Nutritional Status Assessment and Dietary Recommendations... | NCT06361550

Studies
Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)

NCT06361550

Sponsor

University of Salamanca

Status

Recruiting

Last Update Posted

Dec 26, 2025Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Adherence to the Mediterranean Diet

Interventions

VENREDI group
Health education

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2023Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Apr 3, 2024

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2025

Last Update Posted Date

Dec 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fausto Jose Barbero-Iglesias, Principal investigation, University of SalamancaPrincipal Investigator

Lead Sponsor

University of SalamancaOTHER

Collaborators

Name	Class
Ayuntamiento de Salamanca	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: VENREDI group
Control	Active Comparator	Group educational talk, lasting 2 hours, aimed at correct compliance with the Mediterranean Diet according to current recommendations.	Other: Health education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VENREDI group	Other	Practical seminars aimed at improving the Mediterranean diet, guided by researchers.	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to the Mediterranean Diet	Mediterranean Diet Adherence Questionnaire (MEDAS). Minimum [Worse] 0 - Maximum [Better] 14	Baseline, 3 months

Secondary Outcomes

Measure	Description	Time Frame
Physical activity	Short Physical Performance Battery. Minimum [Worse] 0 - Maximum [Better] 12	Baseline, 3 months
Sleep Quality	Atenas questionnaire. Minimum [Better] 0 - Maximum [Worse] 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rosario Alonso Domínguez, PhD	Contact	0034923294500	3280	ralonsod@usal.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rosario Alonso Domínguez	Recruiting	Salamanca	Salamanca	37007	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided