Fiber Longer Term Study on Energy Intake (FLiTS)
2012年3月9日 更新者：Wageningen University
The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake
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.
研究概览
研究类型
介入性
注册 (实际的)
35
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Wageningen、荷兰、7002HD
- Wageningen University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 30年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age: 18-30 year
- BMI: 18.5-25 kg/m2
- Healthy: as judged by the participant
- H2 producer
Exclusion Criteria:
- 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
- Smoking
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：pectin
10 gram high gelling-high viscous fiber, added to a drink
|
15 days 1 daily consumption of a drink with 10g pectin added
|
|
安慰剂比较：control
10g gelatin, added to a drink
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15 days 1 daily consumption of a drink with 10g gelatin added
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Energy intake
大体时间：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.
|
change from placebo after 2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
satiety
大体时间：change from placebo after 1 day and 15 days
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at day 1 and after 15 days of both supplement and placebo intake satiety is measured hourly over 1 day at waking hours.
The change in satiety will be calculated.
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change from placebo after 1 day and 15 days
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fasting glucose
大体时间：change from placebo after day 0, 1 and 15
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at day 0, 1 and day 15 of supplementation period fasting glucose is measured
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change from placebo after day 0, 1 and 15
|
|
fasting insulin
大体时间：change from placebo after day 0, 1 and 15
|
at day 0, 1 and day 15 of supplementation period fasting insulin is measured
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change from placebo after day 0, 1 and 15
|
|
fasting leptin
大体时间：change from placebo after day 0, 1 and 15
|
at day 0, 1 and day 15 of supplementation period fasting leptin is measured
|
change from placebo after day 0, 1 and 15
|
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hydrogen in breath
大体时间：change from placebo after day 2 and 15
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at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours
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change from placebo after day 2 and 15
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energy intake
大体时间：change from placebo after day 0 and 1
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before supplement intake and after 1 day of supplement 1-day ad libitum energy intake is measured.
The change in energy intake will be calculated.
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change from placebo after day 0 and 1
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body weight
大体时间：change from placebo after day 0,1,2,14,15, 16 and 17
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Each day the subject reports to the research center, body weight is measured.
The change in body weight compared to placebo will be calculated.
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change from placebo after day 0,1,2,14,15, 16 and 17
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adverse events
大体时间：daily from day 0 to day 16
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participants will be asked to register adverse events daily in a diary.
They are also asked to report ae's to the researchers.
number and type of AEs after fibre supplements will be compared to number and type of AEs after placebo supplements
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daily from day 0 to day 16
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Edith Feskens, Prof、Wageningen University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年12月1日
初级完成 (实际的)
2012年3月1日
研究完成 (实际的)
2012年3月1日
研究注册日期
首次提交
2011年12月23日
首先提交符合 QC 标准的
2012年2月1日
首次发布 (估计)
2012年2月6日
研究记录更新
最后更新发布 (估计)
2012年3月12日
上次提交的符合 QC 标准的更新
2012年3月9日
最后验证
2012年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.