Status:

TERMINATED

Metabolic Adaptations to High-fat Diet

Lead Sponsor:

George Washington University

Conditions:

Adiposity

Insulin Sensitivity

Eligibility:

All Genders

20-45 years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 12 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT06537401

Start Date

August 12 2024

End Date

December 31 2024

Last Update

August 26 2025

Active Locations (1)

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1

George Washington University School of Public Health

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