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Diets for Obesity

N/A

Recruiting

Led By Samuel Klein, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Metabolically normal lean subjects must have a BMI ≥18.5 and ≤24.9 kg/m2; Obese subjects must have a BMI ≥30.0 and ≤50.0 kg/m2

Metabolically normal lean and obese subjects must have intrahepatic triglyceride (IHTG) content ≤5%; plasma triglyceride (TG) concentration <150 mg/dl; fasting plasma glucose concentration <100 mg/dl, 2-hr oral glucose tolerance plasma glucose concentration <140 mg/dl, and hemoglobin A1C ≤5.6%

Must not have

Medical, surgical, or biological menopause

Previous bariatric surgery where the gastrointestinal tract is reconstructed such as Roux-en-Y, sleeve gastrectomy and biliopancreatic diversion surgeries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and during 4 to 8-weeks of weight maintenance, 7-10% weight loss (~6-7 months) and independent weight loss (12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether different weight-loss diets can help people with obesity avoid developing obesity-related conditions like type 2 diabetes and heart disease.

Who is the study for?

This trial is for obese individuals with specific metabolic abnormalities, such as high intrahepatic triglyceride levels or abnormal glucose readings. Participants should have a BMI between 30.0 and 50.0 kg/m2 and not be heavy smokers, drug users, or have conditions that interfere with the study. Pregnant women, those on certain medications, or with severe diseases are excluded.

What is being tested?

The study aims to understand why some obese individuals develop diabetes and heart disease while others don't. It compares three diets: Mediterranean, low-carbohydrate ketogenic, and very-low-fat plant-based in metabolically abnormal obese participants to see which diet might be most effective for weight loss and health improvement.

What are the potential side effects?

Potential side effects from these diets may include nutrient deficiencies if not properly managed, digestive changes like constipation or diarrhea depending on the fiber content of the diet chosen, fatigue during initial adjustment periods especially in ketogenic diets due to lower carb intake.

Eligibility Criteria

Inclusion Criteria

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

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My BMI is either between 18.5-24.9 or 30.0-50.0.

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My liver fat, blood sugar, and cholesterol levels are within normal ranges.

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I am obese with high liver fat, blood sugar, or HbA1C levels.

Exclusion Criteria

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

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I have gone through menopause naturally or due to medical reasons.

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I have had weight loss surgery that changed my digestive system.

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My cancer has been in remission for less than 5 years.

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I have a serious health condition like severe heart, lung, kidney disease, or diabetes needing medication.

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I can complete all tests without issues from severe mobility problems, missing limbs, or metal implants.

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I am not on medications that could interfere with the study or increase risk during it.

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I drink more than 21 units of alcohol per week if male, or more than 14 if female.

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I am unable to understand and give voluntary consent for treatment.

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I had lap band surgery in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after 4 to 8-weeks of weight maintenance and after 7-10% weight loss (~6-7 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after 4 to 8-weeks of weight maintenance and after 7-10% weight loss (~6-7 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 4 to 8-weeks of weight maintenance and after 7-10% weight loss (~6-7 months) 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 in insulin sensitivity

Insulin sensitivity

Secondary study objectives

24-hour cytokine concentrations

24-hour glucose concentrations

24-hour hormone concentrations

+51 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Metabolically abnormal obese - Plant-based very-low-fat dietExperimental Treatment1 Intervention

Metabolically abnormal obese - Persons with obesity with glucose levels higher than recommended and a moderate to high amount of fat in the liver. Dietary intervention - A plant-based diet high in complex carbohydrates and low in fat, protein, and sodium, with approximately 70% of daily calories from carbohydrates, 15% from fat, and 15% from protein.

Group II: Metabolically abnormal obese - Mediterranean dietExperimental Treatment1 Intervention

Metabolically abnormal obese - Persons with obesity with glucose levels higher than recommended and a moderate to high amount of fat in the liver. Dietary intervention - A nutritionally balanced diet that includes fruits, vegetables, fish, beans, whole grains, and olive oil with approximately 50% of daily calories coming from complex carbohydrates, 30% of calories from fat, and 20% of calories from protein.

Group III: Metabolically abnormal obese - Low carbohydrate ketogenic dietExperimental Treatment1 Intervention

Metabolically abnormal obese - Persons with obesity with glucose levels higher than recommended and a moderate to high amount of fat in the liver. Dietary intervention - A very-low-carbohydrate, adequate protein, high-fat diet containing 20 grams of carbohydrate or less per day (about 5% of calories), derived mainly from vegetables.

Group IV: Metabolically normal obese - Baseline testing onlyActive Control1 Intervention

Metabolically normal obese - Persons with obesity that have good glucose (sugar) control, normal plasma triglyceride (fat) levels and a low liver fat content. Dietary intervention - None.

Group V: Metabolically normal lean - Baseline testing onlyActive Control1 Intervention

Metabolically normal lean - Lean individuals that have good glucose (sugar) control, normal plasma triglyceride (fat) levels and a low liver fat content. Dietary intervention - None.

0 / 12Eligibility criteria met