Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2020-08-30
2021-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
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.
Study Groups
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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.
Flavor additive
Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant
Interventions
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Flavor additive
Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant
Eligibility Criteria
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Inclusion Criteria
2. Men and women
3. Age from 21 to 45
Exclusion Criteria
2. Currently active allergies
3. Regular use of medication (over the counter or prescription), except for birth control.
4. 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).
5. Pregnant, nursing, or trying to become pregnant during the study (pregnancy can affect flavor perception)
6. 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.
7. History of taste problems (absent or abnormal sense of taste)
8. 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.
21 Years
45 Years
ALL
Yes
Sponsors
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HVMN (funding; holder of primary Department of Defense STTR contract)
UNKNOWN
Monell Chemical Senses Center
OTHER
Responsible Party
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Paul Wise
Associate Member (equivalent to Associate Professor)
Principal Investigators
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Paul M Wise, PhD
Role: PRINCIPAL_INVESTIGATOR
Monell Chemical Senses Center
Locations
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Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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H92405-19-C-0016
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SUB055AO1PWise
Identifier Type: -
Identifier Source: org_study_id
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