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NCT05249166 Clinical Trial

Feeding for Accesible, Affordable and Healthy Childhood

Healthy Children Clinical Trial

— ALINFA  

Official title:
Feeding for Accesible, Affordable and Healthy Childhood

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05249166
Other study ID # ALINFA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date December 10, 2021

Study information
Verified date January 2022
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study was to evaluate the effectiveness of implementing a healthy eating vs traditional recommendations on the Medkid index of children in primary school. To do so, different companies involved in ALINFA project developed with the assessment of UNAV, CNTA and UPNA, a healthy bi-weekly menu.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 10, 2021
Est. primary completion date December 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Adequate cultural level and comprehension of the clinical study from the legal tutors. - To agree in taking part of the study. Exclusion Criteria: - Children presenting clinically relevant gastrointestinal malfunctions or structural anomalies, such as ulcers, chronic inflammatory diseases, etc. Even if they do not follow any pharmacological treatment at the moment of inclusion. - Children with uncontrolled endocrine disorders. - Children with any type of tumor/cancer within the last 5 years, or in current treatment. - Children with any alimentary allergy. - Children presenting any type of cognitive or psychic disorder - Parents or legal tutors in which their future collaboration may not be the required, seen from the researchers' point of view.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ALINFA
Comparing the usual recommendations with the healthy diet designed and developed
• Control
control group

Locations
Country Name City State
Spain Center for Nutrition Research. University of Navarra Pamplona Navarra

Sponsors (3)
Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra Gobierno de Navarra, Universidad Pública de Navarra

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dietary Pattern (questionnaire) Evaluate differences in dietary pattern between groups Baseline
Primary Dietary pattern (questionnaire) Evaluate differences in dietary pattern between groups 8 week
Primary Dietary pattern (questionnaire) Evaluated changes in dietary pattern Baseline vs 8 week
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