ClinicalTrials.gg
CompletedNCT03318042PolyMicroBioUpdated Oct 24, 2017

Genotype, Metabotype and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.

An interventional study of Walnuts and Pomegranate juice in Genotype, Metabotype and Dietary Habits, sponsored by National Research Council, Spain. Completed at 1 site in Spain. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by National Research Council, Spain · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Feb 2016, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
423
Allocation
Not applicable
Ages
5 Years to 18 Years
Sex
All
01

Study summary

The objective of this study is to investigate the possible association between 60 SNPs related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.

Read the detailed description

The objective of this study is to investigate the possible association between 60 single nucleotide polymorphisms (SNPs) related to obesity, metabolism and cardiovascular disease with the body mass index (BMI), intestinal microbiota related to the metabolism of polyphehnos and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.

The volunteers (n=423) with ages ranging from 5 to 18 years consumed for three days a daily serving of walnuts (30g) and provided a sample of urine (to determine mirobial-derived metabolites from walnut polyphenols) as well as a swab specimen from the inner cheek to provide DNA for further genotyping.

02

Conditions studied

  • Genotype, Metabotype and Dietary Habits

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03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 423 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.

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Lead sponsor

National Research Council, Spain is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy individuals aged 5 to 18 years.
  • signed by the parent / legal representative, and by volunteers who are already 18 years old.

Exclusion criteria

Exclusion Criteria:

  • Known or suspected allergy or intolerance to nuts or pomegranate.
  • Intake of antibiotics 1 month before the start of the study.
  • If the participant could perceive stress or psychological damage due to his participation.
  • Any other circumstance different from previous ones (illness, etc.), according to which it is considered that the intervention in the study may involve some type of affectation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
423 participants (actual)

Study arms

  • Experimental
    Child-teenagers-walnuts-pomegranate

    Intake of walnuts or pomegranate juice for 3 days

    Other: Walnuts · Other: Pomegranate juice

Interventions

  • OtherWalnuts

    The group consumed a daily serving of walnuts (30 g) or 200 mL pomegranate juice for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek

    Also known as: Intake of walnuts

  • OtherPomegranate juice

    Those volunteers who were allergic to nuts consumed 200 mL pomegranate juice daily for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek

    Also known as: Intake of pomegranate juice

06

What researchers measure

Primary outcomes

  1. Polyphenol metabotypes

    Type of ellagic acid-derived microbial metabolites in urine

    Time frame: 1 to 3 months

Secondary outcomes

  1. Genotype

    Detection of 60 SNPs related to obesity, metabolism and cardiovascular disease

    Time frame: 1 to 6 months

  2. Adherence to Mediterranean diet

    Evaluation of the adherence to Mediterranean diet using validated questionnaires

    Time frame: 1 to 3 months

07

Study locations

1 site
  • Cebas-Csic
    Murcia, 30100, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03318042
Lead sponsor
National Research Council, Spain
Collaborators
CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain), IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain), IMDEA Food
Responsible party
Juan Carlos Espín de Gea (Research Professor, National Research Council, Spain) — Principal investigator
First posted
Oct 23, 2017
Start date
Feb 1, 2016
Primary completion
May 1, 2016
Completion
Nov 2, 2016
Last update
Oct 24, 2017

Study contacts

Juan C. Espin, PhD
principal investigator · Spanish National Research Council (CSIC)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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