Protective Effect of Exercise on Acute High-fat Overfeeding

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT07633704
Status
Completed

Conditions

  • Insulin Sensitivity/Resistance

Eligibility Criteria

Sex
ALL
Age
20 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Feb 10, 2025
Status verified
Apr 2026
Primary completion
Apr 7, 2026
Completion
Apr 9, 2026

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: High Fat Overfeeding
    Resting metabolic rate will be used estimate total caloric need. We will use this estimate to create a daily target calorie intake and target fat intake for the High-Fat Diets (HFD) in the study. During the high-fat diet, subjects will eat 80% more calories than necessary with at least 65% of the calories coming from fat for one day.
  • Experimental: High Fat Overfeeding + Exercise
    On the day of High Fat Overfeeding (See High Fat Overfeeding arm description), subjects will complete a single bout of exercise. The duration of exercise will be individualized to \~25% of daily energy needs.The intensity of exercise will be individualized to be at a low intensity in the moderate domain. Extra foods will be provided to match energy balance across the high-fat overfeeding days

Primary Outcome Measure

Insulin Sensitivity via Oral Glucose Insulin Sensitivity Index [ Time Frame: Immediately following high fat diet intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Milken Institute School of Public HealthWashington D.C.District of Columbia20052-

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Milken Institute School of Public Health· Washington D.C., DC

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