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.
What safety data exists for the DGA diet patterns for obesity treatment?The provided research does not directly address safety data for the DGA diet patterns, including the Mediterranean diet pattern. The studies focus on adherence to dietary guidelines, potential benefits, and public comprehension, but do not specifically evaluate safety. Therefore, specific safety data for these diet patterns in the context of obesity treatment is not available in the given research.12345
Is the DGA Mediterranean diet pattern a promising treatment for obesity?Yes, the DGA Mediterranean diet pattern is a promising treatment for obesity. It is recommended in the Dietary Guidelines for Americans and is associated with healthier eating habits. This diet focuses on eating more fruits, vegetables, whole grains, and healthy fats, which can help manage weight and improve overall health.12345
What data supports the idea that DGA Diet Patterns for Obesity is an effective treatment?The available research shows that following the Dietary Guidelines for Americans (DGA) diet patterns, like the Mediterranean diet, is linked to healthier outcomes. One study found that sticking to these diets can help manage obesity. Although the research doesn't directly compare the DGA diet to other treatments for obesity, it suggests that these diet patterns are beneficial for overall health. Additionally, the guidelines are designed to prevent chronic diseases, which can be related to obesity.12345
Do I have to stop taking my current medications for the trial?Yes, you will need to stop taking certain medications. The trial excludes participants who are taking medications for elevated lipids, elevated glucose, high blood pressure, weight loss, or conditions requiring corticosteroids. It also excludes those taking antipsychotics or using antibiotics long-term.
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.Treatment Details
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).
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:
๐บ๐ธ Approved in United States as Dietary Guidelines for Americans for:
- General health promotion
- Cardiometabolic risk reduction
- Weight management
๐ช๐บ Approved in European Union as Mediterranean diet pattern for:
- Cardiovascular health
- Type 2 diabetes prevention
- Obesity management
Find a clinic near you
Research locations nearbySelect from list below to view details:
UC Davis, Western Human Nutrition Research CenterDavis, CA
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Who is running the clinical trial?
USDA, Western Human Nutrition Research CenterLead Sponsor
References
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.
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.
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 [...].
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.
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.