DGA Diet Patterns for Obesity

(DGA4ME Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Kevin D Laugero, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: USDA, Western Human Nutrition Research Center

Must not be taking: Antipsychotics, Antibiotics, Corticosteroids

Disqualifiers: COVID-19, Tobacco, Vegan, Alcohol, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial will test different diets to see which one best helps people manage their weight and improve heart and metabolic health. Participants will follow various diets, and researchers will compare the results.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications for elevated lipids, elevated glucose, high blood pressure, weight loss, or conditions that require corticosteroids to participate in this study.

What data supports the effectiveness of the DGA Mediterranean diet pattern treatment for obesity?

Research suggests that following a Mediterranean diet, which is part of the Dietary Guidelines for Americans, may help with obesity. This diet is linked to healthier eating habits and could potentially aid in weight management. ^{1 2 3 4 5}

Is the DGA Mediterranean diet pattern safe for humans?

The DGA Mediterranean diet pattern is generally considered safe for humans as it is part of the Dietary Guidelines for Americans, which aim to promote health and prevent chronic diseases. ^{1 2 3 4 5}

How does the DGA Mediterranean diet pattern treatment for obesity differ from other treatments?

The DGA Mediterranean diet pattern is unique because it emphasizes whole foods like fruits, vegetables, whole grains, and healthy fats, which align with the Dietary Guidelines for Americans. This approach contrasts with typical Western diets that are often high in processed foods and unhealthy fats, making it a novel strategy for addressing obesity. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with obesity, defined as a BMI of 27-39.9 or body fat percentage of 32-50%. Participants should have certain cardiometabolic risk factors like elevated fasting glucose, triglycerides, blood pressure, or A1C levels. They must be willing to have blood drawn and not currently use dietary supplements, alcohol excessively, or caffeine on lab days. Those with recent serious medical conditions or surgeries that affect diet are excluded.

Inclusion Criteria

At least one of the following: Fasting glucose ≥100 mg/dL but <126 mg/dL or Fasting triglyceride ≥125 mg/dL or HDL-cholesterol ≤50 mg/dL or Blood Pressure (BP): Systolic BP ≥130 mmHg or Diastolic BP ≥85 mmHg or Hemoglobin A1C ≥ 5.7 and <6.5%

Body Mass Index (BMI) 23-39.9 kg/m2 or 32-50% body fat percentage

Willingness to have blood drawn

Exclusion Criteria

Unwillingness to consume intervention foods and beverages

Unwillingness to cease alcohol intake as required for specific duration of the study

Excessive intake of caffeine containing products (excessive defined as ≥ 400 mg/day)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Controlled Feeding

Participants are assigned to one of three diet patterns for an 8-week controlled feeding period

8 weeks

Weekly visits for monitoring and diet adjustments

Post-Diet Testing

Post-diet testing to assess changes in various health parameters

2 weeks

1 visit (in-person)

Follow-up

Participants receive dietary education and are observed for long-term effects

18 weeks

Periodic visits for assessment and education

Treatment Details

Interventions

• DGA Mediterranean diet pattern (Behavioural Intervention)
• TAD diet pattern (Behavioural Intervention)

Trial Overview The study compares the effects of following a Mediterranean-style diet from the Dietary Guidelines for Americans (DGA) with energy restrictions aimed at weight loss versus maintaining current weight. It will assess which approach better improves cardiometabolic risk factors compared to a typical American diet (TAD).

Participant Groups

Group I: TAD diet pattern Experimental Treatment 1 Intervention

Typical American Diet (TAD) with negative energy balance (\~25% calorie reduction compared to needs) which mimics intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium based on data from What We Eat in America (WWEIA).

Group II: DGA Mediterranean diet pattern, negative energy balance Experimental Treatment 1 Intervention

Negative energy balance (\~25% calorie reduction compared to needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.

Group III: DGA Mediterranean diet pattern, energy balance Experimental Treatment 1 Intervention

Diet plan focused on energy balance (meets calorie needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.

DGA Mediterranean diet pattern is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Dietary Guidelines for Americans for:

• General health promotion
• Cardiometabolic risk reduction
• Weight management

🇪🇺 Approved in European Union as Mediterranean diet pattern for:

• Cardiovascular health
• Type 2 diabetes prevention
• Obesity management

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC Davis, Western Human Nutrition Research Center Davis, CA

Who Is Running the Clinical Trial?

USDA, Western Human Nutrition Research Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Substitution Modeling Shows Simple Dietary Changes Increase Mediterranean-Style Diet Pattern Scores for US Adults. [2022] A Mediterranean-style diet pattern (MSDP) is a recommended diet pattern in the 2020-2025 Dietary Guidelines for Americans. Few studies report widespread adherence to the diet, which suggests Americans may benefit from strategies to help them improve alignment to an MSDP.

2. United States pubmed.ncbi.nlm.nih.gov

Assessing the Public's Comprehension of Dietary Guidelines: Use of MyPyramid or MyPlate Is Associated with Healthier Diets among US Adults. [2020] The Dietary Guidelines for Americans (DGA) provide a framework for food and nutrition programming in the United States as well as the foundation for individualized dietary guidance. Public utilization of the DGA, specifically the MyPyramid or MyPlate tool, is not well studied.

3. United States pubmed.ncbi.nlm.nih.gov

Diet Indices Reflecting Changes to Dietary Guidelines for Americans from 1990 to 2015 Are More Strongly Associated with Risk of Coronary Artery Disease Than the 1990 Diet Index. [2022] The Dietary Guidelines for Americans (DGAs) provide dietary recommendations for the general population with the intent of preventing chronic disease such as cardiovascular disease. An evaluation of whether updated versions of the DGAs accomplish this goal is lacking.

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Dietary Guidelines for Americans (2020-2025): Pulses, Dietary Fiber, and Chronic Disease Risk-A Call for Clarity and Action. [2021] The 2020-2025 Dietary Guidelines for Americans (DGA) were recently released [...].

5. England pubmed.ncbi.nlm.nih.gov

Adherence to a priori dietary patterns in relation to obesity: results from two cycles of the Canadian National Nutrition Survey. [2023] To test whether adherence to the Mediterranean diet, the Dietary Approaches to Stop Hypertension (DASH) or a dietary pattern in-line with the 2015-2020 Dietary Guidelines for Americans (DGA) was associated with obesity.