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临床试验/NCT02895282
NCT02895282已完成不适用

Chronobiology and Childhood Obesity in a Mediterranean Spanish Population (ONTIME-JR: Obesity, Nutrigenomics, Timing, Mediterranean, Junior)

Universidad de Murcia2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
2
主要终点
BMI

研究概览

简要总结

The main objective is to investigate chronobiological aspects of childhood obesity studying the potential relationship between meal patterns and circadian rhythmicity in a cross-sectional sample of obese, overweight and normal weight children/adolescent.

详细描述

Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 y. As consequence, increasingly children and adolescents suffer from elevated blood pressure, impaired glucose tolerance, hyperinsulinemia, dyslipidemia. Obesity has a multifactorial etiology since there are potentially numerous contributors to its development and progression. Chronobiology, the science that studies periodic (cyclic) changes in living organisms, has been recently proposed as a new and promising topic to investigate. Alterations of circadian (24 h oscillations) system may contribute to obesity and its complications development such as high blood pressure, insulin resistance, altered fasting lipid profile. Conversely, in a vicious manner, obesity has been regarded as a fault in the circadian system explainable by the association with imbalances and fluctuations of hormones/genes expressions rhythms under the influence of body weight changes.

Thus, the study will examine changes in circadian rhythmicity over a week period. The primary end point will be to evaluate differences between obese/overweight and non-obese children in chronotypes and the responses of these parameters to meal patterns. In particular, non-invasive measures that are well-established determinants of chronotypes will form the core endpoints for the study. Well designed and age-appropriate questionnaires will provide further information in order to study correlations with eating, sleeping and sedentary/active behaviors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 8-12 years of age
  • Children from schools in the region of Murcia (Spain) who enter voluntarily

排除标准

  • Children who take melatonin or sleep drugs

结局指标

主要结局

BMI

时间窗: At baseline

A key index for relating weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.

次要结局

  • Individual chronotype with the Munich ChronoType Questionnaire(At baseline)
  • Wrist temperature rhythm(At baseline)
  • Rest-activity rhythm(At baseline)
  • Sleeping characteristics with a 7 days dietary record of night time and day time (siesta) information(At baseline)
  • Food variety(At baseline)
  • Glycemic Index(At baseline)
  • Physical activity(Through study completion)
  • Salivary cortisol determinations(At baseline)
  • Salivary melatonin determinations on weekends the 6th and 7th day of the experimental week(At baseline)
  • Total energy intake(At baseline)
  • Macronutrient distribution(At baseline)
  • Food habits with a 7 days dietary record(At baseline)
  • Mediterranean Diet Score(At baseline)
  • Food timing with a 7 days dietary record(At baseline)
  • Light determination(At baseline)
  • DNA collection in saliva(At baseline)
  • Saliva collection for microflora determinations(At baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PROF. MARTA GARAULET AZA

Full professor of University of Murcia

Universidad de Murcia

研究点 (2)

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