Insulin Sensitivity/ResistanceHFDEXCNCT07633704
Protective Effect of Exercise on Acute High-fat Overfeeding
A study testing High Fat Overfeeding and High Fat Overfeeding + Exercise in people with Insulin Sensitivity/Resistance, run by George Washington University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity/Resistance
- What is being tested?
- High Fat Overfeeding and High Fat Overfeeding + Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Milken Institute School of Public Health
Washington D.C., District of Columbia, 20052
About this study
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.
- Conditions
- Insulin Sensitivity/Resistance
- Being tested
- High Fat Overfeeding, High Fat Overfeeding + Exercise
- Keywords
- Metabolism, Exercise, Substrate Oxidation, Overfeeding, High Fat Diet
- Medical subject headings
- Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fat OverfeedingBehavioural
Caloric intake 180% of daily caloric need with 65% from fat
High Fat Overfeeding + ExerciseBehavioural
Caloric intake 180% of daily caloric need with 65% from fat with acute moderate exercise (energy expenditure ~25% of daily caloric need).
| Study group | Role | What they receive |
|---|---|---|
| High Fat Overfeeding | Experimental | 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. Receives: Behavioral: High Fat Overfeeding |
| High Fat Overfeeding + Exercise | Experimental | 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 Receives: Behavioral: High Fat Overfeeding + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity via Oral Glucose Insulin Sensitivity Index
Oral Glucose Insulin Sensitivity
Measured: Immediately following high fat diet intervention
Secondary outcomes (2)
Metabolic Flexibility (Respiratory Exchange Ratio) via Indirect Calorimetry
Respiratory Exchange Ratio, Glucose Oxidation, Fatty Acid Oxidation
Measured: Immediately following high fat diet intervention
Carotid Femoral Pulse Wave velocity
Carotid Femoral Pulse Wave Velcoity
Measured: Immediately following high fat diet intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start10 Feb 2025
- Primary completion7 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Sensitivity/ResistanceStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Barberio, George Washington University
- Investigators
- Matthew Barberio, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633704
- Sponsor's protocol ID
- NCR246197
- Acronym
- HFDEXC
- Status last verified
- Apr 2026
- First submitted
- 11 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data will be annonymized by study ID number and removed of any identifying information. Data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Exercise on Acute High-fat Overfeeding
- ClinicalTrials.gov ID
- NCT07633704
- Acronym / sponsor ID
- HFDEXC / NCR246197
- Conditions
- Insulin Sensitivity/Resistance
- Keywords
- Metabolism, Exercise, Substrate Oxidation, Overfeeding, High Fat Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fat Overfeeding | Experimental | Behavioral: High Fat OverfeedingResting 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. |
| High Fat Overfeeding + Exercise | Experimental | Behavioral: High Fat Overfeeding + ExerciseOn 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Fat OverfeedingCaloric intake 180% of daily caloric need with 65% from fat | Behavioural | High Fat Overfeeding |
| High Fat Overfeeding + ExerciseCaloric intake 180% of daily caloric need with 65% from fat with acute moderate exercise (energy expenditure ~25% of daily caloric need). | Behavioural | High Fat Overfeeding + Exercise |
Primary outcome
Insulin Sensitivity via Oral Glucose Insulin Sensitivity Index
Time frame: Immediately following high fat diet intervention
Oral Glucose Insulin Sensitivity
2 secondary outcomes
Metabolic Flexibility (Respiratory Exchange Ratio) via Indirect Calorimetry
Time frame: Immediately following high fat diet intervention
Carotid Femoral Pulse Wave velocity
Time frame: Immediately following high fat diet intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual data will be annonymized by study ID number and removed of any identifying information. Data will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Barberio principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fat Overfeeding and High Fat Overfeeding + Exercise in people with Insulin Sensitivity/Resistance, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity via Oral Glucose Insulin Sensitivity Index (time frame: Immediately following high fat diet intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.