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Specific Diets for Obesity
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- If you are very overweight and have certain measures of body fat and blood sugar levels, you won't be able to participate.You have a serious mental illness.I can complete all tests; no severe mobility issues, missing limbs, or metal implants that affect imaging.My cancer has been in remission for less than 5 years.I am unable to understand and give informed consent.You don't eat animal products or have severe allergies to eggs, fish, nuts, wheat, soy, or other foods that can cause a serious allergic reaction.I have had weight loss surgery that changed my digestive system.I do not drink more than 2 (women) or 3 (men) alcoholic beverages a day.I am obese but metabolically healthy with specific health markers within normal ranges.I am not on medications that could interfere with the study or increase risk during it.I have gone through menopause naturally or due to a medical procedure.I have been diagnosed with polycystic ovary syndrome.I have severe anemia.You use tobacco products regularly.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 joining the study.I have a serious health condition like severe heart, lung, kidney disease, or diabetes needing medication.I had lap band surgery in the last 3 years.I have not taken antibiotics in the last 60 days.I am lean, with healthy levels of body fat, blood sugar, and cholesterol.
- Group 1: Metabolically healthy obese - Mediterranean diet
- Group 2: Metabolically unhealthy obese - Mediterranean diet
- Group 3: Metabolically unhealthy obese - Low-carbohydrate ketogenic diet
- Group 4: Metabolically normal obese - Low-fat diet
- Group 5: Metabolically healthy lean
- Group 6: Metabolically healthy obese - Low-carbohydrate ketogenic diet
- Group 7: Metabolically unhealthy obese - Low-fat diet
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
Does the cutoff age of this trial extend beyond 80 years?
"This experiment is recruiting adults aged 18-55 to participate."
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."
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."
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)."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Washington University School of Medicine: < 48 hours
Average response time
- < 2 Days
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