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Other
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%
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My BMI is either between 18.5-24.9 or 30.0-50.0.
Select...
My liver fat, blood sugar, and cholesterol levels are within normal ranges.
Select...
I am obese with high liver fat, blood sugar, or HbA1C levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and after 4 to 8-weeks of weight maintenance, after 7-10% weight loss (~6-7 months) and after independent weight loss (12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after 4 to 8-weeks of weight maintenance, after 7-10% weight loss (~6-7 months) and after independent weight loss (12 months)
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 cytokine concentrations
24-hour glucose concentrations
24-hour hormone concentrations
+51 moreTrial 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.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,627 Total Patients Enrolled
77 Trials studying Obesity
13,637 Patients Enrolled for Obesity
Pershing Square FoundationUNKNOWN
Samuel Klein, MDPrincipal InvestigatorWashington University School of Medicine
27 Previous Clinical Trials
2,041 Total Patients Enrolled
16 Trials studying Obesity
1,756 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have gone through menopause naturally or due to medical reasons.I can complete all tests without issues from severe mobility problems, missing limbs, or metal implants.I have had weight loss surgery that changed my digestive system.My cancer has been in remission for less than 5 years.I have a serious health condition like severe heart, lung, kidney disease, or diabetes needing medication.I am not on medications that could interfere with the study or increase risk during it.I am unable to understand and give voluntary consent for treatment.My liver fat, blood sugar, and cholesterol levels are within normal ranges.I drink more than 21 units of alcohol per week if male, or more than 14 if female.My BMI is either between 18.5-24.9 or 30.0-50.0.I have been diagnosed with polycystic ovary syndrome.You smoke more than 10 cigarettes per week.I have not taken antibiotics in the last 60 days.You follow a vegan or vegetarian diet, have lactose intolerance, or have severe allergies to eggs, fish, nuts, wheat, or soy.You exercise for at least 250 minutes per week, like brisk walking.Your weight has changed by more than 4% in the last 2 months before the study.I am obese with high liver fat, blood sugar, or HbA1C levels.You use marijuana more than twice a week, or use illegal drugs.You have a serious mental illness.I had lap band surgery in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Metabolically normal obese - Baseline testing only
- Group 2: Metabolically abnormal obese - Plant-based very-low-fat diet
- Group 3: Metabolically normal lean - Baseline testing only
- Group 4: Metabolically abnormal obese - Mediterranean diet
- Group 5: Metabolically abnormal obese - Low carbohydrate ketogenic diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for enrolling in this medical experiment?
"For this clinical trial, 160 participants aged 18 to 55 who have been diagnosed with obesity are being sought. The BMI of metabolically normal lean subjects must be between 18.5 and 24.9 kg/m2; obese individuals should have a BMI ranging from 30-50kg/m2. Furthermore, the intrahepatic triglyceride content (IHTG) needs to not exceed 5%, plasma triglycerides should stay below 150 mg/dl while glucose concentrations need to remain lower than 100mg/dl after fasting and 140mg/dl post an oral glucose tolerance test (OGTT). Moreover, hemoglobin A1C levels"
Answered by AI
What objectives is this trial seeking to accomplish?
"The primary aim of this exploratory study is to observe changes in insulin sensitivity over time. Other objectives include examining incorporation rates of heavy water into proteins, 24-hour hormone concentrations and the gut microbiome through bacterial RNA sequencing and metabolite analysis."
Answered by AI
Is the demographic for this research restricted to participants under 35 years of age?
"This trial only accepts participants of legal age and under the maximum cap of 55 years old."
Answered by AI
Are there vacancies for participants in this research endeavor?
"Data hosted on clinicaltrials.gov displays that this trial is still in search of participants, with the original posting having occurred on February 1st 2016 and being revised most recently on December 6th 2022."
Answered by AI
What is the scope of participants involved in this clinical research?
"Correct. According to the clinicaltrials.gov repository, this medical study is actively searching for volunteers. Posting occured on February 1st 2016 and was most recently modified on December 6th 2022 with 160 participants desired from one location."
Answered by AI
Who else is applying?
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Recent research and studies
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