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

NCT03318042 — Not applicable, Completed, 423 participants, National Research Council, Spain

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

Registry	NCT03318042, acronym PolyMicroBio
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, screening
Enrollment	423 (Actual)
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
Conditions	Genotype, Metabotype and Dietary Habits
Interventions	Walnuts, Pomegranate juice (Other)
Dates	start 2016-02-01, primary completion 2016-05-01, completion 2016-11-02, first posted 2017-10-23, last updated 2017-10-24
Locations	1 site in Spain

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Child-teenagers-walnuts-pomegranate	Experimental	Other: Walnuts; Other: Pomegranate juice	Intake of walnuts or pomegranate juice for 3 days

Walnuts (Other), also known as Intake of 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 (Other), also known as Intake of 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

+Outcome measures

Primary outcomes

Polyphenol metabotypes [1 to 3 months]: Type of ellagic acid-derived microbial metabolites in urine

Secondary outcomes

Genotype [1 to 6 months]: Detection of 60 SNPs related to obesity, metabolism and cardiovascular disease
Adherence to Mediterranean diet [1 to 3 months]: Evaluation of the adherence to Mediterranean diet using validated questionnaires

+Eligibility

Sex: All, ages: 5 Years to 18 Years, 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.

+Locations (1)

Facility	City	Country	Status
Cebas-Csic	Murcia	Spain

+Investigators

Juan C. Espin, PhD, Principal investigator, Spanish National Research Council (CSIC)

My Notes

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