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Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05649176
Collaborator
National Institute on Aging (NIA) (NIH)
40
Enrollment
2
Arms
28
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diet without soy
  • Other: Diet with soy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled two-arm parallel trialRandomized controlled two-arm parallel trial
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Lifestyle Intervention for Improving Metabolic and Motivational Outcomes
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Insulin sensitivity [12 weeks]

      Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test

    2. Apathy [12 weeks]

      Apathy will be evaluated using the Apathy Evaluation Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Body mass index (BMI) from 30 to 40 kg/m2

    • No evidence of diabetes (fasting blood sugar <126 mg/dL)

    • Mini-Mental State Examination (MMSE) > 25

    • Geriatric Depression Scale-15 (GDS-15) < 6

    • Apathy Evaluation Scale - score > 30

    • Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3

    • Sedentary: < 90 minutes of moderate to vigorous physical activity/week.

    Exclusion Criteria:

    • Prior history of type 2 diabetes.

    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Candida J Rebello, Pennington Biomedical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Candida Rebello, Assistant Professor, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT05649176
    Other Study ID Numbers:
    • PBRC 2022-010
    • 4R00AG065419-03
    First Posted:
    Dec 13, 2022
    Last Update Posted:
    Dec 13, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Insulin Resistance

    Study Results

    No Results Posted as of Dec 13, 2022