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临床试验/NCT03318042
NCT03318042已完成不适用

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

National Research Council, Spain1 个研究点 分布在 1 个国家目标入组 423 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
423
试验地点
1
主要终点
Polyphenol metabotypes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy individuals aged 5 to 18 years.
  • •Informed consent signed by the parent / legal representative, and by volunteers who are already 18 years old.

排除标准

  • •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.

研究组 & 干预措施

Child-teenagers-walnuts-pomegranate

Experimental

Intake of walnuts or pomegranate juice for 3 days

干预措施: Walnuts (Other)

Child-teenagers-walnuts-pomegranate

Experimental

Intake of walnuts or pomegranate juice for 3 days

干预措施: Pomegranate juice (Other)

结局指标

主要结局

Polyphenol metabotypes

时间窗: 1 to 3 months

Type of ellagic acid-derived microbial metabolites in urine

次要结局

  • Genotype(1 to 6 months)
  • Adherence to Mediterranean diet(1 to 3 months)

研究者

发起方
National Research Council, Spain
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Juan Carlos Espín de Gea

Research Professor

National Research Council, Spain

研究点 (1)

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