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

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diet patterns affect weight loss and heart health. Researchers compare a Mediterranean-style diet, which follows the Dietary Guidelines for Americans and emphasizes fruits, vegetables, and whole grains, to a typical American diet (TAD diet pattern). They aim to determine if losing weight with this healthier diet improves heart health more than simply maintaining weight. Suitable participants have a Body Mass Index (BMI) between 23-39.9 or a body fat percentage between 32-50%, along with indicators like slightly high blood sugar or blood pressure. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of diet on health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the DGA Mediterranean diet offers significant health benefits. Studies have consistently found that people who follow this diet have a lower risk of heart problems. It is considered a healthy way of eating that can also aid in weight loss, especially with reduced calorie intake.

In contrast, the Typical American Diet (TAD) often includes many processed foods and sugars, linking it to higher risks of health issues like obesity and heart disease. However, this study modifies the TAD to include fewer calories, which might help reduce some of these risks.

Both diets in this trial involve consuming fewer calories, which can aid in weight loss and improve health. The study does not introduce new drugs or treatments, focusing solely on different eating habits. Therefore, safety concerns mainly involve adhering to healthy eating guidelines and ensuring safe food preparation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these diet patterns for obesity because they offer fresh perspectives on managing weight through tailored dietary approaches. The DGA Mediterranean diet pattern focuses on energy balance or a negative energy balance by emphasizing fruits, vegetables, and whole grains while limiting added sugars, saturated fats, and sodium. This contrasts with the Typical American Diet (TAD) pattern, which reduces calorie intake by about 25% while mimicking common American dietary habits. Unlike many standard weight-loss treatments that might focus on medication or surgery, these diet patterns promote sustainable lifestyle changes aligned with the Dietary Guidelines for Americans. The trial aims to uncover how these distinct dietary strategies can effectively combat obesity, offering potentially healthier and more accessible alternatives.

What evidence suggests that this trial's diet patterns could be effective for obesity?

Research has shown that following a Mediterranean diet, as recommended by the Dietary Guidelines for Americans (DGA), can help reduce the risk of obesity. This trial will test two variations of the DGA Mediterranean diet pattern: one focusing on energy balance and another on negative energy balance. The diet emphasizes fruits, vegetables, and whole grains while reducing added sugars and unhealthy fats. Studies have found that it may improve heart and metabolic health.

In contrast, the trial will also study the typical American diet (TAD) pattern, which is high in calories, fats, and salt, and is linked to weight gain and poor heart health. It often lacks important nutrients found in healthier diets. Compared to the Mediterranean diet, the TAD generally proves less effective in improving health related to obesity. ^{1 2 4 6 7}

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]

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]

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]

Citations

1. dietaryguidelines.gov dietaryguidelines.gov/sites/default/files/2020-12/Dietary_Guidelines_for_Americans_2020-2025.pdf

2020-2025 The Dietary Guidelines for Americans, 2020-2025, are available at DietaryGuidelines.gov. They are the 9th edition, published in December 2020.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10410395/

Adherence to a priori dietary patterns in relation to obesity Following DASH or the 2015–2020 DGA was associated with a lower likelihood of obesity. Findings do not indicate causation, as the data are cross-sectional.

3. nesr.usda.gov nesr.usda.gov/sites/default/files/2024-12/Dietary-patterns_growth-obesity-2025DGACSystematicReview_0.pdf

Dietary Patterns and Growth-Risk of Obesity ... Dietary Guidelines for Americans, 2025-2030. The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) appointed the 2025 Dietary ...

4. withpower.com withpower.com/trial/phase-body-weight-9-2021-40639

DGA Diet Patterns for Obesity (DGA4ME Trial) 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S216183132400156X

Environmental and Health Sustainability of the ... The MD showed high nutritional quality, ranging between 122 and 178 points on the health score and between 13.51 and 90.6 points on the nutrient-rich food index ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11661342/

Greater adherence to the Mediterranean diet pattern in the ... Greater adherence to the Mediterranean diet pattern has been consistently associated with reduced risk for adverse cardiometabolic outcomes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299792/

Macronutrient Adequacy of a Mediterranean-type Meal ... Numerous studies have shown that the Mediterranean eating pattern can promote weight loss, however, if combined with caloric restriction as ...