NCT05649176

Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Lifestyle Intervention for Improving Metabolic and Motivational Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to test the effect of a diet and exercise program in older adults with insulin resistance and a motivation disorder known as apathy. The main questions the study aims to answer are: 1. Does the diet and exercise program improve insulin resistance and apathy? 2. Does the addition of soybean to the diet enhance the effect? Participants will be given all meals for 12 weeks and will exercise under supervision. They will undergo a test of insulin sensitivity and complete questionnaires. Researchers will compare the groups given: 1. A diet to moderate the blood glucose response that contains soybean; and 2. A diet to moderate the blood glucose response that does not contain soybean.

Detailed description

This randomized trial will examine the blood glucose moderating effect of a diet and exercise program in 40 older adults with obesity, insulin resistance, and apathy. The primary objective of this study is to examine the effect of a diet and exercise program on insulin sensitivity and apathy and determine if the addition of soybean to the diet enhances the effect. The primary outcomes of the study are insulin sensitivity measured using the hyperinsulinemic euglycemic clamp test and apathy evaluated using the Apathy Evaluation Scale.

Conditions

• Insulin Sensitivity
• Apathy

Interventions

Type	Name	Description
OTHER	Diet without soy	The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the experimental diet but does not contain soy.
OTHER	Diet with soy	The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy.

Timeline

• Start date: 2023-02-13
• Primary completion: 2025-10-27
• Completion: 2025-10-27
• First posted: 2022-12-13
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States