The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
2019年7月4日 更新者：Maastricht University Medical Center
Effect of Prebiotic Fibre on Intestinal Health and Functioning
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
研究概览
详细说明
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
研究类型
介入性
注册 (实际的)
48
阶段
- 不适用
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
20年 至 50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:
- Overweight to obese men and women (BMI ≥ 25 kg/m2 <35 kg/m2)
- Aged 20-50 years
- Caucasian
- Normal fasting glucose (<6.1 mmol/L.)
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
- Weight stable in last 3 months (±2 kg)
- A low defecation frequency, <4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
- A slow whole gut transit (>35h)
Exclusion Criteria:
- Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
- Regular smokers
- People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
- Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
- Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
- Following a hypocaloric diet
- Gluten intolerance
- Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as
- Straining in >1/4 defecations;
- Lumpy or hard stools in >1/4 defecations;
- Sensation of incomplete evacuation in >1/4 defecations;
- Sensation of anorectal obstruction/blockade in >1/4 defecations
- Manual maneuvers to facilitate >1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
- <3 defecations/week
- Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
- Not to be able to understand the study information
- Blood donation 2 months prior to the study and during the study
- Participation in other studies
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：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day)
|
12 weeks daily intake of 15g of maltodextrin
其他名称：
|
|
实验性的：soluble wheat bran fibre
12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day)
|
12 weeks daily intake of 15g of soluble wheat bran fibre
|
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 |
|---|---|---|
|
Whole gut transit time [hours]
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Whole gut transit time as measured by radio-opaque marker method
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gastric emptying [min]
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Gastric emptying measured by isotope breath test
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Oro-cecal transit time [min]
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Oro-cecal transit time measured by hydrogen breath test
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Defecation frequency (bowel movement per day)
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Defecation frequency as measured via questionnaire
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Energy expenditure
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Energy expenditure measured by indirect calorimetry
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Substrate oxidation
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Fat and carbohydrate oxidation measured by indirect calorimetry
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Adipose tissue gene expression
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Adipose tissue gene expression measured by quantitative real time polymerase chain reaction
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Gut permeability
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Gut permeability as measured by multi sugar assay
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Microbiota composition
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Microbiota composition as measured by illumina sequencing in feces
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Fecal Short chain fatty acid concentrations
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
|
Plasma short chain fatty acid concentrations
大体时间：measured at baseline at week 1 and directly after the 12 week supplementation
|
Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry
|
measured at baseline at week 1 and directly after the 12 week supplementation
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2015年7月1日
初级完成 (实际的)
2016年12月1日
研究完成 (实际的)
2016年12月1日
研究注册日期
首次提交
2015年3月23日
首先提交符合 QC 标准的
2015年7月1日
首次发布 (估计)
2015年7月7日
研究记录更新
最后更新发布 (实际的)
2019年7月8日
上次提交的符合 QC 标准的更新
2019年7月4日
最后验证
2018年10月1日
更多信息
与本研究相关的术语
其他研究编号
- NL52300.068.15
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.
Placebo的临床试验
-
City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
-
Mila (bMotion Technologies)完全的
-
Universidad Autonoma de MadridCentro Universitario La Salle完全的