Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05165706
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Dietary Intervention Mediterranean Low Carbohydrate Diet — BEHAVIORAL
    Assigned participants will receive instruction by a registered dietitian on a diet that is high in unsaturated fats and low in carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.
  • Dietary Intervention Standard Low Carbohydrate Diet — BEHAVIORAL
    Assigned participants will receive instruction by a registered dietitian on a low carbohydrate diet that is high in fats found in the typical American diet. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.
  • Dietary Intervention Standard Low Fat Diet — BEHAVIORAL
    Assigned participants will receive instruction by a registered dietitian on a low fat diet that is high in complex carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.

Study Details

This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR). Blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. Additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.

Key Dates

Start date
Jan 31, 2019
Status verified
Dec 2024
Primary completion
Nov 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Mediterranean Low Carbohydrate Diet
    Assigned participants will receive instruction by a registered dietitian on a diet that is high in unsaturated fats and low in carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.
  • Experimental: Standard Low Carbohydrate Diet
    Assigned participants will receive instruction by a registered dietitian on a low carbohydrate diet that is high in fats found in the typical American diet. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.
  • Experimental: Low Fat, Healthy Carbohydrate Diet
    Assigned participants will receive instruction by a registered dietitian on a low fat diet that is high in complex carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.

Primary Outcome Measure

Change from baseline on the 2-stage Steady State Plasma Glucose test [ Time Frame: Peak weight (4 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Ekrem M Ayhan, BS
[email protected]
908-619-5381
Dalia Perelman, MS, RD
[email protected]
Tracey L McLaughlin, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Type 2 diabetesObesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Stanford University· Stanford, CA

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