FallsVIVI-OLIVENCT07829484
VIVI-OLIVE: Multicomponent Exercise and Extra Virgin Olive Oil in Older Adults at High Risk of Falls
A study testing VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling and Extra virgin olive oil supplementation in people with Falls and Frailty, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
VIVI-OLIVE is a multicenter randomized clinical trial evaluating whether a 24-month intervention combining an individualized multicomponent exercise program (VIVIFRAIL), Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) can improve physical function and reduce fall… Read more about this study
- Who is it for?
- Ages 75 years and older
- What is being tested?
- VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling and Extra virgin olive oil supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Acute myocardial infarction within the previous 3 months.
- Unstable angina.
- Uncontrolled cardiac arrhythmias.
- Uncontrolled hypertension.
- Recent pulmonary embolism.
- Fracture within the previous 3 months.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre
Álvaro Casas Herrero, +34 606299823, alvaro.casas.herrero@navarra.es
About this study
Official title: Effectiveness of a Combined Physical Exercise and Olive Oil Supplementation Intervention (VIVI-OLIVE) on Fall Risk in Frail Community-Dwelling Patients at High Risk of Falls: A Multicenter Randomized Clinical Trial
VIVI-OLIVE is a multicenter randomized clinical trial evaluating whether a 24-month intervention combining an individualized multicomponent exercise program (VIVIFRAIL), Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) can improve physical function and reduce fall risk in adults aged 75 years or older at high risk of falls.
Participants will be randomly assigned to either the VIVI-OLIVE intervention or a control group following the VIVIFRAIL multicomponent exercise program. The main outcome is change in usual gait speed, which is an indicator of physical function and fall risk in older adults. Other outcomes include intrinsic capacity, functional independence, quality of life, muscle strength and sarcopenia, muscle characteristics, fear of falling, Mediterranean diet adherence, falls and fall-related consequences, and adherence to the study interventions.
Read the detailed description
VIVI-OLIVE is a multicenter, prospective, randomized, parallel-group clinical trial with a 24-month intervention and follow-up period. The study includes community-dwelling adults aged 75 years or older at high risk of falls.
Participants are randomly allocated in a 1:1 ratio to either the intervention group (VIVI-OLIVE) or the control group (VIVIFRAIL). Randomization is stratified by sex and study center using variable block sizes and is implemented through REDCap.
Participants allocated to the VIVI-OLIVE group follow an individualized VIVIFRAIL multicomponent exercise program, receive Mediterranean diet counselling, and consume 60 mL/day of extra virgin olive oil for 24 months. Participants allocated to the control group follow the individualized VIVIFRAIL multicomponent exercise program.
The primary objective is to evaluate the effectiveness of the VIVI-OLIVE intervention on fall risk and physical function, assessed through changes in usual gait speed. Secondary assessments include intrinsic capacity, functional independence, health-related quality of life, muscle strength and sarcopenia, muscle characteristics assessed by musculoskeletal ultrasound, fear of falling, adherence to the Mediterranean diet, falls and fall-related consequences, and adherence to the study interventions.
Participants undergo assessments from baseline through 24 months, with additional follow-up contacts between study visits to monitor falls and relevant clinical events.
- Being tested
- VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling, Extra virgin olive oil supplementation
- Keywords
- Older adults, High Risk of Falls, Multicomponent Exercise, VIVIFRAIL, Mediterranean Diet, Extra Virgin Olive Oil, Gait Speed, Intrinsic Capacity
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVIFRAIL multicomponent exercise programBehavioural
Individualized multicomponent exercise program based on the VIVIFRAIL program, including strength, balance, gait, flexibility, and endurance exercises. The program is adapted to each participant's functional capacity and is performed throughout the 24-month intervention period.
Mediterranean diet counsellingBehavioural
Participants receive individualized dietary counselling based on the Mediterranean diet, supported by nutritional recommendations and educational materials. Dietary adherence is reinforced during study visits throughout the 24-month intervention period.
Extra virgin olive oil supplementationDietary supplement
Participants consume 60 mL/day of extra virgin olive oil (EVOO), equivalent to approximately four tablespoons per day, throughout the 24-month intervention period. EVOO is provided to participants as part of the VIVI-OLIVE intervention.
| Study group | Role | What they receive |
|---|---|---|
| VIVI-OLIVE | Experimental | Participants receive an individualized VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) for 24 months. Receives: Behavioral: VIVIFRAIL multicomponent exercise program; Behavioral: Mediterranean diet counselling; Dietary Supplement: Extra virgin olive oil supplementation |
| VIVIFRAIL | Active comparator | Participants follow an individualized VIVIFRAIL multicomponent exercise program for 24 months. Receives: Behavioral: VIVIFRAIL multicomponent exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in usual gait speed
Change in usual gait speed assessed using the 5-meter gait speed test. Gait speed will be expressed in meters per second (m/s), with lower values indicating poorer physical performance and a higher risk of falls.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Secondary outcomes (20)
Change in physical performance assessed by the Short Physical Performance Battery (SPPB)
Physical performance will be assessed using the Short Physical Performance Battery (SPPB). The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in functional independence assessed by the Barthel Index
Functional independence in activities of daily living will be assessed using the Barthel Index. Higher scores indicate greater independence in activities of daily living.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in health-related quality of life assessed by the EuroQol-5D
Health-related quality of life will be assessed using the Spanish version of the EuroQol-5D (EQ-5D).
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months.
Change in handgrip strength
Handgrip strength will be assessed bilaterally using a handheld dynamometer. Two measurements will be performed for each hand and the mean value will be recorded. Handgrip strength will be expressed in kilograms (kg), with higher values indicating greater muscle strength.
Measured: From baseline to 24 months, according to the study assessment schedule.
Change in sarcopenia status
Sarcopenia status will be assessed using the SARC-F questionnaire, handgrip strength, and the five-repetition chair stand test, according to the study protocol.
Measured: From baseline to 24 months, according to the study assessment schedule.
Change in muscle thickness assessed by musculoskeletal ultrasound
Muscle thickness of the rectus femoris and thenar eminence of the dominant hand will be assessed using musculoskeletal ultrasound. Change in muscle thickness from baseline will be evaluated over the 24-month follow-up.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in fear of falling
Fear of falling will be assessed using the Short Falls Efficacy Scale-International (Short FES-I), with higher scores indicating greater concern about falling.
Measured: From baseline to 24 months, according to the study assessment schedule.
Change in adherence to the Mediterranean diet
Adherence to the Mediterranean diet will be assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS-14). The total score ranges from 0 to 14 points, with higher scores indicating greater adherence to the Mediterranean diet.
Measured: From baseline to 24 months, according to the study assessment schedule.
Falls and fall-related consequences during follow-up
Falls will be prospectively recorded using a falls diary and reviewed during follow-up contacts. The number of falls and fall-related consequences, including fractures and healthcare use, will be recorded.
Measured: Throughout the 24-month follow-up period.
Percentage adherence to the VIVIFRAIL exercise program
Adherence to the VIVIFRAIL multicomponent exercise program will be calculated as the percentage of prescribed exercise sessions completed by each participant: (number of exercise sessions completed / number of exercise sessions prescribed) × 100. Higher percentages indicate greater adherence.
Measured: Throughout the 24-month intervention period.
Change in cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in nutritional status assessed by the Mini Nutritional Assessment (MNA)
Nutritional status will be assessed using the Mini Nutritional Assessment (MNA). The total score ranges from 0 to 14 points, with higher scores indicating better nutritional status. Scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnutrition.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in depressive symptoms assessed by the 15-item Geriatric Depression Scale (GDS-15)
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15). The total score ranges from 0 to 15 points, with higher scores indicating greater depressive symptoms.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional near vision assessed using a simple visual acuity test
Near vision will be assessed at 3 meters using a simple visual acuity test and classified as functional or non-functional. The outcome will be reported as the number of participants classified as having functional near vision.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional distance vision assessed using a simple visual acuity test
Distance vision will be assessed at 6 meters using a simple visual acuity test and classified as functional or non-functional. The outcome will be reported as the number of participants classified as having functional distance vision.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional hearing assessed using the whispered voice test
Hearing will be assessed using the whispered voice test and classified according to the study protocol. The outcome will be reported as the number of participants with functional hearing.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle cross-sectional area assessed by musculoskeletal ultrasound
Muscle cross-sectional area of the rectus femoris and thenar eminence of the dominant hand will be assessed using musculoskeletal ultrasound. Change in muscle cross-sectional area from baseline will be evaluated over the 24-month follow-up.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle echo intensity assessed by musculoskeletal ultrasound
Muscle echo intensity of the rectus femoris and thenar eminence of the dominant hand will be assessed using musculoskeletal ultrasound as a measure of muscle quality. Change in muscle echo intensity from baseline will be evaluated over the 24-month follow-up.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle ultrasound texture parameters
Ultrasound image texture of the rectus femoris and thenar eminence of the dominant hand will be analyzed as a measure of muscle quality. Change in ultrasound texture parameters from baseline will be evaluated over the 24-month follow-up.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Percentage adherence to extra virgin olive oil supplementation
Adherence to extra virgin olive oil supplementation will be assessed in participants assigned to the VIVI-OLIVE intervention group using a daily adherence diary. Participants are prescribed 60 mL of extra virgin olive oil per day. Adherence will be calculated as the percentage of prescribed days on which the daily target of 60 mL is achieved.
Measured: Throughout the 24-month intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start10 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829484
- Sponsor's protocol ID
- ACH_VIVI-OLIVE
- Acronym
- VIVI-OLIVE
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in study publications may be made available upon reasonable request to the corresponding author, subject to approval and compliance with applicable ethical and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Physical Exercise and Olive Oil Supplementation Intervention (VIVI-OLIVE) on Fall Risk in Frail Community-Dwelling Patients at High Risk of Falls: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07829484
- Acronym / sponsor ID
- VIVI-OLIVE / ACH_VIVI-OLIVE
- Keywords
- Older adults, High Risk of Falls, Multicomponent Exercise, VIVIFRAIL, Mediterranean Diet, Extra Virgin Olive Oil, Gait Speed, Intrinsic Capacity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VIVI-OLIVE is a multicenter randomized clinical trial evaluating whether a 24-month intervention combining an individualized multicomponent exercise program (VIVIFRAIL), Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) can improve physical function and reduce fall risk in adults aged 75 years or older at high risk of falls.
Participants will be randomly assigned to either the VIVI-OLIVE intervention or a control group following the VIVIFRAIL multicomponent exercise program. The main outcome is change in usual gait speed, which is an indicator of physical function and fall risk in older adults. Other outcomes include intrinsic capacity, functional independence, quality of life, muscle strength and sarcopenia, muscle characteristics, fear of falling, Mediterranean diet adherence, falls and fall-related consequences, and adherence to the study interventions.
Detailed description
VIVI-OLIVE is a multicenter, prospective, randomized, parallel-group clinical trial with a 24-month intervention and follow-up period. The study includes community-dwelling adults aged 75 years or older at high risk of falls.
Participants are randomly allocated in a 1:1 ratio to either the intervention group (VIVI-OLIVE) or the control group (VIVIFRAIL). Randomization is stratified by sex and study center using variable block sizes and is implemented through REDCap.
Participants allocated to the VIVI-OLIVE group follow an individualized VIVIFRAIL multicomponent exercise program, receive Mediterranean diet counselling, and consume 60 mL/day of extra virgin olive oil for 24 months. Participants allocated to the control group follow the individualized VIVIFRAIL multicomponent exercise program.
The primary objective is to evaluate the effectiveness of the VIVI-OLIVE intervention on fall risk and physical function, assessed through changes in usual gait speed. Secondary assessments include intrinsic capacity, functional independence, health-related quality of life, muscle strength and sarcopenia, muscle characteristics assessed by musculoskeletal ultrasound, fear of falling, adherence to the Mediterranean diet, falls and fall-related consequences, and adherence to the study interventions.
Participants undergo assessments from baseline through 24 months, with additional follow-up contacts between study visits to monitor falls and relevant clinical events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIVI-OLIVE | Experimental | Behavioral: VIVIFRAIL multicomponent exercise program, Behavioral: Mediterranean diet counselling, Dietary Supplement: Extra virgin olive oil supplementationParticipants receive an individualized VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) for 24 months. |
| VIVIFRAIL | Active comparator | Behavioral: VIVIFRAIL multicomponent exercise programParticipants follow an individualized VIVIFRAIL multicomponent exercise program for 24 months. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- Acute myocardial infarction within the previous 3 months.
- Unstable angina.
- Uncontrolled cardiac arrhythmias.
- Uncontrolled hypertension.
- Recent pulmonary embolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVIFRAIL multicomponent exercise programIndividualized multicomponent exercise program based on the VIVIFRAIL program, including strength, balance, gait, flexibility, and endurance exercises. The program is adapted to each participant's functional capacity and is performed throughout the 24-month intervention period. | Behavioural | VIVI-OLIVE, VIVIFRAIL |
| Mediterranean diet counsellingParticipants receive individualized dietary counselling based on the Mediterranean diet, supported by nutritional recommendations and educational materials. Dietary adherence is reinforced during study visits throughout the 24-month intervention period. | Behavioural | VIVI-OLIVE |
| Extra virgin olive oil supplementationParticipants consume 60 mL/day of extra virgin olive oil (EVOO), equivalent to approximately four tablespoons per day, throughout the 24-month intervention period. EVOO is provided to participants as part of the VIVI-OLIVE intervention. | Dietary supplement | VIVI-OLIVE |
Primary outcome
Change in usual gait speed
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in usual gait speed assessed using the 5-meter gait speed test. Gait speed will be expressed in meters per second (m/s), with lower values indicating poorer physical performance and a higher risk of falls.
20 secondary outcomes
Change in physical performance assessed by the Short Physical Performance Battery (SPPB)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in functional independence assessed by the Barthel Index
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in health-related quality of life assessed by the EuroQol-5D
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months.
Change in handgrip strength
Time frame: From baseline to 24 months, according to the study assessment schedule.
Change in sarcopenia status
Time frame: From baseline to 24 months, according to the study assessment schedule.
Change in muscle thickness assessed by musculoskeletal ultrasound
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in fear of falling
Time frame: From baseline to 24 months, according to the study assessment schedule.
Change in adherence to the Mediterranean diet
Time frame: From baseline to 24 months, according to the study assessment schedule.
Falls and fall-related consequences during follow-up
Time frame: Throughout the 24-month follow-up period.
Percentage adherence to the VIVIFRAIL exercise program
Time frame: Throughout the 24-month intervention period.
Change in cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in nutritional status assessed by the Mini Nutritional Assessment (MNA)
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in depressive symptoms assessed by the 15-item Geriatric Depression Scale (GDS-15)
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional near vision assessed using a simple visual acuity test
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional distance vision assessed using a simple visual acuity test
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Number of participants with functional hearing assessed using the whispered voice test
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle cross-sectional area assessed by musculoskeletal ultrasound
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle echo intensity assessed by musculoskeletal ultrasound
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Change in muscle ultrasound texture parameters
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months.
Percentage adherence to extra virgin olive oil supplementation
Time frame: Throughout the 24-month intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in study publications may be made available upon reasonable request to the corresponding author, subject to approval and compliance with applicable ethical and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVIFRAIL multicomponent exercise program, Mediterranean diet counselling and Extra virgin olive oil supplementation in people with Falls and Frailty, run by Fundacion Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in usual gait speed (time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.