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New study tests Anti-Inflammatory drink to reverse frailty in seniors

NCT ID NCT07182292

Disease control Sponsor: Fundacion Miguel Servet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether combining a home exercise program with a daily anti-inflammatory nutritional supplement (Alisenoc™) can improve physical performance in frail, malnourished adults aged 75 and older. Participants will be randomly assigned to receive either the anti-inflammatory supplement or a standard supplement alongside the same exercise routine. The goal is to see if the special supplement reduces inflammation and helps rebuild strength and mobility over 12 weeks, with follow-ups up to 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
Alisenoc™ (anti-inflammatory nutritional supplement with olive oil polyphenols, omega-3s, leucine, and antioxidants)
What this could lead to
If successful, this could offer a practical, drug-free way to help frail older adults regain strength and independence.
What could go wrong
This is a relatively small, early-stage trial (158 people) testing a supplement, not a drug. Results may not apply to all older adults, and benefits 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

About 158 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2027

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

75 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: * Patient aged ≥ 75 years. * Diagnosis of frailty according to Linda Fried's criteria. * Diagnosis of malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria. * Barthel Index score ≥ 60 points. * Absence of advanced chronic kidney disease (defined as glomerular filtration rate \< 25 mL/min/1.73m²). * Absence of terminal illness as defined by SECPAL (Spanish Society for Palliative Care) criteria. Exclusion Criteria: * Presence of type 1 or type 2 diabetes mellitus with poor metabolic control (HbA1c \> 8% or insulin-dependent). * Oropharyngeal dysphagia to liquids that prevents safe intake of oral supplementation. * Moderate-to-severe cognitive impairment, defined as a score ≥ 5 on the Global Deterioration Scale (GDS) of Reisberg. * Refusal to sign the informed consent by the patient, primary caregiver, or legal representative, or inability to obtain it. * Known allergy or intolerance to any component of the study supplements. * Institutionalized in a long-term care or residential facility.

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Conditions

The condition(s) this trial relates to.

Frailty Malnutrition nutritional deficiency disease

As listed by the trial registrant

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

Frail elderly syndrome Malnutrition elderly

How to take part

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

  1. 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 ↗

  2. A doctor treating you

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