Dietary Interventions for Type 2 Diabetes
(DG3D-Phase2 Trial)
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants undergo a one-year intervention using revised culturally tailored materials to examine differences in HEI and T2DM risk factors
Follow-up
Participants are monitored for changes in body weight, HgbA1c, blood pressure, and dietary quality
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?
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.
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.
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
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 Mellitus
The 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 ...
4.
diabetesjournals.org
diabetesjournals.org/care/article/42/8/1390/36123/Effects-of-a-Mediterranean-Eating-Plan-on-the-NeedEffects 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 diabetes
2 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 Mellitus
The 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 ...
8.
hsrd.research.va.gov
hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no104&eBriefTitle=Benefits+and+Harms+of+the+Mediterranean+Diet+Compared+to+Other+DietsBenefits 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 ...
9.
nutritionsource.hsph.harvard.edu
nutritionsource.hsph.harvard.edu/healthy-weight/diet-reviews/mediterranean-diet/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 ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.