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

H

Higher Council for Scientific Research (CSIC)

Status

Completed

Conditions

Genotype, Metabotype and Dietary Habits

Treatments

Other: Walnuts
Other: Pomegranate juice

Study type

Interventional

Funder types

Other

Identifiers

NCT03318042
AGL2015-64124-R(1)

Details and patient eligibility

About

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.

Full 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.

Enrollment

423 patients

Sex

All

Ages

5 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

423 participants in 1 patient group

Child-teenagers-walnuts-pomegranate
Experimental group
Description:
Intake of walnuts or pomegranate juice for 3 days
Treatment:
Other: Pomegranate juice
Other: Walnuts

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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