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OpenTrials
Completed

NCT Number: NCT03318042

Genotype, Metabotype 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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cebas-Csic

Murcia, 30100, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walnuts

Other

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

pomegranate juice

Other

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

Primary outcomes

  1. Polyphenol metabotypes

    Time frame: 1 to 3 months

    Type of ellagic acid-derived microbial metabolites in urine

Secondary outcomes

  1. Genotype

    Time frame: 1 to 6 months

    Detection of 60 SNPs related to obesity, metabolism and cardiovascular disease

  2. Adherence to Mediterranean diet

    Time frame: 1 to 3 months

    Evaluation of the adherence to Mediterranean diet using validated questionnaires

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain)
  • IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)
  • IMDEA Food

Registry information

Official study title

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

Acronym: PolyMicroBio

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2017
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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