DGA Diet Patterns for Obesity

(DGA4ME Trial)

Overseen By Beverly Miller, BS, RDN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: USDA, Western Human Nutrition Research Center

Must not be taking: Antipsychotics, Antibiotics, Corticosteroids

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

123 Participants Needed

What You Need to Know Before You Apply

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.

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}

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}

Who Is on the Research Team?

Kevin D Laugero, PhD

Principal Investigator

USDA, Western Human Nutrition Research Center

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• DGA Mediterranean diet pattern
• TAD diet pattern

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).

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

USDA, Western Human Nutrition Research Center

Lead Sponsor

Trials

64

Recruited

19,100+

Published Research Related to This Trial

A study of 19,978 US adults found that simple isocaloric food substitutions, like increasing olive oil use and swapping refined grains for whole grains, can significantly improve adherence to a Mediterranean-style diet pattern (MSDP).

Adding honey to these dietary substitutions not only enhances the taste but also helps maintain improved adherence to the MSDP without compromising nutritional value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substitution Modeling Shows Simple Dietary Changes Increase Mediterranean-Style Diet Pattern Scores for US Adults. Overcash, F., Crusan, AC.[2022]

In a study of 3,194 US adults, those who used the MyPyramid or MyPlate dietary plans had healthier diets, showing lower dietary energy density and reduced intake of refined grains, added sugars, and solid fats.

Users of these dietary tools also consumed more whole grains and dark green vegetables, indicating that knowledge and application of the Dietary Guidelines for Americans can positively influence dietary choices.

NCBI (Pubmed)

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. Schwartz, JL., Vernarelli, JA.[2020]

Updates to the Dietary Guidelines for Americans (DGAs) have led to more recent diet quality indices that show a stronger association with the risk of coronary artery disease, based on a study of 3267 participants from the Framingham Heart Study.

While adherence to any dietary index was linked to a lower risk of cardiovascular diseases overall, the improvements in diet indices did not show a significant impact on the risk of stroke or heart failure.

NCBI (Pubmed)

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. Rebholz, CM., Kim, H., Ma, J., et al.[2022]

The 2020-2025 Dietary Guidelines for Americans provide updated recommendations aimed at improving nutritional health and reducing the risk of chronic diseases among the population.

These guidelines emphasize the importance of a balanced diet, including a variety of fruits, vegetables, whole grains, and lean proteins, while also addressing the need to limit added sugars, saturated fats, and sodium.

NCBI (Pubmed)

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. Thompson, HJ.[2021]

Adherence to the DASH diet and the 2015-2020 Dietary Guidelines for Americans is linked to a lower likelihood of obesity among Canadian adults, based on analysis of dietary recall data from over 23,000 participants across two survey cycles.

While the Mediterranean diet showed a similar trend, its association with obesity was not statistically significant in the more recent data, suggesting that DASH and DGA may be more effective dietary patterns for weight management.

NCBI (Pubmed)

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. Ng, AP., Jessri, M., L'Abbé, MR.[2023]

Citations

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

Substitution Modeling Shows Simple Dietary Changes Increase Mediterranean-Style Diet Pattern Scores for US Adults. [2022]

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]

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]

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]

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]