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临床试验/NCT02957318
NCT02957318已完成不适用

Effect of Potato Fiber on Appetite and Fecal Fat Excretion

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Subjective appetite sensations

研究概览

简要总结

Results have indicated that some dietary fibers increase fecal fat excretion and particularly viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may contribute to body weight management.

Aim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of secondary endpoints are investigated.

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
Single (Participant)

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

  • Healthy Men
  • BMI between 18.5 and 27.0 kg/m2
  • Age 20-40 years

排除标准

  • Intake of potatoes with main meals more frequent than 4 times per week
  • Chronic diseases (known diabetes, cardiovascular disease, irritable bowels disease, colitis ulcerosa, crohn disease, or other chronic diseases which could affect the results of the present study)
  • Gluten allergy
  • Use of daily prescription medicine (mild analgesics are allowed)
  • Use of lipid-lowering agents (e.g. Becel, HUSK)
  • Use of food supplements of relevance to the study (such as pre- and probiotics)
  • Irregular intake of vitamin /mineral supplements (two weeks prior to and during the entire study period)
  • Elite athletes (>10 hours of strenuous physical activity per week)
  • Blood donation (<1 month before study commencement and during study period)
  • Participation in other clinical studies (<1 month before study commencement and during study period)
  • Inability (physically or psychologically) to comply with the procedures required by the protocol judged by the Investigator

研究组 & 干预措施

FiberBind

Experimental

干预措施: FiberBind (Dietary Supplement)

RG-I fiber

Experimental

干预措施: RG-I fiber (Dietary Supplement)

Placebo

Placebo Comparator

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Subjective appetite sensations

时间窗: Assessed on 3-hour meal test on last day of the 21-day intervention periods

Assessed by visual analogue scales (VAS)

Fecal fat excretion

时间窗: Based on total feces collection the last 3 days of the 21-day intervention periods

次要结局

  • Gastrointestinal symptoms (questionnaire)(on day 1, 7, 14 and 22 of the 21-day intervention periods)
  • Blood pressure(up to 21-day intervention periods)
  • Breath hydrogen(up to 21-day intervention periods)
  • Gut microbiota(Measured in a fresh feces sample from day 19-21 of the intervention periods)
  • Body weight(up to 21-day intervention periods)
  • Ad libitum energy intake(Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods)
  • Fecal energy excretion(Measured based on total feces collection the last 3 days of the 21-day intervention periods)
  • Insulin and glucose(Measured before and after the 21-day intervention periods, and every 30 minutes during the 3-hour meal test on last day of the 21-week intervention periods)
  • Gut permeability marker(Measured before and after the 21-day intervention periods)
  • Gastric emptying rate (w. paracetamol)(Measured every 30 minutes during the 3-hour meal test on last day of the 21-day intervention periods)
  • Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)(Measured before and after the 21-day intervention periods)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Birgitte Raben

Professor

University of Copenhagen

研究点 (2)

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