of 18.5-29.9, who are at low risk for medical complications and food insecurity. It's not suitable for those outside this age range or BMI, or those at higher risk based on specific health screenings.

Inclusion Criteria

I am considered low risk for complications based on a health questionnaire.

My BMI is between 18.5 and 29.9.

I am at low risk for not having enough food according to a screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Intervention

Participants consume a high-fat diet to decrease insulin sensitivity

3 days

Participants track diet using a mobile application

Metabolic Testing

Whole-body metabolism is measured during a standard 75-gram oral glucose tolerance test

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hypercaloric, High Fat Diet

Trial Overview The study tests how a high-fat diet over three days affects the body's response to sugar and insulin during an oral glucose tolerance test. Participants will undergo metabolic measurements before and after the diet to see how reduced insulin sensitivity impacts metabolism.

How Is the Trial Designed?

Group I: Hypercaloric, High Fat Diet Experimental Treatment 1 Intervention

For three calendar days participants will be asked to track all foods they eat and beverages they drink (habitual diet) in a mobile application. Following the three days following the habitual diet, participants will consume 165% of their estimated daily energy needs with 65% of those calories coming from fat.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+