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

Study Overview
=================
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.

Official Title
-----------------
Association Between Genotype, Polyphenol Gut Microbiota Metabotypes, and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.

Conditions
-----------------
Genotype, Metabotype and Dietary Habits

Intervention / Treatment
-----------------
* Other: Walnuts
* Other: Pomegranate juice


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Child-teenagers-walnuts-pomegranate<br>Intake of walnuts or pomegranate juice for 3 days | Other: Walnuts<br>* 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<br>* Other names: Intake of walnuts;Other: Pomegranate juice<br>* 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<br>* Other names: Intake of pomegranate juice;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyphenol metabotypes | Type of ellagic acid-derived microbial metabolites in urine | 1 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype | Detection of 60 SNPs related to obesity, metabolism and cardiovascular disease | 1 to 6 months | 
| Adherence to Mediterranean diet | Evaluation of the adherence to Mediterranean diet using validated questionnaires | 1 to 3 months |