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NCT Number: NCT06361550

Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)

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).

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rosario Alonso Domínguez

Salamanca, 37007, Spain

Location status: Recruiting

Location contact

Rosario Alonso Domínguez, PhD

CONTACT

[email protected]

0034923294500 ext. 3280

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VENREDI group

Other

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

Health education

Other

Health education on Mediterranean diet

Primary outcomes

  1. Adherence to the Mediterranean Diet

    Time frame: Baseline, 3 months

    Mediterranean Diet Adherence Questionnaire (MEDAS). Minimum [Worse] 0 - Maximum [Better] 14

Secondary outcomes

  1. Physical activity

    Time frame: Baseline, 3 months

    Short Physical Performance Battery. Minimum [Worse] 0 - Maximum [Better] 12

  2. Sleep Quality

    Time frame: Baseline, 3 months

    Atenas questionnaire. Minimum [Better] 0 - Maximum [Worse] 24

  3. Cognitive function

    Time frame: Baseline, 3 months

    MOCA questionnaire. Minimum [Worse] 0 - Maximum [Better] 30

Study contacts

Contact information is provided by the study sponsor or research team.

Rosario Alonso Domínguez, PhD

CONTACT

[email protected]

0034923294500 ext. 3280

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Collaborators

  • Ayuntamiento de Salamanca

Registry information

Official study title

Effectiveness of a Nutritional Intervention in Improving the Mediterranean Diet in Older Adults

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.