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

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

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.

Study Overview

• Status: Completed
• Conditions: Genotype, Metabotype and Dietary Habits
• Intervention / Treatment: Other: Walnuts; Other: Pomegranate juice

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 Type: Interventional
• Enrollment (Actual): 423
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30100
    • Cebas-Csic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Child-teenagers-walnuts-pomegranate; Intake of walnuts or pomegranate juice for 3 days

Other: 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; Other Names: Intake of walnuts; 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; 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

Collaborators and Investigators

• Sponsor: National Research Council, Spain
• Collaborators: IMDEA Food; CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain); IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)
• Investigators: Principal Investigator: Juan C. Espin, PhD, Spanish National Research Council (CSIC)

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): November 2, 2016

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AGL2015-64124-R(1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No