NCT05649176

Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Completed NA Last updated 2 December 2025

What this trial tests

NA trial testing Diet without soy in Insulin Sensitivity in 40 participants. Completed in 27 October 2025.

Timeline

13 February 2023

Primary endpoint
27 October 2025

27 October 2025

Quick facts

Lead sponsor	Pennington Biomedical Research Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	13 February 2023
Primary completion	27 October 2025
Estimated completion	27 October 2025
Sites	1 location across United States

Drugs / interventions tested

• Diet without soy
• Diet with soy

Conditions studied

• Insulin Sensitivity — all drugs for Insulin Sensitivity →
• Apathy — all drugs for Apathy →

Sponsor

Pennington Biomedical Research Center — full company profile →

Who can join

Adults 50 to 75, any sex, with Insulin Sensitivity or Apathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and Tolerability of Whole Soybean Products: A Dose-Escalating Clinical Trial in Older Adults with Obesity.
   Rebello CJ, Boué S, Levy RJ, Puyau R, et al · · 2023 · cited 1× · PMID 37111139 · DOI 10.3390/nu15081920