Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

NCT05649176 | Completed DMC

• 2 other identifiers: PBRC 2022-0284R00AG065419-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Does the diet and exercise program improve insulin resistance and apathy?
2. 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.
3. 3.A diet to moderate the blood glucose response that contains soybean; and
4. 4.A diet to moderate the blood glucose response that does not contain soybean.

Conditions

Insulin Sensitivity; Apathy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Diet without soy

ACTIVE COMPARATOR

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

Other: Diet without soy

Diet with soy

EXPERIMENTAL

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

Other: Diet with soy

Interventions

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.

Also known as: Low glycemic index and reduced energy density

Diet without soy

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.

Also known as: Low glycemic index and reduced energy density

Diet with soy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• 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.

  PMID: 20980494 BACKGROUND

• 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.

  PMID: 19793849 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Lethargy

Interventions

Diet

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Candida J Rebello

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled two-arm parallel trial

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: February 13, 2023
• Primary Completion: October 27, 2025
• Study Completion: October 27, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)