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Completed

NCT Number: NCT07633704

Protective Effect of Exercise on Acute High-fat Overfeeding

Metabolic flexibility is the ability to switch rapidly from one substrate (i.e. fuel source) to another (e.g. fats to carbohydrates) in response to ingested foods. Worse metabolic flexibility is linked to worse metabolic outcomes, but exercise is thought to be protective against nutrient excess. We will conduct a standard oral glucose tolerance test (OGTT) to assess insulin resistance and metabolic flexibility. Participants will be randomized to a 24-hour hypercaloric, high-fat diet (HFD) with and without an exercise bout. During the hypercaloric HFD, participants will eat extra calories with more calories from fat than normal, which is expected to increase insulin resistance. After each arm of the high-fat diet, we will repeat the OGTT. During each OGTT, expired gases will be analyzed noninvasively to determine metablic flexibility. Insulin resistance will be determined with blood drawn during each OGTT. By comparing metabolic flexiblity and insulin resistance before and after the normal diet and after the high-fat diet intervention, a better understanding of how insulin resistance affects metabolism and how exercise can be protective will be developed.

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Key information

Conditions

Insulin Sensitivity/Resistance Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Milken Institute School of Public Health

Washington D.C., District of Columbia, 20052, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females between the ages of 20 and 40 years
  • A body mass index (BMI) of 20.0 - 29.9 kg/m2.
  • Low risk for risk of injury or health complications as determined by physical activity readiness questionnaire (PARQ).

Exclusion criteria

  • Are currently taking any antioxidant supplementation (daily multivitamin not included), prescribed non-steroidal anti-inflammatory drugs (NSAIDS), antibiotics, steroids, or probiotics.
  • Are currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing hormone therapy.
  • Are unwilling or unable to comply with study procedures, at the discretion of the investigators.
  • Are unwilling to have biospecimens (blood and urine) collected and stored (only blood) for future research.
  • Pregnant women - A urine pregnancy test will be conducted prior to any testing procedures.
  • A history of disordered eating, including anorexia nervosa, bulimia nervosa, binge eating disorder, or avoidant restrictive food intake disorder or deemed high-risk for disordered eating via questionnaire.
  • A history of gastrointestinal diseases, such as galactosemia, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), Celiac disease, Crohn's disease, or lactose intolerance.
  • Individuals with known allergies to wheat or gluten, milk, soy, tree nuts (e.g., almonds, walnuts, pecans), or peanuts.
  • Deemed high risk for food insecurity via the Hunger Vital Sign screener.
  • Have followed a ketogenic diet within the last three months or have been told to avoid a high-fat diet by a medical provider for risk of cardiovascular disease.
  • Cardiorespiratory fitness (VO2max) below the 30th percentile for age and sex (measured at initial screening visit)

Treatment and study plan

High Fat Overfeeding

Behavioral

Caloric intake 180% of daily caloric need with 65% from fat

High Fat Overfeeding + Exercise

Behavioral

Caloric intake 180% of daily caloric need with 65% from fat with acute moderate exercise (energy expenditure ~25% of daily caloric need).

Primary outcomes

  1. Insulin Sensitivity via Oral Glucose Insulin Sensitivity Index

    Time frame: Immediately following high fat diet intervention

    Oral Glucose Insulin Sensitivity

Secondary outcomes

  1. Metabolic Flexibility (Respiratory Exchange Ratio) via Indirect Calorimetry

    Time frame: Immediately following high fat diet intervention

    Respiratory Exchange Ratio, Glucose Oxidation, Fatty Acid Oxidation

  2. Carotid Femoral Pulse Wave velocity

    Time frame: Immediately following high fat diet intervention

    Carotid Femoral Pulse Wave Velcoity

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Acronym: HFDEXC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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