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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met