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DGA Diet Patterns for Obesity (DGA4ME Trial)

N/A
Recruiting
Led By Kevin D Laugero, PhD
Research Sponsored by USDA, Western Human Nutrition Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Awards & highlights

Summary

This trial will test whether weight loss is the most important factor in promoting better health, or if it is more important to focus on eating a healthy diet.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments to new foods and potential hunger due to calorie restriction in some groups.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body weight
Secondary outcome measures
Barriers to physical activity
Change in C-reactive protein
Change in Food Choice
+62 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for obesity include dietary modifications, physical activity, behavioral therapy, and sometimes pharmacotherapy or surgery. Dietary modifications, such as those recommended by the Dietary Guidelines for Americans (DGA), focus on nutrient quality and energy restriction. These diets emphasize the consumption of nutrient-dense foods like fruits, vegetables, whole grains, and lean proteins while reducing calorie intake to promote weight loss. The mechanisms of action include improving metabolic health by reducing insulin resistance, lowering blood pressure, and decreasing lipid levels. For obesity patients, these mechanisms are crucial as they help mitigate the risk of comorbid conditions such as type 2 diabetes, cardiovascular disease, and certain cancers, thereby improving overall health and quality of life.
Ileoanal pull-through: a new surgical alternative to ileostomy and a new challenge in diet therapy.Low fat diet versus low carbohydrate diet for management of non-alcohol fatty liver disease: A systematic review.The anti-inflammatory effects of a Mediterranean diet: a review.

Find a Location

Who is running the clinical trial?

USDA, Western Human Nutrition Research CenterLead Sponsor
62 Previous Clinical Trials
20,939 Total Patients Enrolled
14 Trials studying Obesity
846 Patients Enrolled for Obesity
Kevin D Laugero, PhDPrincipal InvestigatorUSDA, Western Human Nutrition Research Center

Media Library

DGA Mediterranean diet pattern Clinical Trial Eligibility Overview. Trial Name: NCT04293224 — N/A
Obesity Research Study Groups: DGA Mediterranean diet pattern, energy balance, DGA Mediterranean diet pattern, negative energy balance, TAD diet pattern
Obesity Clinical Trial 2023: DGA Mediterranean diet pattern Highlights & Side Effects. Trial Name: NCT04293224 — N/A
DGA Mediterranean diet pattern 2023 Treatment Timeline for Medical Study. Trial Name: NCT04293224 — N/A
~13 spots leftby Sep 2024