Apathy, Insulin Sensitivity
Conditions
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.
Interventions
OTHERDiet 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.
OTHERDiet with soy
The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy.
Sponsors
Pennington Biomedical Research Center
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This is a feeding study. All participants will receive a diet designed to moderate the blood glucose response. The diets will be similar except that in the experimental group soybean flour (soy) will be incorporated into the foods
Intervention model description
Randomized controlled two-arm parallel trial
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity | 12 weeks | Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apathy as assessed by the Apathy Evaluation Scale | 12 weeks | The score on the Apathy Evaluation Scale ranges from 18 to 72 with higher scores indicating greater apathy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCandida J Rebello
Pennington Biomedical Research Center
Outcome results
None listed