Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
2020年1月16日 更新者：Dr. Raylene Reimer、University of Calgary
Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims
The recent dramatic increase in obesity has been linked to a reduction of dietary fibre intake.
We hypothesized that supplementing the diet of overweight and obesity adults with pulse fibre will improve their metabolic status, chiefly defined as greater weight loss.
Other metabolic health improvements may include improved glucose control and reduced inflammatory markers.
研究概览
详细说明
The main objective of our study is to assess the effects of pulse fibre supplementation on weight loss in an overweight and obese adult population.
Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre on weight loss supported by body composition measures.
Secondary objective - To measure glucose control and appetite regulation in overweight and obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use of plasma HbA1c and an oral glucose tolerance test (OGTT).
Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics and fecal short-chain fatty acid and bile acid concentrations.
研究类型
介入性
注册 (实际的)
53
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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Alberta
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Calgary、Alberta、加拿大、T2N 1N4
- University Of Calgary
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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 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males and females
- Age 18 - 70 years
- BMI 25 - 38 kg/m-2
- Stable body weight for at least 3 months prior to the study
Exclusion Criteria:
- Concomitant use of any weight loss medication, diet or exercise regime
- Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering medication, diabetes medications
- Previous bariatric or other intestinal surgeries
- Pregnancy or lactation
- Weight loss > 3 kg within preceding 3 months to enrollment
- Use of bulk laxatives or probiotics/prebiotics supplements
- Antibiotic use in the past month
- Clinically significant cardiovascular or respiratory or liver disease
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Pulse Fibre
The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.
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Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
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安慰剂比较：Control
The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.
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Control biscuit with no yellow pea hull fibre.
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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 |
|---|---|---|
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Change in Fat Mass at 12 Weeks
大体时间：Value at 12 weeks minus value at baseline
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Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.
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Value at 12 weeks minus value at baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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HbA1c at 12 Weeks
大体时间：12 weeks
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Assessed via HbA1c
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12 weeks
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Change in Objective Appetite at 12 Weeks
大体时间：12 weeks minus baseline
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Value at 12 weeks minus baseline energy intake during weighed lunch buffet.
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12 weeks minus baseline
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cholesterol Profile at 12 Weeks
大体时间：12 weeks
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Serum LDL (low density lipoprotein) cholesterol
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12 weeks
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Serum Cytokine at 12 Weeks
大体时间：12 weeks
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Serum cytokine IL-6 measured at 12 weeks
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12 weeks
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Alpha Diversity of Gut Microbiota at 12 Weeks
大体时间：12 weeks
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Gut microbiota alpha diversity measured at 12 weeks as Chao index.
Chao index is an abundance-based estimator of species richness within a sample.
There are no preset minimum and maximum values but scores typically range from 0 to 4000.
A higher score is generally regarded as better.
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12 weeks
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Serum Metabolomics at 12 Weeks
大体时间：12 weeks
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Serum metabolomics measured at 12 weeks using 1H-NMR analysis.
Principal component analysis is used to see if two or more groups of samples separate into distinct clusters.
The principal components generated in this analysis range from 0-100%.
A higher value means that more variability among the samples is explained by this principal component.
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12 weeks
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Fecal Short-chain Fatty Acid Concentrations
大体时间：12 weeks
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Fecal acetate concentration measured at 12 weeks
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12 weeks
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Fecal Bile Acid Concentration
大体时间：12 weeks
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Fecal cholic acid concentration measured at 12 weeks
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12 weeks
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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：Raylene Reimer, PhD, RD、University Of Calgary
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。
一般刊物
- Lambert JE, Parnell JA, Han J, Sturzenegger T, Paul HA, Vogel HJ, Reimer RA. Evaluation of yellow pea fibre supplementation on weight loss and the gut microbiota: a randomized controlled trial. BMC Gastroenterol. 2014 Apr 8;14:69. doi: 10.1186/1471-230X-14-69.
- Lambert JE, Parnell JA, Tunnicliffe JM, Han J, Sturzenegger T, Reimer RA. Consuming yellow pea fiber reduces voluntary energy intake and body fat in overweight/obese adults in a 12-week randomized controlled trial. Clin Nutr. 2017 Feb;36(1):126-133. doi: 10.1016/j.clnu.2015.12.016. Epub 2016 Jan 11.
- Mayengbam S, Lambert JE, Parnell JA, Tunnicliffe JM, Nicolucci AC, Han J, Sturzenegger T, Shearer J, Mickiewicz B, Vogel HJ, Madsen KL, Reimer RA. Impact of dietary fiber supplementation on modulating microbiota-host-metabolic axes in obesity. J Nutr Biochem. 2019 Feb;64:228-236. doi: 10.1016/j.jnutbio.2018.11.003. Epub 2018 Nov 26.
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
2012年10月1日
初级完成 (实际的)
2013年5月1日
研究完成 (实际的)
2018年11月26日
研究注册日期
首次提交
2012年10月23日
首先提交符合 QC 标准的
2012年10月30日
首次发布 (估计)
2012年11月1日
研究记录更新
最后更新发布 (实际的)
2020年1月21日
上次提交的符合 QC 标准的更新
2020年1月16日
最后验证
2020年1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.