300 Participants Needed

Specific Diets for Obesity

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Overseen ByBrittney Mason
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 | Division of ...

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

If you are very overweight and have certain measures of body fat and blood sugar levels, you won't be able to participate.
I am obese but metabolically healthy with specific health markers within normal ranges.
I am lean, with healthy levels of body fat, blood sugar, and cholesterol.

Exclusion Criteria

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.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Comprehensive baseline assessments including insulin sensitivity, β-cell function, and various metabolic parameters

1-2 weeks
1 visit (in-person)

Dietary Intervention

Participants are randomized to follow a Mediterranean, low-carbohydrate ketogenic, or low-fat diet to assess cardiometabolic health

4-8 weeks
Weekly visits (in-person or virtual)

Longitudinal Assessment

Annual assessments of cardiometabolic health including insulin sensitivity, exosome signaling, and adipose tissue volumes

5 years
Annual visits (in-person)

Follow-up

Participants are monitored for long-term changes in cardiometabolic health post-intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Low-carbohydrate, ketogenic diet
  • Low-fat diet
  • Mediterranean diet
Trial Overview 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.
How Is the Trial Designed?
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.

Low-carbohydrate, ketogenic diet is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Ketogenic diet for:
  • Epilepsy
  • Type 2 diabetes management
  • Weight loss
🇪🇺
Approved in European Union as Ketogenic diet for:
  • Epilepsy
  • Type 2 diabetes management
🇨🇦
Approved in Canada as Ketogenic diet for:
  • Epilepsy
  • Type 2 diabetes management

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Centene Corporation

Collaborator

Trials
1
Recruited
300+

Published Research Related to This Trial

The very-low-calorie ketogenic diet (VLCKD) is an effective lifestyle intervention for managing overweight and obesity, leading to significant weight loss and improvements in conditions like hypertension, type 2 diabetes, and dyslipidemia.
This review synthesizes evidence from four key studies, highlighting VLCKD's potential benefits and offering practical recommendations for its implementation in adults.
Very-low-calorie ketogenic diet for the management of obesity, overweight and related disorders.Castellana, M., Biacchi, E., Procino, F., et al.[2021]
Current guidelines recommend a comprehensive treatment for obesity that includes diet, exercise, and behavior therapy, emphasizing the importance of cognitive change for better long-term results.
Cognitive behavioral therapy combined with the Mediterranean diet has shown effectiveness in promoting weight loss and improving health markers, making it a practical approach for managing obesity.
Nutritional and behavioral modification therapies of obesity: facts and fiction.Vranešić Bender, D., Krznarić, Z.[2018]
In a study of 200 obese adults over six months, the low-carbohydrate ketogenic diet (LCKD) resulted in a significant weight loss of 13.0 kg compared to 4.7 kg with the low-caloric fat low diet (LCLF), indicating that LCKD is more effective for weight reduction.
The LCKD also led to greater reductions in fat mass and visceral fat, while not increasing cholesterol or uric acid levels, suggesting it is a safe and effective option for obesity management.
The effect of low-carbohydrate ketogenic diet in the management of obesity compared with low caloric, low-fat diet.Al Aamri, KS., Alrawahi, AH., Al Busaidi, N., et al.[2022]

Citations

Very-low-calorie ketogenic diet for the management of obesity, overweight and related disorders. [2021]
Nutritional and behavioral modification therapies of obesity: facts and fiction. [2018]
The effect of low-carbohydrate ketogenic diet in the management of obesity compared with low caloric, low-fat diet. [2022]
Italian Ketogenic Mediterranean Diet in Overweight and Obese Patients with Prediabetes or Type 2 Diabetes. [2022]
[Low-carbohydrate diets for obesity]. [2008]
Ketogenic diets for weight loss: A review of their principles, safety and efficacy. [2022]
Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study. [2022]
Low-carbohydrate ketogenic diets in body weight control: A recurrent plaguing issue of fad diets? [2021]
Pre ketogenic diet counselling. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Dietary Intervention for Overweight and Obese Adults: Comparison of Low-Carbohydrate and Low-Fat Diets. A Meta-Analysis. [2022]
11.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Efficacy of low-carbohydrate diet in the treatment of obesity in adolescents]. [2007]
Short- and long-term effects of very low- and low-calorie ketogenic diets on metabolism and cardiometabolic risk factors: a narrative review. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Clinical trial experience with fat-restricted vs. carbohydrate-restricted weight-loss diets. [2007]
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