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

Genotype, Metabotype and Dietary Habits Clinical Trial

— PolyMicroBio  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318042
• Other study ID #: AGL2015-64124-R(1)
• Status: Completed
• Phase: N/A
• First received: October 18, 2017
• Last updated: October 23, 2017
• Start date: February 1, 2016
• Est. completion date: November 2, 2016

Study information

• Verified date: October 2017
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: November 2, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genotype, Metabotype and Dietary Habits

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Cebas-Csic	Murcia

Sponsors (4)

Lead Sponsor	Collaborator
National Research Council, Spain	CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain), IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain), IMDEA Food

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyphenol metabotypes	Type of ellagic acid-derived microbial metabolites in urine	1 to 3 months
Secondary	Genotype	Detection of 60 SNPs related to obesity, metabolism and cardiovascular disease	1 to 6 months
Secondary	Adherence to Mediterranean diet	Evaluation of the adherence to Mediterranean diet using validated questionnaires	1 to 3 months