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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different diets affect risk factors for type 2 diabetes in African American adults. Participants will be randomly assigned to follow one of three eating patterns: a Healthy U.S.-Style Eating Pattern, a Mediterranean-Style Eating Pattern, or a Vegetarian Eating Pattern. The researchers aim to determine which diet most effectively improves healthy eating habits and reduces diabetes risk factors. Ideal candidates have a body mass index (BMI) between 25 and 49.9, identify as African American, live near Columbia, SC, and do not have major health issues like diabetes or thyroid conditions. As an unphased trial, this study provides a unique opportunity to contribute to significant research on diet and diabetes risk.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the eating patterns under study, such as the Mediterranean, U.S.-Style, and Vegetarian diets, are generally safe and easy for most people to follow. Studies have found that the Mediterranean diet can help control blood sugar and lower the risk of heart problems, including heart attacks.

The Healthy U.S.-Style Eating Pattern emphasizes a balanced diet with vegetables, fruits, and lean proteins. Research suggests this approach can reduce unhealthy fat and sodium intake, leading to better overall health.

For the Vegetarian diet, studies indicate it can lower the risk of developing type 2 diabetes and is associated with lower blood sugar levels and fewer diabetes-related health issues.

These diets adhere to general healthy eating guidelines and have been researched for their health benefits, suggesting they are safe and beneficial for most people.12345

Why are researchers excited about this trial?

Researchers are excited about these dietary interventions for Type 2 Diabetes because they offer a personalized approach to managing the condition through diet. Unlike standard treatments that often focus on medication like metformin or insulin to control blood sugar levels, these diets emphasize natural food patterns that can potentially improve overall health. The Mediterranean diet stands out for its higher intake of fruits and seafood, promoting heart health. The Vegetarian diet boosts plant-based protein and fiber intake, which can aid in weight management and glucose control. Meanwhile, the Healthy U.S.-Style Eating Pattern offers a balanced mix of typical American foods, ensuring a well-rounded nutrient intake. These diverse dietary approaches could lead to an innovative, non-pharmacological strategy for managing Type 2 Diabetes.

What evidence suggests that this trial's dietary interventions could be effective for type 2 diabetes?

This trial will compare three dietary interventions for managing type 2 diabetes: the Mediterranean diet, the Healthy U.S.-Style Eating Pattern, and the Healthy Vegetarian Eating Pattern. Research has shown that the Mediterranean diet, one of the diets tested in this trial, can lower blood sugar levels and improve heart health in people with type 2 diabetes. Studies have found that following this diet may reduce the risk of developing diabetes by up to 23%. The Healthy U.S.-Style Eating Pattern, another diet under study, links to healthier eating habits, such as consuming less unhealthy fats and salt, which can help manage diabetes. For the Healthy Vegetarian Eating Pattern, also tested in this trial, research indicates it can improve blood sugar control and aid in weight loss, both important for managing diabetes. All three diets have shown potential benefits for those with type 2 diabetes.26789

Are You a Good Fit for This Trial?

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
See 8 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Vegetarian dietExperimental Treatment1 Intervention
Group II: US Healthy DietExperimental Treatment1 Intervention
Group III: Mediterranean dietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials
233
Recruited
122,000+

Citations

Mediterranean Diet Effects on Type 2 Diabetes Prevention ...It indicated that in diabetic patients, adherence to the Mediterranean diet was associated with lower HbA1c levels and a better profile of cardiovascular risk ...
Mediterranean Diet and Type 2 Diabetes MellitusThe gathered data conclusively showed that the Mediterranean diet was associated with better glycemic control and cardiovascular risk factors ...
Mediterranean diet in type 2 diabetes: An updated ...A large body of evidence indicates that the Mediterranean diet is effective in preventing diabetes and improving both glycemic control and cardiometabolic ...
Effects of a Mediterranean Eating Plan on the Need for ...A Med-EatPlan + EVOO or nuts did not result in a lower rate of insulin initiation after a median follow-up of 5.1 years. ... In addition, no ...
A journey into a Mediterranean diet and type 2 diabetes2 meta-analyses demonstrated that higher adherence to the Mediterranean diet reduced the risk of future diabetes by 19–23%. Conclusions The Mediterranean diet ...
Mediterranean Diet and Type 2 Diabetes MellitusThe gathered data conclusively showed that the Mediterranean diet was associated with better glycemic control and cardiovascular risk factors than the control ...
Comparison of the Mediterranean Diet and Other Therapeutic ...Mediterranean diet at different doses versus other diets or other treatments showed significant improvements in clinical parameters, including ...
Benefits and Harms of the Mediterranean Diet Compared to ...For secondary prevention, data from two trials indicate that assignment to a Mediterranean diet reduces incidence of myocardial infarction, but not other ...
Diet Review: Mediterranean Diet - The Nutrition Source[6] Those who had the highest adherence to a Mediterranean diet showed a 24% lower risk of cardiovascular disease and 23% lower risk of premature death compared ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security