Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)

NCT ID: NCT06361550

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2026-12-30

Brief Summary

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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).

Detailed Description

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Conditions

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Adherence to the Mediterranean Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

VENREDI group

Intervention Type OTHER

Practical seminars aimed at improving the Mediterranean diet, guided by researchers.

Control

Group educational talk, lasting 2 hours, aimed at correct compliance with the Mediterranean Diet according to current recommendations.

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type OTHER

Health education on Mediterranean diet

Interventions

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VENREDI group

Practical seminars aimed at improving the Mediterranean diet, guided by researchers.

Intervention Type OTHER

Health education

Health education on Mediterranean diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Present any pathology that prevents carrying out the workshops appropriately.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ayuntamiento de Salamanca

UNKNOWN

Sponsor Role collaborator

University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Fausto Jose Barbero-Iglesias

Principal investigation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rosario Alonso Domínguez

Salamanca, Salamanca, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rosario Alonso Domínguez, PhD

Role: CONTACT

Phone: 0034923294500

Email: [email protected]

Facility Contacts

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Rosario Alonso Domínguez, PhD

Role: primary

Other Identifiers

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AYTO_SALAMANCA_001

Identifier Type: -

Identifier Source: org_study_id