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Dietary Intervention

Dietary Interventions for Type 2 Diabetes (DG3D-Phase2 Trial)

N/A
Recruiting
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be able to attend all monitoring visits
18-65 years of age
Must not have
No recent or planned bariatric surgery
No recent weight loss (>10 lbs in the last 6 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial will test whether different dietary patterns can impact risk factors for type 2 diabetes among African American adults.

Who is the study for?
This trial is for African American adults aged 18-65 living in Columbia, SC with a BMI of 25-49.9 kg/m2 who are not pregnant, breastfeeding, or planning pregnancy soon. Participants should not be on weight loss programs/medications or have had bariatric surgery and must be free from major health issues, eating disorders, drug/alcohol dependency, thyroid conditions, and diabetes.
What is being tested?
The study tests three different diet patterns over one year to see their effects on healthy eating scores and risk factors for type 2 diabetes: U.S.-Style Eating Pattern, Mediterranean-Style Eating Pattern, and Vegetarian Eating Pattern. Participants will be randomly assigned to one of these diets.
What are the potential side effects?
As this is a dietary intervention study focusing on healthy eating patterns rather than medication or surgical treatments, significant side effects are not expected. However, changes in diet may cause temporary digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can attend all required check-ups.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had, nor am I planning to have, weight loss surgery.
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I have not lost more than 10 pounds in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in HgbA1c
Changes in body weight
Changes in dietary quality
Secondary study objectives
Changes in blood pressure

Trial Design

3Treatment groups
Experimental Treatment
Group I: Vegetarian dietExperimental Treatment1 Intervention
Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains no meat, poultry, or seafood. Compared with the Healthy U.S.-Style Eating Pattern, it contains more soy products, eggs, beans and peas, nuts and seeds, and whole grains.
Group II: US Healthy DietExperimental Treatment1 Intervention
Participants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern is based on the types and amounts of foods Americans typically consume. The main types of food in this eating pattern include a variety of vegetables; fruits; whole grains; fat-free or low-fat dairy; seafood, poultry, meat, and eggs; and nuts, seeds, and soy products.
Group III: Mediterranean dietExperimental Treatment1 Intervention
Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern.

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor
217 Previous Clinical Trials
121,167 Total Patients Enrolled
30 Trials studying Obesity
8,708 Patients Enrolled for Obesity

Media Library

Healthy Mediterranean-Style Eating Pattern (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05254496 — N/A
Obesity Research Study Groups: Vegetarian diet, Mediterranean diet, US Healthy Diet
Obesity Clinical Trial 2023: Healthy Mediterranean-Style Eating Pattern Highlights & Side Effects. Trial Name: NCT05254496 — N/A
Healthy Mediterranean-Style Eating Pattern (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254496 — N/A
~67 spots leftby Dec 2025
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