Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Not Applicable

Recruiting

• Conditions: Insulin Sensitivity; Apathy
• Interventions: Other: Diet without soy; Other: Diet with soy

• Registration Number: NCT05649176
• Lead Sponsor: Pennington Biomedical Research Center

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Study Start: 2023-02-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Body mass index (BMI) greater than or equal to 30kg/m2
• Mini-Mental State Examination (MMSE) > 25
• Geriatric Depression Scale-15 (GDS-15) < 6
• Apathy Evaluation Scale - score > 30 or GDS-15 Apathy subscale - score ≥ 2
• Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3
• Sedentary: < 90 minutes of moderate to vigorous physical activity/week.

Exclusion Criteria

• Subjects with a diagnosis of Type 2 diabetes received more than five years ago.
• Participants who have type 1 diabetes
• Participants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight.
• Participants who are on concomitant therapy with glucocorticoids.
• Participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction.
• Participants that have had a fluctuation in body weight >5% in the preceding 2 months.
• Any other conditions that may impede testing of the study hypothesis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet without soy	Diet without soy	Participants receive a diet to moderate the blood glucose response that does not include soy
Diet with soy	Diet with soy	Participants receive a diet to moderate the blood glucose response that includes soy

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	12 weeks	Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test
Apathy	12 weeks	Apathy will be evaluated using the Apathy Evaluation Scale

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States