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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%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed annually for 5 years
Awards & highlights

Study 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.

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
1,931 Previous Clinical Trials
2,299,593 Total Patients Enrolled
77 Trials studying Obesity
13,517 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be involved in this investigation?

"Eligible participants should have obesity and fall between the ages of 18-55 to be considered for this trial. Approximately 300 participants are being enrolled in total."

Answered by AI

Does the cutoff age of this trial extend beyond 80 years?

"This experiment is recruiting adults aged 18-55 to participate."

Answered by AI

How many subjects are engaged in this research endeavor?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial is actively searching for volunteers to participate in their study. The research was initially posted on October 8th 2019 and has been updated as recently as November 30th 2021. Three hundred individuals are desired from a single location."

Answered by AI

Is the enrollment phase of this experiment ongoing?

"According to the data available on clinicaltrials.gov, this experiment is actively searching for participants - it was initially listed on October 8th 2019 and last updated November 30th 2021."

Answered by AI

What are the overarching objectives of this clinical trial?

"This clinical trial's main goal is to measure the change in insulin sensitivity among Metabolically Healthy Lean, Metabolically Healthy Obese and Metabolically Unhealthy Obese subjects. Secondary objectives comprise of recording changes in 24-hour hormone concentrations, leg adipose tissue volumes and gut microbiome (through bacterial RNA sequencing and metabolite analysis)."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Missouri
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I've been trying for 20+ years to lose weight...fad diets, exercise, lifestyle changes, doctors, weight loss programs, pills, etc. Some methods worked better than others but I have never come close to achieving my goal weight. While I have been able to lose over 100lbs over a 4 year period, I am still struggling, and am, in fact, gaining again. The excess weight is affecting my daily life like it never has before and I need help.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

when can I get started?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Washington University School of Medicine: < 48 hours
Average response time
  • < 2 Days
~164 spots leftby Oct 2029