NCT05237128

The Lifestyle Education About Nutrition for Diabetes (Legend) Study

Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months. Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Very low-carbohydrate diet	Participants in this arm will be taught to manage their type 2 diabetes using a very low-carbohydrate diet, also called a ketogenic or "keto" diet. This diet involves eating non-starchy vegetables, leafy greens, cheese, meats, berries, nuts, and seeds and avoiding starchy foods like pasta, bread, rice, beans, many fruits, etc. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.
BEHAVIORAL	Moderate-carbohydrate plate-method diet	Participants in this arm will be taught to manage their type 2 diabetes using a plate-method approach. This diet involves eating different categories of foods based on the proportions of a plate, balancing proteins, vegetables, fruits, starches, and fats. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Timeline

• Start date: 2022-03-22
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-02-11
• Last updated: 2025-11-10

Locations

2 sites across 1 country: United States