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临床试验/NCT01526759
NCT01526759已完成不适用

The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake

Wageningen University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年12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
35
试验地点
2
主要终点
Energy intake

研究概览

简要总结

Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.

The investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.

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

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-30 year
  • BMI: 18.5-25 kg/m2
  • Healthy: as judged by the participant
  • H2 producer

排除标准

  • Weight loss or weight gain of more than 5 kg during the last 2 months
  • Using an energy restricted diet during the last 2 months
  • Lack of appetite for any reason
  • Restrained eater
  • Heavy alcohol use: >5 drinks/day
  • Reported stomach or bowel diseases or disorders (e.g. irritable bowel syndrome)
  • Reported diabetes
  • Reported thyroid disease or any other endocrine disorder
  • Using medication other than birth control, paracetamol, aspirin, hey fever and asthma
  • Antibiotic use <2 months before the study
  • Reported intolerance, allergy, or not liking of the research foods
  • Vegetarian
  • Current dietary fibre supplementation
  • Fasting glucose levels >5.8 mmol/l
  • Experienced any problems with drawing blood in the past
  • Thesis students or employees of the division of Human Nutrition
  • Volunteers who participated in the ProVe study

结局指标

主要结局

Energy intake

时间窗: change from placebo after 2 weeks

after 14 days of both intervention and placebo supplements ad libitum energy intake is measured for 3 days in a row. The change in energy intake will be calculated.

次要结局

  • satiety(change from placebo after 1 day and 15 days)
  • fasting glucose(change from placebo after day 0, 1 and 15)
  • fasting insulin(change from placebo after day 0, 1 and 15)
  • fasting leptin(change from placebo after day 0, 1 and 15)
  • hydrogen in breath(change from placebo after day 2 and 15)
  • energy intake(change from placebo after day 0 and 1)
  • body weight(change from placebo after day 0,1,2,14,15, 16 and 17)
  • adverse events(daily from day 0 to day 16)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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