Ketone Esters for Optimization of Operator Performance in Hypoxia Technical Volume (Sub-project: Sensory Analysis and Taste Modulation of the Ketone Ester)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Rated intensity profile
研究概览
简要总结
Ketone ester (KE) drinks are sold commercially in the USA and elsewhere (the FDA has accepted a GRAS (generally regarded as safe) notification on the KEs we propose to study). KE drinks can have beneficial effects on metabolism. Unfortunately, KE drinks have a strongly unpleasant flavor which can trigger rejection. The current study will generate data to help inform KE drink formulations with improved flavor. First stage, trained subjects will rate the intensity of various sensation qualities (e.g., bitter, sour, metallic, and astringent) from KE drinks to help understand the nature of the unpleasant flavor and the particular sensory systems involved (e.g., taste vs. smell). Then, subjects will taste KE drinks with and without various flavor modifiers. Subjects will be healthy adults (aged 21-45) without known food allergies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Samples presented will not be identified (there will be no codes or visual cues regarding whether a model drink does or does not contain a flavor modifier). However, true blinding is impossible since flavor will differ between samples.
Investigators will not be blind to sample contents. However, responses will be collected and recorded using an automated computer program, which offers some protection against possible experimenter bias.
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health (self report)
- •Men and women
- •Age from 21 to 45
排除标准
- •Current (or within the last four weeks) acute illness, such as cold or flu
- •Currently active allergies
- •Regular use of medication (over the counter or prescription), except for birth control.
- •Any history of food allergy or sensitivity (particularly to KE drinks or MSG). Any history of sensitivity to 6-Propylthiouracil (bitter compound frequently used to assess individual differences in sensitivity to bitterness).
- •Pregnant, nursing, or trying to become pregnant during the study (pregnancy can affect flavor perception)
- •Chronic illness (any ongoing condition that is serious or required medical monitoring), including kidney problems, liver problems, cardiovascular problems (e.g., heart disease or high blood pressure), diabetes, HIV infection, or other ongoing illness). Diabetes or other metabolic issues could be important for safety as well as quality of data.
- •History of taste problems (absent or abnormal sense of taste)
- •Weigh less than 100 pounds (45.4 kilograms). This is to help ensure that the amount of KE drink consumed remains below the single serving in the GRAS (generally regarded as safe) notice which the FDA has accepted.
研究组 & 干预措施
Effect of flavor modifiers
Intervention in the study: Subjects will taste model KE drinks with (control condition) and without (experimental condition) added flavors. Design is within-subjects (subjects will taste both the experimental and control drinks), with order counter-balanced across subjects.
干预措施: Flavor additive (Other)
结局指标
主要结局
Rated intensity profile
时间窗: Through study completion (up to a year for a given participant, depending on how many drink samples the participant agrees to evaluate). Participants will rate the intensity of about 12 model drink samples during each study visit.
Rated intensity of taste qualities (e.g., sour, bitter) and mouth-feel (astringent) of model drinks, measured using the general Labeled Magnitude Scale (gLMS). In this implementation of the gLMS, scores will range from 0 (or "no sensation") up to 100 ("strongest imaginable sensation"), with higher scores indicating stronger perceived intensity for the sensation in question.
次要结局
- Hedonic response(Through study completion (up to a year for a given participant, depending on how many drink samples the participant agrees to evaluate). Participants will rate the pleasantness of about 12 model drink samples during each study visit.)
- Rated upper GI symptoms(Through study completion (up to a year for a given participant, depending on how many drink samples the participant agrees to evaluate). Participants will rate upper GI symptoms after tasting about 12 model drink samples during each study visit.)
研究者
Paul Wise
Associate Member (equivalent to Associate Professor)
Monell Chemical Senses Center