Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Lifestyle Intervention for Improving Metabolic and Motivational Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Insulin Sensitivity; Apathy
• Intervention / Treatment: Other: Diet without soy; Other: Diet with soy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amber Dragg, PhD; Phone Number: 12257633050; Email: Amber.Dragg@pbrc.edu
• Study Contact Backup: Name: Candida J Rebello, MD; Phone Number: 12257633159; Email: Candida.Rebello@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Research Center
      • Contact: Candida Rebello, Ph.D.; Phone Number: 225-763-3159; Email: Candida.Rebello@pbrc.edu
      • Contact: Darryl Whitehead, BS; Email: Candida.Rebello@pbrc.edu
      • Principal Investigator: Candida Rebello, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet without soy; Participants receive a diet to moderate the blood glucose response that does not include soy	Other: 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.; Other Names: Low glycemic index and reduced energy density
Experimental: Diet with soy; Participants receive a diet to moderate the blood glucose response that includes soy	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.; Other Names: Low glycemic index and reduced energy density

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Candida J Rebello, Pennington Biomedical Research Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: PBRC 2022-028; 4R00AG065419-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No