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临床试验/NCT01263847
NCT01263847已完成早期 1 期

The Effect of Galactooligosaccharide (GOS) Supplementation on Calcium Absorption and Retention in Female Adolescent Girls

Purdue University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2009年6月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
31
试验地点
2
主要终点
Calcium Absorption

研究概览

简要总结

The purpose of this study is to determine the effects of galactooligosaccharide (GOS) supplementation on calcium absorption and and gut microbe profiles.

详细描述

Galactooligosaccharides (GOS) have been shown to have positive effects on calcium absorption in animals and postmenopausal women. This study aims to see whether the addition of fiber in the form of GOS to a calcium-containing yogurt drink will increase calcium absorption compared to placebo in a group of girls near menarche. Secondary outcomes are to assess physical fitness and determine the relationship between physical fitness and calcium absorption in adolescent girls as well as assess changes in gut microbiota. During this three phase, randomized, controlled crossover study, participants will consume yogurt drinks supplemented with 0, 2.5 or 5 grams of GOS twice daily for three weeks. Following each three week period, participants will complete a weekend clinical visit to measure calcium absorption. Height, weight, bone density and geometry, calcium absorption, gut microbiota and physical fitness will be measured. Effects of this GOS fiber intervention may help elucidate a mechanism of action for improving bone health with fiber supplementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Female between ages of 10 and 12
  • Calcium intake of 900-1300 mg/d

排除标准

  • Take medication that influences calcium metabolism
  • Any disorder of calcium or bone homeostasis
  • BMI>90th percentile for age
  • Smoking, illegal drug consumption
  • Any gastrointestinal disease (crohn's disease, celiac disease, inflammatory bowel disease)
  • Any disease affecting kidney function
  • Broken bone within last 6 months
  • Dislike of yogurt or yogurt drinks
  • Regular use of foods containing probiotics or prebiotics

研究组 & 干预措施

No Galactooligosaccharide

Placebo Comparator

0 g galactooligosaccharide added to calcium-containing yogurt beverage

干预措施: Galactooligosaccharide (Dietary Supplement)

5 g Galactooligosaccharide

Active Comparator

5 g galactooligosaccharide provided in two calcium-containing yogurt beverage (2.5 g in each drink) per day

干预措施: Galactooligosaccharide (Dietary Supplement)

10 g Galactooligosaccharide

Active Comparator

10 g galactooligosaccharide added to two calcium-containing yogurt beverage (5 g in each drink) per day

干预措施: Galactooligosaccharide (Dietary Supplement)

结局指标

主要结局

Calcium Absorption

时间窗: baseline and 48 h urine and blood

Calcium absorption will be measured using dual isotope methods. Calcium-44(Ca-44) as calcium chloride will be administered in a yogurt drink provided at breakfast along with a roll, butter, jam and juice. A second isotope, Calcium-43 (Ca-43) as calcium chloride will be administered intravenously, one hour after consumption of breakfast. Urine and blood samples will be collected over a period of 48 hours and levels of Ca-44 and Ca-43 will be measured in urine and blood. Levels of Ca-44 and Ca-43 will be expressed as a ratio (Ca-44/Ca-43).

次要结局

  • Change in fecal microbiota(after 3 weeks of product consumption)

研究者

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

Berdine Martin

Research Scientist, Nutrition Science

Purdue University

研究点 (2)

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