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Protein plus exercise: a recipe to rebuild muscle while losing fat in older age?

NCT ID NCT04981366

Disease control Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether adding a daily whey protein supplement to an exercise program helps adults aged 65 and older who have sarcopenic obesity, a condition marked by excess fat and low muscle mass. Participants follow a calorie-restricted diet and either receive whey protein or a calorie-matched placebo supplement. Researchers measure changes in muscle mass, fat mass, and muscle size to see if protein enhances the effects of exercise.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
whey protein supplement (40g daily) compared with an isocaloric (placebo) supplement
What this could lead to
If whey protein adds to exercise and calorie restriction, it could help older adults with sarcopenic obesity preserve muscle while losing fat, improving strength and mobility.
What could go wrong
This is an early-stage trial with 105 participants, so results may not apply broadly. The protein supplement may not outperform the placebo, and any benefit could be modest.

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

105 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2023

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

65 years and older

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: * 65 years and older; * Body mass index (BMI) \> 30 kg/m2; * Sarcopenia; * not engage into exercise training programas. Exclusion Criteria: * cancer in the last 5 years; * cognitive deficit or dementia that impossibility the patient to read and sign the informed consent form; * any disease that limits participation in exercise training program.

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As listed by the trial registrant

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

Aging Sarcopenic obesity

Contacts and locations

Locations

  • University of Sao Paulo

    São Paulo, São Paulo, 05508-030, Brazil

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