Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Pennington Biomedical Research Center

Status: Completed

Conditions: Apathy; Insulin Sensitivity

Treatments: Other: Diet with soy; Other: Diet without soy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05649176

PBRC 2022-028

4R00AG065419-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Diet without soy

Active Comparator group

Description:

Participants receive a diet to moderate the blood glucose response that does not include soy

Treatment:

Other: Diet without soy

Diet with soy

Experimental group

Description:

Participants receive a diet to moderate the blood glucose response that includes soy

Treatment:

Other: Diet with soy