123 Participants Needed

DGA Diet Patterns for Obesity

(DGA4ME Trial)

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Overseen ByBeverly Miller, BS, RDN
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: USDA, Western Human Nutrition Research Center
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?

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.12345

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.12345

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.12345

Who Is on the Research Team?

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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)
See 20 more

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?
3Treatment groups
Experimental Treatment
Group I: TAD diet patternExperimental Treatment1 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 balanceExperimental Treatment1 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 balanceExperimental Treatment1 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:

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Approved in United States as Dietary Guidelines for Americans for:
  • General health promotion
  • Cardiometabolic risk reduction
  • Weight management
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Approved in European Union as Mediterranean diet pattern for:
  • Cardiovascular health
  • Type 2 diabetes prevention
  • Obesity management

Find a Clinic Near You

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.
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.
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.
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

Substitution Modeling Shows Simple Dietary Changes Increase Mediterranean-Style Diet Pattern Scores for US Adults. [2022]
Assessing the Public's Comprehension of Dietary Guidelines: Use of MyPyramid or MyPlate Is Associated with Healthier Diets among US Adults. [2020]
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 (2020-2025): Pulses, Dietary Fiber, and Chronic Disease Risk-A Call for Clarity and Action. [2021]
Adherence to a priori dietary patterns in relation to obesity: results from two cycles of the Canadian National Nutrition Survey. [2023]
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