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Could a special supplement help obese patients shed pounds without losing muscle?

NCT ID NCT06309563

Disease control Sponsor: Istituto Auxologico Italiano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding an essential amino acid supplement (EAA-AC) to a low-calorie, low-protein diet helps people with severe obesity lose weight while keeping muscle mass. Sixty participants aged 45-65 with a BMI over 35 will be randomly assigned to receive either the supplement or a placebo for two weeks. Researchers will measure weight loss, muscle changes, and blood sugar levels.

What this could mean

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

Active substance
essential amino acids and carboxylic acids (EAA-AC) supplement
What this could lead to
If successful, this could point toward a way to lose weight without losing muscle, improving overall health in severe obesity.
What could go wrong
This is a small, early-stage trial with only 60 participants over 2 weeks, so results may not apply widely. The supplement may not work better than diet alone.

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 60 people

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

Started

Aug 2023

Expected to finish

Dec 2026

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

45 to 65 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: \- Obesity (BMI \>35kg/m2) Exclusion Criteria: * Type 2 diabetes mellitus * Renal failure * Heart failure (New York Heart Association NYHA, class IV) * Liver cirrhosis * Neoplasms * Muscular or non-autonomic pathologies * Neurological-neurodegenerative pathologies * Cognitive decline * Non-menopausal women. * Patients who have undergone bariatric surgery in the previous 12 months * Patients on pharmacological treatment for weight loss in the last three weeks * Patients using vitamin and amino acid supplements in the last three weeks * Patients on hormone therapy (e.g. L-thyroxine, testosterone).

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Conditions

The condition(s) this trial relates to.

morbid obesity Weight Loss

As listed by the trial registrant

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

Obesity, morbid Weight loss

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 and phone numbers. 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

  • Istituto Auxologico Italiano, Site Piancavallo

    RECRUITING

    Oggebbio, Verbania, 28921, Italy

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