198 Participants Needed

Dietary Interventions for Type 2 Diabetes

(DG3D-Phase2 Trial)

MW
BT
TD
Overseen ByTaylor Duncan, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently taking weight loss medications.

What data supports the effectiveness of the treatment Healthy Mediterranean-Style Eating Pattern, Healthy U.S.-Style Eating Pattern, Healthy Vegetarian Eating Pattern for Type 2 Diabetes?

Research shows that vegetarian diets can lead to better weight loss and blood sugar control in people with type 2 diabetes compared to standard diets. Additionally, the Mediterranean diet is linked to a lower risk of developing diabetes, and both the Mediterranean and DASH diets are associated with significant reductions in diabetes risk.12345

Is the Mediterranean-style eating pattern safe for humans?

The Mediterranean-style eating pattern is generally considered safe and is associated with health benefits like improved heart health and reduced risk of diabetes. It includes high-quality foods and is recommended as a healthy way of eating.24678

How does the treatment 'Healthy Mediterranean-Style Eating Pattern, Healthy U.S.-Style Eating Pattern, Healthy Vegetarian Eating Pattern' differ from other treatments for Type 2 diabetes?

This treatment focuses on dietary changes rather than medication, emphasizing plant-based foods, healthy fats like olive oil, and moderate consumption of fish and wine. Unlike standard drug treatments, these eating patterns aim to improve blood sugar control and reduce diabetes risk through natural food choices and lifestyle changes.1491011

What is the purpose of this trial?

Based on the findings of our formative work, conduct a one-year intervention among African American Adults using revised culturally tailored materials to examine differences in Healthy Eating Index (HEI) and type 2 diabetes (T2DM) risk factors among participants (n=198) randomized to one of the 3 dietary patterns:1) Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern.

Eligibility Criteria

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.

Inclusion Criteria

You are willing to be randomized to either condition and be re-randomized if non-responsive.
Live in the Columbia, SC area
Be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
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Exclusion Criteria

Should not be pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 12 months, or currently breastfeeding
You should not have an eating disorder. If you do, you will be given information to contact a specific clinic for help.
I have not had, nor am I planning to have, weight loss surgery.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a one-year intervention using revised culturally tailored materials to examine differences in HEI and T2DM risk factors

12 months

Follow-up

Participants are monitored for changes in body weight, HgbA1c, blood pressure, and dietary quality

4 weeks

Treatment Details

Interventions

  • Healthy Mediterranean-Style Eating Pattern
  • Healthy U.S.-Style Eating Pattern
  • Healthy Vegetarian Eating Pattern
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials
233
Recruited
122,000+

References

An Update on the Mediterranean, Vegetarian, and DASH Eating Patterns in People With Type 2 Diabetes. [2021]
Mediterranean-style dietary pattern, reduced risk of metabolic syndrome traits, and incidence in the Framingham Offspring Cohort. [2023]
Vegetarian Diets in the Prevention and Treatment of Type 2 Diabetes. [2015]
Adherence to a Mediterranean-style eating pattern and risk of diabetes in a U.S. prospective cohort study. [2023]
Dietary Patterns and Type 2 Diabetes: A Systematic Literature Review and Meta-Analysis of Prospective Studies. [2023]
A Mediterranean-style eating pattern with lean, unprocessed red meat has cardiometabolic benefits for adults who are overweight or obese in a randomized, crossover, controlled feeding trial. [2023]
Adherence to the Mediterranean diet and nuclear magnetic resonance spectroscopy biomarkers in older individuals at high cardiovascular disease risk: cross-sectional and longitudinal analyses. [2023]
Mediterranean Eating Pattern. [2020]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Natural Products Derived from the Mediterranean Diet with Antidiabetic Activity: from Insulin Mimetic Hypoglycemic to Nutriepigenetic Modulator Compounds. [2020]
Habitual Dietary Patterns, Nutrient Intakes, and Adherence to the Mediterranean Diet among New Zealand Adults: The NZ MED Cross-Sectional Study. [2023]
Adherence to a Mediterranean diet and glycaemic control in Type 2 diabetes mellitus. [2022]
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