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Can high-protein diets help older adults lose weight without losing muscle?

NCT ID NCT07446907

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests different weight-loss strategies for adults aged 50 to 75 with obesity. Participants will follow either a high-protein or standard-protein diet for 16 weeks. Those who don't respond well may then receive extra protein supplements or resistance exercise training. The goal is to find the best way to lose weight while preserving muscle mass. The trial plans to enroll 250 people and will track weight and body composition over a year.

What this could mean

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

Active substance
High protein diet counseling, standard protein diet counseling, protein supplement
What this could lead to
If successful, this could point toward a practical, adaptive weight-loss strategy that helps older adults keep muscle while losing fat.
What could go wrong
This is an early-stage behavioral trial with no drug involved, so results may be modest. The study hasn't started recruiting yet, and outcomes depend on participants sticking with the diet and exercise plans.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

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: * Male or female sex * all racial and ethnic groups * BMI: 30-50 kg/m2 * age 50-75 years * postmenopausal status for ≥1 y if female sex Exclusion Criteria: * \<3 months stable use of other medications affecting body weight or appetite * \>450 pounds (due to weight limitations of the DXA) * indication or previous diagnosis of sarcopenia * existing kidney disease * current binge eating disorder, anorexia, or bulimia * untreated hyper- or hypothyroidism, cancer (except basal cell), gastrointestinal disorders affecting food intake or nutrient absorption; any other medical condition, as determined by the study physician, precluding a HP diet and/or daily exercise

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight Sarcopenia

As listed by the trial registrant

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

Obesity / overweight Sarcopenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

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