Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

NCT ID: NCT05649176

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2025-10-27

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.

Conditions

Insulin Sensitivity; Apathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Diet without soy

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

Group Type: ACTIVE_COMPARATOR

Diet without soy

Intervention Type: 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.

Diet with soy

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

Group Type: EXPERIMENTAL

Diet with soy

Intervention Type: OTHER

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

Interventions

Diet 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.

Intervention Type: OTHER

Diet with soy

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

Intervention Type: OTHER

Other Intervention Names

Low glycemic index and reduced energy density; Low glycemic index and reduced energy density

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Candida Rebello

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Candida J Rebello

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

References

Solomon TP, Haus JM, Kelly KR, Cook MD, Filion J, Rocco M, Kashyap SR, Watanabe RM, Barkoukis H, Kirwan JP. A low-glycemic index diet combined with exercise reduces insulin resistance, postprandial hyperinsulinemia, and glucose-dependent insulinotropic polypeptide responses in obese, prediabetic humans. Am J Clin Nutr. 2010 Dec;92(6):1359-68. doi: 10.3945/ajcn.2010.29771. Epub 2010 Oct 27.

Reference Type: BACKGROUND

PMID: 20980494 (View on PubMed)

Solomon TP, Haus JM, Kelly KR, Cook MD, Riccardi M, Rocco M, Kashyap SR, Barkoukis H, Kirwan JP. Randomized trial on the effects of a 7-d low-glycemic diet and exercise intervention on insulin resistance in older obese humans. Am J Clin Nutr. 2009 Nov;90(5):1222-9. doi: 10.3945/ajcn.2009.28293. Epub 2009 Sep 30.

Reference Type: BACKGROUND

PMID: 19793849 (View on PubMed)

Other Identifiers

4R00AG065419-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2022-028

Identifier Type: -

Identifier Source: org_study_id