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

Not Applicable

Completed

• Conditions: Genotype, Metabotype and Dietary Habits
• Interventions: Other: Walnuts; Other: Pomegranate juice

• Registration Number: NCT03318042
• Lead Sponsor: National Research Council, Spain

Brief 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.

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.

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2016-05-01
• Study Completion: 2016-11-02
• Status Verified: 2017-10
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-23
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Child-teenagers-walnuts-pomegranate	Pomegranate juice	Intake of walnuts or pomegranate juice for 3 days
Child-teenagers-walnuts-pomegranate	Walnuts	Intake of walnuts or pomegranate juice for 3 days

Primary Outcome Measures

Name	Time	Method
Polyphenol metabotypes	1 to 3 months	Type of ellagic acid-derived microbial metabolites in urine

Secondary Outcome Measures

Name	Time	Method
Genotype	1 to 6 months	Detection of 60 SNPs related to obesity, metabolism and cardiovascular disease
Adherence to Mediterranean diet	1 to 3 months	Evaluation of the adherence to Mediterranean diet using validated questionnaires

Trial Locations

Locations (1)

Cebas-Csic; 🇪🇸 Murcia, Spain