Healthy ChildrenALINFANCT05249166
Feeding for Accesible, Affordable and Healthy Childhood
A study testing ALINFA in people with Healthy Children, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- ALINFA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2021to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adequate cultural level and comprehension of the clinical study from the legal tutors.
- To agree in taking part of the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Center for Nutrition Research. University of Navarra
Pamplona, Navarre, 31008
About this study
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.
- Conditions
- Healthy Children
- Being tested
- ALINFA, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALINFAOther
Comparing the usual recommendations with the healthy diet designed and developed
ControlOther
control group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Subjects assigned to this arm will follow the habitual recommendations to develop skills for a healthy diet. No specific foods or cooking methods will be applied Receives: Other: Control |
| ALINFA group | Experimental | This group will receive, in addition to the usual recommendations, meals, and foods designed to increase the healthiness of the diet. Foods and meals have been designed to increase the fiber content, decrease sugars and saturated fats, and limit salt intake. Receives: Other: ALINFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Pattern (questionnaire)
Evaluate differences in dietary pattern between groups
Measured: Baseline
Dietary pattern (questionnaire)
Evaluate differences in dietary pattern between groups
Measured: 8 week
Dietary pattern (questionnaire)
Evaluated changes in dietary pattern
Measured: Baseline vs 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start15 Mar 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pública de Navarra, Government of Navarra
- Responsible party
- Sponsor
- Investigators
- Santiago Navas Carretero, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249166
- Sponsor's protocol ID
- ALINFA
- Acronym
- ALINFA
- Status last verified
- Jan 2022
- First submitted
- 9 Dec 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding for Accesible, Affordable and Healthy Childhood
- ClinicalTrials.gov ID
- NCT05249166
- Acronym / sponsor ID
- ALINFA / ALINFA
- Conditions
- Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Universidad Pública de Navarra, Government of Navarra
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 21 Feb 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: ControlSubjects assigned to this arm will follow the habitual recommendations to develop skills for a healthy diet. No specific foods or cooking methods will be applied |
| ALINFA group | Experimental | Other: ALINFAThis group will receive, in addition to the usual recommendations, meals, and foods designed to increase the healthiness of the diet. Foods and meals have been designed to increase the fiber content, decrease sugars and saturated fats, and limit salt intake. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adequate cultural level and comprehension of the clinical study from the legal tutors.
- To agree in taking part of the study.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| ALINFAComparing the usual recommendations with the healthy diet designed and developed | Other | ALINFA group |
| Controlcontrol group | Other | Control group |
Primary outcome
Dietary Pattern (questionnaire)
Time frame: Baseline
Evaluate differences in dietary pattern between groups
Dietary pattern (questionnaire)
Time frame: 8 week
Evaluate differences in dietary pattern between groups
Dietary pattern (questionnaire)
Time frame: Baseline vs 8 week
Evaluated changes in dietary pattern
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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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. This study is not recruiting at the moment.
Santiago Navas Carretero, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALINFA in people with Healthy Children, run by Clinica Universidad de Navarra, Universidad de Navarra 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 21 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Pattern (questionnaire) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 21 Feb 2022.