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

NCT ID: NCT03318042

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2016-11-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Genotype, Metabotype and Dietary Habits

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Child-teenagers-walnuts-pomegranate

Intake of walnuts or pomegranate juice for 3 days

Group Type EXPERIMENTAL

Walnuts

Intervention Type OTHER

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

Pomegranate juice

Intervention Type OTHER

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

Interventions

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Walnuts

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

Intervention Type OTHER

Pomegranate 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

Intervention Type OTHER

Other Intervention Names

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Intake of walnuts Intake of pomegranate juice

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain)

UNKNOWN

Sponsor Role collaborator

IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)

UNKNOWN

Sponsor Role collaborator

IMDEA Food

OTHER

Sponsor Role collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role lead

Responsible Party

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Juan Carlos Espín de Gea

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan C. Espin, PhD

Role: PRINCIPAL_INVESTIGATOR

Spanish National Research Council (CSIC)

Locations

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Cebas-Csic

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AGL2015-64124-R(1)

Identifier Type: -

Identifier Source: org_study_id