Investigation of the Perception of Protein Fortified Foods and Beverages
2020年2月11日 更新者：Lisa Methven、University of Reading
This study aims to investigate whether protein fortification of foods and beverages causes mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.
研究概览
详细说明
- To investigate, by using protein fortified foods and beverages, whether mucoadhesion to the oral cavity is greater for older adults compared to younger adults and determine whether it is related to salivary flow rate.
- To determine whether protein fortification of foods and beverages causes mouthdrying and whether perception and acceptance are influenced by age and individual differences in saliva flow.
These aims will be investigated using two different models: a liquid model using whey protein and a solid model using protein fortified biscuits and cakes.
研究类型
介入性
注册 (实际的)
84
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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Berkshire
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Reading、Berkshire、英国、R66 6UR
- Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
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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 及以上 (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:
- Age 18-30 years or over 65 years
- Self reported as healthy (no specific disease states)
Exclusion Criteria:
- Cognitively impaired
- Allergies or intolerances that include coeliac disease, lactose or gluten intolerance
- Diabetic
- Had oral surgery
- Had stroke
- Smoker
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：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Solid Model
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Cake and biscuit will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods of rating drying and discrimination tests "which is the stronger in drying")
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实验性的：Liquid Model
Whey Protein Beverages
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Intervention Description: To study the effect of protein denaturation on perception of whey protein beverages using sensory methods (rating drying as well as discrimination tests "which is the stronger in drying").
Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein beverages.
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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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Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)
大体时间：Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year.
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Participants drink whey protein beverages (unheated and heated protein) then after different time points post swallowing (15 seconds to 5 minutes) expectorated saliva is collected to analyse protein for the extent of mucoadhesion)
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Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year.
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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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Mouthdrying from cake
大体时间：At one time point (visit 3) reported at 1 year.
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Perceived mouth drying from protein fortified vanilla cake and control vanilla cake using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
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At one time point (visit 3) reported at 1 year.
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Mouthdrying from biscuits
大体时间：At one time point (visit 2) reported at 1 year.
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Perceived mouth drying from protein fortified lemon biscuits and control lemon biscuit using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
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At one time point (visit 2) reported at 1 year.
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Mouthdrying from whey protein
大体时间：At one time point (visit 1) reported at 1 year.
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Perceived mouth drying from whey protein beverages (unheated and heated whey protein) using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
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At one time point (visit 1) reported at 1 year.
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Saliva Collection
大体时间：Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.)
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Salivary flow rates from unstimulated and stimulated saliva samples.
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Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.)
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Questionnaire
大体时间：At one time point (visit 1) reported at 1 year.
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Dental status and mouth behaviour categorisation via a questionnaire.
Category data (ie participants check boxes that apply).
The dental status questionnaire is adapted from the WHO oral health questionnaire, it indicates where a participant has poor dental status.
The mouth behaviour questionnaire is a validated questionnaire (JMBM, trademarked), we are investigating whether it relates to perception of protein fortified foods.
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At one time point (visit 1) reported at 1 year.
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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。
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
- Bull SP, Hong Y, Khutoryanskiy VV, Parker JK, Faka M, Methven L. Whey protein mouth drying influenced by thermal denaturation. Food Qual Prefer. 2017 Mar;56(Pt B):233-240. doi: 10.1016/j.foodqual.2016.03.008.
- Withers CA, Cook MT, Methven L, Gosney MA, Khutoryanskiy VV. Investigation of milk proteins binding to the oral mucosa. Food Funct. 2013 Nov;4(11):1668-74. doi: 10.1039/c3fo60291e.
- Affoo RH, Foley N, Garrick R, Siqueira WL, Martin RE. Meta-Analysis of Salivary Flow Rates in Young and Older Adults. J Am Geriatr Soc. 2015 Oct;63(10):2142-51. doi: 10.1111/jgs.13652. Epub 2015 Oct 12.
- Gosney M. Are we wasting our money on food supplements in elder care wards? J Adv Nurs. 2003 Aug;43(3):275-80. doi: 10.1046/j.1365-2648.2003.02710.x.
- Kennedy O, Law C, Methven L, Mottram D, Gosney M. Investigating age-related changes in taste and affects on sensory perceptions of oral nutritional supplements. Age Ageing. 2010 Nov;39(6):733-8. doi: 10.1093/ageing/afq104. Epub 2010 Sep 22.
- Withers CA, Lewis MJ, Gosney MA, Methven L. Potential sources of mouth drying in beverages fortified with dairy proteins: A comparison of casein- and whey-rich ingredients. J Dairy Sci. 2014 Mar;97(3):1233-47. doi: 10.3168/jds.2013-7273. Epub 2014 Jan 17.
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 (实际的)
2019年1月7日
初级完成 (实际的)
2019年7月10日
研究完成 (实际的)
2019年7月10日
研究注册日期
首次提交
2018年12月18日
首先提交符合 QC 标准的
2019年1月8日
首次发布 (实际的)
2019年1月10日
研究记录更新
最后更新发布 (实际的)
2020年2月12日
上次提交的符合 QC 标准的更新
2020年2月11日
最后验证
2020年2月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
No personal identification data will be shared.
The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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