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临床试验/NCT03695328
NCT03695328已完成不适用

Effect of Nutrition and Physical Activity on Bone Status in 6-12 Years Children

Democritus University of Thrace0 个研究点目标入组 210 人开始时间: 2015年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
主要终点
Whole body bone mineral density

研究概览

简要总结

Peak bone mass acquisition through childhood and adolescence has been associated with lower risk of osteopenia and osteoporosis in the elderly. The main factors that influence bone mass are the non-modifiable, such as genetics, ethnicity and sex, and the modifiable ones which are nutrition and physical activity or exercise. In the literature are references that demonstrates positive effects of high physical activity, adequate intakes of macro- and micronutrients on bone mass both in adults and in children. Bone mineralization is more adaptive in childrens' growing bones and this is an opportunity for stronger effects by mechanical stimuli during physical activity. The presence of a diet complete of nutrient intakes seems to strengthen the effects of mechanical loads on bone growth and mineralization. The present trial aimed to evaluate the effects of physical activity and nutrition intakes on bone mass in pre-pubertal children.

详细描述

The sample of this study was healthy pre-pubertal boys and girls (N=210) who had training age 0-1 years. Data collection included anthropometric measurements, blood sampling, body composition, bone measurements and physical performance measurements. Nutritional intake was recorded for seven consecutive days in order to evaluate nutrient intakes using an appropriate software and habitual physical activity was measured for the same days using accelerometers. Pubertal stage determined by Tanner scale. All measurements were made only once at the beginning of school year.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

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

入选标准

  • were 6-12 years and pre-pubertal
  • were healthy and had no prior bone fractures or related surgical operation
  • their body fat was <30%, e) had no history of growth irregularities
  • were not receiving agents or drugs that affect bone tissue (e.g. Gonadotropin-Releasing Hormone (GnRH) agonists, antiresorptive, bisphosphonates, etc.)

排除标准

  • had prior bone fractures or related surgical operation
  • their body fat was >30%
  • had history of growth irregularities
  • were receiving agents or drugs that affect bone tissue (e.g. GnRH agonists, antiresorptive, bisphosphonates, etc.)

结局指标

主要结局

Whole body bone mineral density

时间窗: 1 day (Once)

Measured by Dual-X-ray Absoroptiometry

Cardiovascular endurance

时间窗: 1 day (Once)

20m shuttle run test

Body composition

时间窗: 1 day (Once)

Measured by Dual-X-ray Absoroptiometry and skinfolds

Muscular strength

时间窗: 1 day (Once)

Handgrip strength

Flexibility

时间窗: 1 day (Once)

Sit and reach test

Hips bone mineral density

时间窗: 1 day (Once)

Measured by Dual-X-ray Absoroptiometry

Whole body mineral content

时间窗: 1 day (Once)

Measured by Dual-X-ray Absoroptiometry

Lumbar spine bone mineral content

时间窗: 1 day (Once)

Measured by Dual-X-ray Absoroptiometry

Hips bone mineral content

时间窗: 1 day (Once)

Measured by Dual-X-ray Absoroptiometry

Lumbar spine bone mineral density

时间窗: 1 day (Once)

Measured by Dual-X-ray Absoroptiometry

次要结局

  • Serum calcium(1 day (Once))
  • Sclerostin(1 day (Once))
  • Serum vitamin D(1 day (Once))
  • Pubertal Stage(1 day (Once))

研究者

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

KAMBAS ANTONIS

Professor

Democritus University of Thrace

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