Genotype, Metabotype and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
PolyMicroBio
Association Between Genotype, Polyphenol Gut Microbiota Metabotypes, and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
1 other identifier
interventional
423
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2016
CompletedFirst Submitted
Initial submission to the registry
October 18, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedOctober 24, 2017
October 1, 2017
3 months
October 18, 2017
October 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Polyphenol metabotypes
Type of ellagic acid-derived microbial metabolites in urine
1 to 3 months
Secondary Outcomes (2)
Genotype
1 to 6 months
Adherence to Mediterranean diet
1 to 3 months
Study Arms (1)
Child-teenagers-walnuts-pomegranate
EXPERIMENTALIntake of walnuts or pomegranate juice for 3 days
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Healthy individuals aged 5 to 18 years.
- Informed consent signed by the parent / legal representative, and by volunteers who are already 18 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cebas-Csic
Murcia, 30100, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan C. Espin, PhD
Spanish National Research Council (CSIC)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
October 18, 2017
First Posted
October 23, 2017
Study Start
February 1, 2016
Primary Completion
May 1, 2016
Study Completion
November 2, 2016
Last Updated
October 24, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share