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临床试验/NCT01044680
NCT01044680已完成2 期

The Effects of NUTRIOSE®FB Dietary Fiber Supplementation on the Satiety, Body Fat Distribution, and Metabolic Syndrome Biomarkers of Overweight Adult Chinese Men 20-35 Years of Age.

Roquette Freres1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Determinants of metabolic syndrome

研究概览

简要总结

The purpose of this study was to determine the effects of NUTRIOSE® supplementation on body composition, satiety, and determinants of metabolic syndrome in overweight men.

详细描述

Previous trials of fiber supplementation have yielded equivocal results on body composition, satiety, and determinants of metabolic syndrome. This double-blind, randomized, placebo-controlled study was conducted to determine the effects of a proprietary soluble dextrin dietary fiber supplement (NUTRIOSE®) on these parameters in overweight males.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • males 20-35 years
  • body mass index of 24-28 kg/m2
  • current employment and residence at one of three manufacturing plants with a controlled setting and with similar regimented working conditions 7 days a week

排除标准

  • current or recent dietary fiber supplementation
  • use of lipid-lowering/hypertension medication
  • current insulin injection use
  • contraindication to fiber supplements, e.g. Crohn's disease
  • allergy to wheat products
  • recent or current antibiotic use

结局指标

主要结局

Determinants of metabolic syndrome

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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