NCT03832933

Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the impact of high protein (HP) vs. normal protein (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity guidance through a group-based weight loss program, State of Slim (SOS). The central hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain and 2) preferentially reducing fat mass while preserving FFM.

Conditions

• Diabetes Type 2
• Obesity
• Diet Modification

Interventions

Type	Name	Description
BEHAVIORAL	High Protein Diet	16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
BEHAVIORAL	Standard Protein Diet	16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2019-02-06
• Last updated: 2022-05-10

Locations

2 sites across 1 country: United States