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临床试验/NCT01660503
NCT01660503已完成不适用

Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents

Purdue University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年6月1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
30
试验地点
2
主要终点
Calcium Absorption

研究概览

简要总结

Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.

详细描述

The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led to the identification of other fermentable carbohydrates which may improve bone balance and bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber (SCF). Already known for its association with improved intestinal health and influence on colonic microflora content, we have been studying the effects of SCF on calcium absorption and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium utilization and bone properties in a growing rat model. Results from this study demonstrated that SCF was capable of increasing bone mineral content, density and bone strength parameters in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a crossover design using a controlled feeding metabolic balance approach. Given these profound changes on calcium absorption and in bone, a logical next step is to study a dose-response effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living adolescents.

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
9 Years 至 13 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Healthy adolescent Caucasian girls between the ages of 12-
  • This population has been chosen because they exhibit higher risk for osteoporosis later in life.

排除标准

  • Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day. This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.
  • History of smoking, alcohol use, illegal or non-prescription drug use
  • History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or hypo-calcemia
  • History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)
  • History of diseases that affect kidney or liver function.
  • Body Mass Index (BMI) less than 5th percentile for age or greater than the 90th percentile for age
  • Having a broken bone within the last 6 months.
  • Regular consumption of foods or supplements containing prebiotics or probiotics
  • History of pregnancy or use of contraceptives

结局指标

主要结局

Calcium Absorption

时间窗: 4 Weeks

The subject will be asked to consume one snack item in the morning and one snack in the evening for four consecutive weeks. After consuming the SCF product for four weeks the teen will come to Purdue University campus for 3 nights and days (e.g. Thursday noon - Sunday noon). They will reside in university residence hall or hotel near campus. Calcium Absorption testing will be done utilizing 43Ca and 44Ca.

次要结局

  • GI microbial changes(4 weeks)

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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