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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

DGA4ME Trial 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.

DGA4ME Trial 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

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

DGA4ME 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

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation include individuals over the age of thirty?

"As per the study's terms of eligibility, qualified participants must be between 35 and 64 years old."

Answered by AI

How large is the collective of participants engaged in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial was initially listed on August 1st 2022 and has been actively recruiting since then. A total of 168 participants are needed for this study, which is being administered at a single site."

Answered by AI

Who is eligibile to participate in this research experiment?

"This research project is accepting 168 adult participants with a BMI between 27 to 39.9 kg/m2 or body fat percentage of 32-50%. Only individuals aged 35 to 64 will be considered for enrolment."

Answered by AI

Is enrollment open for this research endeavor?

"Confirmed. The details hosted on clinicaltrials.gov suggests that this investigation is currently seeking participants, which was initially announced on August 1st 2022 and last modified on September 8th 2022. A total of 168 people need to be enrolled from a single site."

Answered by AI