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Can olive oil and exercise keep older adults on their feet?

NCT ID NCT07829484

NEW Prevention Sponsor: Fundacion Miguel Servet Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a 24-month program of individualized exercise, Mediterranean diet counselling, and daily extra virgin olive oil can improve walking speed and reduce falls in adults aged 75 and older who are frail and at high risk of falling. Participants are randomly assigned to either the full program or exercise alone. The main measure is change in usual walking speed, a key indicator of physical function and fall risk.

What this could mean

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

Active substance
A 24-month program combining the VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling, and 60 mL/day of extra virgin olive oil
What this could lead to
If it works, this could offer a practical, low-cost way to help frail older adults stay mobile and avoid falls, combining exercise, diet counselling, and olive oil.
What could go wrong
The trial is small and relies on participants sticking with exercise and diet changes for two years, which is hard to maintain. Results may not apply to older adults who are less frail or who have different health conditions.

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 140 people

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

Started

Jun 2026

Expected to finish

Jun 2029

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: * Age 75 years or older. * Barthel Index \>60. * Independent ambulation, with or without an assistive device. * At least one frailty criterion according to the Fried frailty phenotype. * High risk of falls, defined by at least one of the following: gait speed \<0.8 m/s; two or more falls in the previous year; one fall requiring medical attention due to trauma; one fall associated with inability to rise independently or suspected syncope; or one fall in the previous year plus at least one frailty criterion. * Availability of a family member or caregiver to assist with the home exercise program. * Willingness to participate in the exercise and extra virgin olive oil supplementation protocol. Exclusion Criteria: * Acute myocardial infarction within the previous 3 months. * Unstable angina. * Uncontrolled cardiac arrhythmias. * Uncontrolled hypertension. * Recent pulmonary embolism. * Fracture within the previous 3 months. * Severe valvular heart disease. * Institutionalization or planned admission to a nursing home. * Inability to complete study follow-up. * Life expectancy of less than 3 months. * Major neurocognitive disorder (Reisberg Global Deterioration Scale ≥5). * Medical contraindication to exercise. * Habitual extra virgin olive oil consumption \>30 mL/day. * Intestinal malabsorption syndrome. * Allergy to nuts, fish, tomatoes, onions, or garlic.

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Conditions

The condition(s) this trial relates to.

Frailty

As listed by the trial registrant

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

Falls Frailty

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, Navarre, Spain

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