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

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ClinicalTrials.gov Identifier: NCT03318042
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 24, 2017
Sponsor:
Collaborators:
CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain)
IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)
IMDEA Food
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain

Brief 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.

Condition or disease Intervention/treatment Phase
Genotype, Metabotype and Dietary Habits Other: Walnuts Other: Pomegranate juice Not Applicable

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  (Clinical Trial)
Actual Enrollment : 423 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Association Between Genotype, Polyphenol Gut Microbiota Metabotypes, and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : November 2, 2016

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 Name: 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 Name: Intake of pomegranate juice




Primary Outcome Measures :
  1. Polyphenol metabotypes [ Time Frame: 1 to 3 months ]
    Type of ellagic acid-derived microbial metabolites in urine


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318042


Locations
Spain
Cebas-Csic
Murcia, Spain, 30100
Sponsors and Collaborators
National Research Council, Spain
CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain)
IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)
IMDEA Food
Investigators
Principal Investigator: Juan C. Espin, PhD Spanish National Research Council (CSIC)

Responsible Party: Juan Carlos Espín de Gea, Research Professor, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT03318042     History of Changes
Other Study ID Numbers: AGL2015-64124-R(1)
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No