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Diet and exercise program targets apathy and insulin resistance in seniors

NCT ID NCT05649176

Symptom relief Sponsor: Pennington Biomedical Research Center Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tested a 12-week diet and exercise program in 40 older adults with insulin resistance and apathy, a motivation disorder. Participants received all meals and supervised exercise. The goal was to see if the program improves insulin sensitivity and reduces apathy, and whether adding soybean to the diet boosts the effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance Lethargy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

APATHY Insulin sensitivity

Contacts and locations

Locations

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.