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Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

NCT05649176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Insulin Sensitivity
  • Apathy

Interventions

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

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Candida J Rebello · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2025-10-27
Completion
2025-10-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649176 on ClinicalTrials.gov