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临床试验/NCT01571440
NCT01571440已完成不适用

The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents

Purdue University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年2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
24
试验地点
2
主要终点
Calcium absorption and retention

研究概览

简要总结

The purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls.

详细描述

In a previous study, soluble corn fiber (SCF) was found to greatly enhance calcium utilization and bone properties in a growing rat model. Because factors that enhance bone density and mineral content can potentially result in a skeleton that will resist fracture later in life, it is important to investigate this potential in adolescents. Therefore, the objective of this study was to determine the effect of SCF on calcium absorption and retention in adolescent boys and girls. A second objective of this study was to assess whether additional dietary fiber leads to changes in gut microflora which may influence calcium absorption. During this two-phase metabolic camp participants consumed packages of fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during the first phase of the study, and switch to the opposite treatment during the second phase, with a 2-week washout period in between. Subjects collected all excreta during both phases and calcium absorption, gut microbiota, height, weight, and bone density were evaluated throughout the 6-week period of the study.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Normal, healthy, white adolescents (Hispanic or non-Hispanic)
  • Boys age 13-15
  • Girls age 12-14

排除标准

  • Abnormal kidney or liver function
  • Malabsorptive disorders
  • History of medications that affect calcium metabolism
  • Body weight outside 5-95 percentile body mass index (BMI) for age
  • Regular consumption of illegal drugs
  • Contraceptive use
  • Pregnancy

结局指标

主要结局

Calcium absorption and retention

时间窗: up to three weeks

Gut microbial profile

时间窗: up to three weeks

次要结局

  • Bone mineral content and density(up to three 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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