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NCT Number: NCT05649176

Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

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.

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Key information

Conditions

Insulin Sensitivity Apathy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lethargy Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet without soy

Other

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 names: Low glycemic index and reduced energy density

Diet with soy

Other

The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy.

Other names: Low glycemic index and reduced energy density

Primary outcomes

  1. Insulin sensitivity

    Time frame: 12 weeks

    Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test

  2. Apathy

    Time frame: 12 weeks

    Apathy will be evaluated using the Apathy Evaluation Scale

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Lifestyle Intervention for Improving Metabolic and Motivational Outcomes

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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