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临床试验/NCT02091349
NCT02091349已完成不适用

Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber

University of Illinois at Urbana-Champaign0 个研究点目标入组 25 人开始时间: 2010年7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
25
主要终点
Fecal bacteria

研究概览

简要总结

The objective of this study is to determine the tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.

详细描述

Soluble fibers have been shown to have many positive effects in humans, including laxation and maintaining gastrointestinal health. It is expected that feeding soluble fibers will decrease protein fermentative end=products while increasing carbohydrate fermenative end-products, and lead to a more beneficial microbial profile. Determination of the effects of nutriose and polydextrose when included as supplemental fiber in a human diet will give insights to its potential to maintain or improve gut health and highlight its use in the food industry.

The object of this study are first to determine the tolerance of soluble fibers polydextrose, inulin and nutriose when provided as supplemental fiber to an existing diet. The second objective is to determine the utilization of polydextrose and nutriose through analyses of fecal samples of fermentative end-products and shifts in microbial populations.

研究设计

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

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • have body mass index (BMI) between 18.5 and 31 kg/m2
  • free of metabolic and gastrointestinal disease

排除标准

  • BMI less than 18.5 or greater than 31 kg/m2
  • presence of metabolic or gastrointestinal diseases

结局指标

主要结局

Fecal bacteria

时间窗: Days 16-21 of each treatment period

Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for analysis of bacterial species present.

Fecal fermentation end products

时间窗: Days 16-21 of each treatment period

Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for fermentation end product analysis (short-chain fatty indoles, ammonia) and dry matter.

次要结局

  • Gastrointestinal Tolerance(Daily during each 21 day treatment period)
  • Daily Stool Characteristics(Daily during each 21 day treatment period)

研究者

申办方类型
Other
责任方
Sponsor

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