Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Study Overview
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Brief Summary
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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: Does the diet and exercise program improve insulin resistance and apathy? 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: A diet to moderate the blood glucose response that contains soybean; and A diet to moderate the blood glucose response that does not contain soybean.

Detailed Description
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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.

Official Title
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Lifestyle Intervention for Improving Metabolic and Motivational Outcomes

Conditions
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Insulin Sensitivity, Apathy

Intervention / Treatment
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* Other: Diet without soy
* Other: Diet with soy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) from 30 to 40 kg/m2 No evidence of diabetes (fasting blood sugar <126 mg/dL) Mini-Mental State Examination (MMSE) > 25 Geriatric Depression Scale-15 (GDS-15) < 6 Apathy Evaluation Scale - score > 30 Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3 Sedentary: < 90 minutes of moderate to vigorous physical activity/week. Exclusion Criteria: Prior history of type 2 diabetes. 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled two-arm parallel trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet without soy<br>Participants receive a diet to moderate the blood glucose response that does not include soy | Other: Diet without soy<br>* The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the experimental diet but does not contain soy.<br>* Other names: Low glycemic index and reduced energy density;|
| Experimental: Diet with soy<br>Participants receive a diet to moderate the blood glucose response that includes soy | Other: Diet with soy<br>* The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy.<br>* Other names: Low glycemic index and reduced energy density;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test | 12 weeks | 
| Apathy | Apathy will be evaluated using the Apathy Evaluation Scale | 12 weeks |