Specific Diets for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
The purposes of this study are: 1) to determine the mechanisms responsible for the development of cardiometabolic complications in some, but not all people with obesity; 2) determine the best dietary approach for cardiometabolic health; and 3) understand why some people have a stable metabolic phenotype over time whereas cardiometabolic health improves or worsens in others.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that could affect the study's results, like steroids or certain cholesterol-lowering drugs, if they can't be temporarily stopped. If you're on such medications, you might need to pause them for the study.
Is the ketogenic diet safe for humans?
Research suggests that ketogenic diets, which are low in carbohydrates and high in fats, are generally safe for weight loss and can improve certain health markers like triglyceride levels. However, long-term use may pose risks, such as kidney issues, especially in people with obesity, due to high fat and protein intake.12345
How does the specific diet treatment for obesity differ from other treatments?
The specific diet treatment for obesity, which includes low-carbohydrate ketogenic, low-fat, and Mediterranean diets, is unique because it offers multiple dietary approaches that can be tailored to individual preferences and metabolic responses. The ketogenic diet, in particular, is noted for its low carbohydrate content, which can lead to greater short-term weight loss compared to low-fat diets, although its long-term safety and efficacy are still under study.678910
What data supports the effectiveness of specific diets for obesity treatment?
Research shows that very-low-calorie ketogenic diets can lead to significant weight loss and improvements in conditions like high blood pressure and type 2 diabetes. Additionally, the Mediterranean diet is linked to weight loss and better health markers, such as blood pressure and cholesterol levels.46111213
Who Is on the Research Team?
Samuel Klein, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Comprehensive baseline assessments including insulin sensitivity, β-cell function, and various metabolic parameters
Dietary Intervention
Participants are randomized to follow a Mediterranean, low-carbohydrate ketogenic, or low-fat diet to assess cardiometabolic health
Longitudinal Assessment
Annual assessments of cardiometabolic health including insulin sensitivity, exosome signaling, and adipose tissue volumes
Follow-up
Participants are monitored for long-term changes in cardiometabolic health post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- Low-carbohydrate, ketogenic diet
- Low-fat diet
- Mediterranean diet
Low-carbohydrate, ketogenic diet is already approved in United States, European Union, Canada for the following indications:
- Epilepsy
- Type 2 diabetes management
- Weight loss
- Epilepsy
- Type 2 diabetes management
- Epilepsy
- Type 2 diabetes management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Centene Corporation
Collaborator