The Effect of Galactooligosaccharide (GOS) Supplementation on Calcium Absorption and Retention in Female Adolescent Girls
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
- 是
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
0 g galactooligosaccharide added to calcium-containing yogurt beverage
干预措施: Galactooligosaccharide (Dietary Supplement)
5 g Galactooligosaccharide
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
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
Berdine Martin
Research Scientist, Nutrition Science
Purdue University
