Clinical trial NCT06537401: Metabolic Adaptations to High-fat Diet
Official title: Adaptations in Postprandial Metabolic Flexibility Following a Three-day, High-fat Diet
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adiposity
Insulin Sensitivity
Impaired Glucose Tolerance
Metabolic Disturbance
Keywords: Metabolism
Feeding
Substrate Oxidation
Metabolic Flexibility
High Fat Diet
Insulin Sensitivity
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-Randomized Crossover
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Postprandial Metabolic Flexibility
timeFrame: 3 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: George Washington University
name: Matthew D Barberio, PhD
role: PRINCIPAL_INVESTIGATOR
References: