Protective Effect of Exercise on Acute High-fat Overfeeding (HFDEXC)
4 juni 2026 uppdaterad av: Matthew Barberio, George Washington University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
District of Columbia
-
Washington D.C., District of Columbia, Förenta staterna, 20052
- Milken Institute School of Public Health
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Caloric intake 180% of daily caloric need with 65% from fat
|
|
Experimentell: 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
|
Caloric intake 180% of daily caloric need with 65% from fat with acute moderate exercise (energy expenditure ~25% of daily caloric need).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Insulin Sensitivity via Oral Glucose Insulin Sensitivity Index
Tidsram: Immediately following high fat diet intervention
|
Oral Glucose Insulin Sensitivity
|
Immediately following high fat diet intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Metabolic Flexibility (Respiratory Exchange Ratio) via Indirect Calorimetry
Tidsram: Immediately following high fat diet intervention
|
Respiratory Exchange Ratio, Glucose Oxidation, Fatty Acid Oxidation
|
Immediately following high fat diet intervention
|
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Carotid Femoral Pulse Wave velocity
Tidsram: Immediately following high fat diet intervention
|
Carotid Femoral Pulse Wave Velcoity
|
Immediately following high fat diet intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Matthew Barberio, George Washington University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 februari 2025
Primärt slutförande (Faktisk)
7 april 2026
Avslutad studie (Faktisk)
9 april 2026
Studieregistreringsdatum
Först inskickad
11 maj 2026
Först inskickad som uppfyllde QC-kriterierna
4 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 juni 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCR246197
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Individual data will be annonymized by study ID number and removed of any identifying information.
Data will be shared upon reasonable request.
Tidsram för IPD-delning
Upon publication, data will be shared upon reasonable request to the corresponding author.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .