Adherence to the Mediterranean DietNCT06361550
Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)
A study testing VENREDI group and Health education in people with Adherence to the Mediterranean Diet, run by University of Salamanca at 1 site in Spain.
Trial summary
Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adherence to the Mediterranean Diet
- What is being tested?
- VENREDI group and Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2023to 30 Dec 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 60 years old, retired or in early retirement
- Participate in the program "Research in active aging with preventive physiotherapy - PReGe"
- Agree to participate in the study and sign the informed consent.
Who cannot join
- Present any pathology that prevents carrying out the workshops appropriately.
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
Rosario Alonso Domínguez
Salamanca, Salamanca, 37007
Rosario Alonso Domínguez, PhD, 0034923294500 ext. 3280, ralonsod@usal.es
About this study
Official title: Effectiveness of a Nutritional Intervention in Improving the Mediterranean Diet in Older Adults
Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Specifically in the elderly population, it has been observed that the Mediterranean diet is inversely associated with all causes of mortality and that the greater the adherence to this type of diet, the lower the mortality in elderly adults.
Objective: To evaluate the effect of a multifactorial intervention (seminar on shopping basket and food labeling, workshop on healthy cooking and subsequent tasting of the prepared products) in improving adherence to the Mediterranean diet in older adults.
Read more
Methodology: Randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be adults over 60 years of age, retired or pre-retired. A sample size of 200 participants has been estimated, 100 in each group to detect a difference of 0.83 points or more in the MEDAS questionnaire.
All participants will receive an educational talk on healthy nutrition, with an estimated duration of 2 hours. The GI, in addition to this educational workshop, will receive a practical seminar on how to properly carry out the shopping cart. This will take place both in a market and later in a supermarket in Salamanca. In addition, a workshop will be held where participants will prepare a menu consisting of three dishes (starter, main and dessert) and will later taste them.
An initial and post-intervention evaluation will be carried out after 3 months so that both groups can study the change variables related to Adherence to the Mediterranean Diet [Mediterranean Diet Adherence Questionnaire (MEDAS)], physical activity [Short physical performance battery (SPPB)], sleep quality (ATENAS questionnaire) and assessment of cognitive function (MOCA questionnaire).
- Conditions
- Adherence to the Mediterranean Diet
- Being tested
- VENREDI group, Health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENREDI groupOther
Practical seminars aimed at improving the Mediterranean diet, guided by researchers.
Health educationOther
Health education on Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Practical seminar, carried out in a market, on how to properly carry out the shopping cart. Afterwards, the participants will prepare a menu, consisting of three courses (starter, main and dessert). Finally, the tasting of the different preparations will take place. Receives: Other: VENREDI group |
| Control | Active comparator | Group educational talk, lasting 2 hours, aimed at correct compliance with the Mediterranean Diet according to current recommendations. Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Mediterranean Diet
Mediterranean Diet Adherence Questionnaire (MEDAS). Minimum [Worse] 0 - Maximum [Better] 14
Measured: Baseline, 3 months
Secondary outcomes (3)
Physical activity
Short Physical Performance Battery. Minimum [Worse] 0 - Maximum [Better] 12
Measured: Baseline, 3 months
Sleep Quality
Atenas questionnaire. Minimum [Better] 0 - Maximum [Worse] 24
Measured: Baseline, 3 months
Cognitive function
MOCA questionnaire. Minimum [Worse] 0 - Maximum [Better] 30
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start2 Nov 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to the Mediterranean DietStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Ayuntamiento de Salamanca
- Responsible party
- Principal investigator, Fausto Jose Barbero-Iglesias, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361550
- Sponsor's protocol ID
- AYTO_SALAMANCA_001
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nutritional Intervention in Improving the Mediterranean Diet in Older Adults
- ClinicalTrials.gov ID
- NCT06361550
- Acronym / sponsor ID
- AYTO_SALAMANCA_001
- Conditions
- Adherence to the Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Ayuntamiento de Salamanca
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Apr 2024 (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.
Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Specifically in the elderly population, it has been observed that the Mediterranean diet is inversely associated with all causes of mortality and that the greater the adherence to this type of diet, the lower the mortality in elderly adults.
Objective: To evaluate the effect of a multifactorial intervention (seminar on shopping basket and food labeling, workshop on healthy cooking and subsequent tasting of the prepared products) in improving adherence to the Mediterranean diet in older adults.
Methodology: Randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be adults over 60 years of age, retired or pre-retired. A sample size of 200 participants has been estimated, 100 in each group to detect a difference of 0.83 points or more in the MEDAS questionnaire.
All participants will receive an educational talk on healthy nutrition, with an estimated duration of 2 hours. The GI, in addition to this educational workshop, will receive a practical seminar on how to properly carry out the shopping cart. This will take place both in a market and later in a supermarket in Salamanca. In addition, a workshop will be held where participants will prepare a menu consisting of three dishes (starter, main and dessert) and will later taste them.
An initial and post-intervention evaluation will be carried out after 3 months so that both groups can study the change variables related to Adherence to the Mediterranean Diet [Mediterranean Diet Adherence Questionnaire (MEDAS)], physical activity [Short physical performance battery (SPPB)], sleep quality (ATENAS questionnaire) and assessment of cognitive function (MOCA questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: VENREDI groupPractical seminar, carried out in a market, on how to properly carry out the shopping cart. Afterwards, the participants will prepare a menu, consisting of three courses (starter, main and dessert). Finally, the tasting of the different preparations will take place. |
| Control | Active comparator | Other: Health educationGroup educational talk, lasting 2 hours, aimed at correct compliance with the Mediterranean Diet according to current recommendations. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be 60 years old, retired or in early retirement
- Participate in the program "Research in active aging with preventive physiotherapy - PReGe"
- Agree to participate in the study and sign the informed consent.
Key exclusion criteria (1 listed)
- Present any pathology that prevents carrying out the workshops appropriately.
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 |
|---|---|---|
| VENREDI groupPractical seminars aimed at improving the Mediterranean diet, guided by researchers. | Other | Intervention group |
| Health educationHealth education on Mediterranean diet | Other | Control |
Primary outcome
Adherence to the Mediterranean Diet
Time frame: Baseline, 3 months
Mediterranean Diet Adherence Questionnaire (MEDAS). Minimum [Worse] 0 - Maximum [Better] 14
3 secondary outcomes
Physical activity
Time frame: Baseline, 3 months
Sleep Quality
Time frame: Baseline, 3 months
Cognitive function
Time frame: Baseline, 3 months
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 26 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Adherence to the Mediterranean Diet
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
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 VENREDI group and Health education in people with Adherence to the Mediterranean Diet, run by University of Salamanca 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 3 inclusion and 1 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 26 Dec 2025. 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?
Contact Rosario Alonso Domínguez, PhD (0034923294500 ext. 3280, ralonsod@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Mediterranean Diet (time frame: Baseline, 3 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 26 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.