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Dietary Interventions for Insulin Resistance

N/A

Recruiting

Led By Tracey McLaughlin, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 35-65

Nondiabetic

Must not have

Patients with major organ disease

Patients with history of liposuction or bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-weight loss (8 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how loss of excess weight can help reduce risk of developing insulin resistance. Blood, fat and stool are monitored to measure cellular changes.

Who is the study for?

This trial is for adults aged 35-65 with a BMI of 25-35 who have maintained a stable weight and are not diabetic. It's not suitable for those with eating disorders, psychiatric conditions, high blood pressure, diabetes, history of certain weight loss surgeries, heavy alcohol use, recent significant weight change or major organ disease.

What is being tested?

The study tests how different diets (Mediterranean Low Carbohydrate Diet vs Standard Low Carbohydrate Diet vs Standard Low Fat Diet) affect the body's response to insulin over a period of 12 weeks. Participants will undergo diet interventions and regular monitoring including blood tests and radiological assessments.

What are the potential side effects?

While this trial focuses on dietary interventions which typically don't have severe side effects like drugs do, participants may experience changes in digestion or energy levels due to new diets. Individual responses to diet changes vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 65 years old.

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I do not have diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious condition affecting a major organ.

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I have had liposuction or bariatric surgery in the past.

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I have diabetes.

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I am currently taking medication for weight loss, statins, or oral steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-weight loss (8 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-weight loss (8 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-weight loss (8 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay

Change from baseline on the 2-stage Steady State Plasma Glucose test

Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard Low Carbohydrate DietExperimental Treatment1 Intervention

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.

Group II: Mediterranean Low Carbohydrate DietExperimental Treatment1 Intervention

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.

Group III: Low Fat, Healthy Carbohydrate DietExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met