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Specific 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 healthy obese subjects must have a BMI 30-49.9 kg/m2; IHTG content ≤5%, serum TG concentration <150 mg/dl, fasting plasma glucose concentration <100 mg/dl, 2-hr OGTT plasma glucose concentration ≤140 mg/dl, and HbA1C ≤5.6%.
Metabolically healthy lean subjects must have a body mass index (BMI) 18.5-24.9 kg/m2, intrahepatic triglyceride (IHTG) content ≤5%, serum triglyceride (TG) concentration <150 mg/dl, fasting plasma glucose concentration <100 mg/dl, 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≤140 mg/dl, and hemoglobin A1C (HbA1C) ≤5.6%.
Must not have
Conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
Cancer or cancer that has been in remission for <5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed annually for 5 years
Awards & highlights

Summary

This trial is testing different diets to see which is best for people with obesity who are at risk for heart and metabolic problems. It will also study why some people with obesity don't have these problems while others do.

Who is the study for?
This trial is for adults with obesity, either metabolically healthy or unhealthy, who have specific body mass index (BMI) and blood sugar levels. It excludes those with certain medical conditions like severe organ dysfunction, cancer within the last 5 years, major psychiatric illness, recent bariatric surgery, unstable weight or diet restrictions due to allergies.Check my eligibility
What is being tested?
The study tests how different diets—Mediterranean, low-fat, and ketogenic—affect heart health and metabolism in obese individuals over five years. Participants will be monitored annually to see which diet works best for improving or maintaining metabolic health.See study design
What are the potential side effects?
While not explicitly stated for this nutritional study, potential side effects may include changes in digestion or energy levels as the body adapts to new diets. Some might experience nutrient deficiencies if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am obese but metabolically healthy with specific health markers within normal ranges.
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I am lean, with healthy levels of body fat, blood sugar, and cholesterol.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can complete all tests; no severe mobility issues, missing limbs, or metal implants that affect imaging.
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My cancer has been in remission for less than 5 years.
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I am unable to understand and give informed consent.
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I have had weight loss surgery that changed my digestive system.
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I do not drink more than 2 (women) or 3 (men) alcoholic beverages a day.
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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 have gone through menopause naturally or due to a medical procedure.
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I have severe anemia.
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I have a serious health condition like severe heart, lung, kidney disease, or diabetes needing medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~performed annually for 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and performed annually for 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in insulin sensitivity
Insulin sensitivity
Secondary outcome measures
24-hour glucose concentrations
24-hour hormone concentrations
Abdominal adipose tissue volumes
+27 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Metabolically unhealthy obese - Mediterranean dietExperimental Treatment2 Interventions
Metabolically abnormal obese - Persons with obesity with glucose levels higher than recommended and a moderate to high amount of fat in the liver randomized to the Mediterranean diet group.
Group II: Metabolically unhealthy obese - Low-fat dietExperimental Treatment2 Interventions
Metabolically abnormal obese - Persons with obesity with glucose levels higher than recommended and a moderate to high amount of fat in the liver randomized to the low-fat diet group.
Group III: Metabolically unhealthy obese - Low-carbohydrate ketogenic dietExperimental Treatment2 Interventions
Metabolically abnormal obese - Persons with obesity with glucose levels higher than recommended and a moderate to high amount of fat in the liver randomized to the low-carbohydrate, ketogenic diet group.
Group IV: Metabolically normal obese - Low-fat dietExperimental Treatment2 Interventions
Metabolically normal obese - Persons with obesity that have good glucose (sugar) control, normal plasma triglyceride (fat) levels and a low liver fat content randomized to the low-fat diet group.
Group V: Metabolically healthy obese - Mediterranean dietExperimental Treatment2 Interventions
Metabolically normal obese - Persons with obesity that have good glucose (sugar) control, normal plasma triglyceride (fat) levels and a low liver fat content randomized to the Mediterranean diet group.
Group VI: Metabolically healthy obese - Low-carbohydrate ketogenic dietExperimental Treatment2 Interventions
Metabolically normal obese - Persons with obesity that have good glucose (sugar) control, normal plasma triglyceride (fat) levels and a low liver fat content randomized to the low-carbohydrate ketogenic diet group.
Group VII: Metabolically healthy leanExperimental Treatment1 Intervention
Metabolically normal lean - Lean individuals that have good glucose (sugar) control, normal plasma triglyceride (fat) levels and a low liver fat content.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mediterranean diet
2016
Completed Phase 4
~3200
Low-fat diet
2007
N/A
~440

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,258 Total Patients Enrolled
79 Trials studying Obesity
13,826 Patients Enrolled for Obesity
Centene CorporationUNKNOWN
Samuel Klein, MDPrincipal InvestigatorWashington University School of Medicine
27 Previous Clinical Trials
1,921 Total Patients Enrolled
16 Trials studying Obesity
1,636 Patients Enrolled for Obesity

Media Library

Low-carbohydrate, ketogenic diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04131166 — N/A
Obesity Research Study Groups: Metabolically healthy obese - Mediterranean diet, Metabolically unhealthy obese - Mediterranean diet, Metabolically unhealthy obese - Low-carbohydrate ketogenic diet, Metabolically normal obese - Low-fat diet, Metabolically healthy lean, Metabolically healthy obese - Low-carbohydrate ketogenic diet, Metabolically unhealthy obese - Low-fat diet
Obesity Clinical Trial 2023: Low-carbohydrate, ketogenic diet Highlights & Side Effects. Trial Name: NCT04131166 — N/A
Low-carbohydrate, ketogenic diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04131166 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT04131166 — N/A
~156 spots leftby Oct 2029
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