What side effects are associated with this type of intervention?

Common treatments for obesity, such as those following the Dietary Guidelines for Americans (DGA) style diet, which emphasize nutrient quality and energy restriction, can have several side effects. These may include nutritional deficiencies if the diet is not well-balanced, gastrointestinal issues like constipation or diarrhea, and psychological effects such as increased stress or anxiety due to dietary restrictions. Rapid weight loss can also sometimes lead to the formation of gallstones. Close monitoring by healthcare providers is essential to manage and mitigate these side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and semaglutide. These medications aid in weight loss and improve cardiometabolic risk factors by reducing appetite, increasing satiety, or decreasing fat absorption. Semaglutide, in particular, has shown significant weight loss and improvement in cardiometabolic health, aligning with the principles of nutrient quality and energy restriction emphasized in the DGA Style Diet.

What other types of research exist?

Promising alternatives to the Dietary Guidelines for Americans (DGA) style diet for obesity patients in 2024 include the Mediterranean diet, which has been shown to reduce the incidence of type 2 diabetes and improve cardiovascular health, and the vegan diet, which has demonstrated benefits in reducing cardiovascular risk factors. Additionally, low-carbohydrate diets have been associated with improvements in weight management and metabolic health.

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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 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.

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in body weight

Secondary study objectives

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.

Do I qualify?Apply below to find out

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.

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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

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