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| ID | Type | Description | Link |
|---|---|---|---|
| H92405-19-C-0016 | Other Grant/Funding Number | SOCOM |
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| Name | Class |
|---|---|
| HVMN (funding; holder of primary Department of Defense STTR contract) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effect of flavor modifiers | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavor additive | Other | Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant |
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| Measure | Description | Time Frame |
|---|---|---|
| Rated intensity profile | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hedonic response | Ratings of how likely the flavor of each sample tasted would be to discourage use of a product with that flavor, assuming the rater otherwise wanted associated nutritional or performance benefits | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul M Wise, PhD | Monell Chemical Senses Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monell Chemical Senses Center | Philadelphia | Pennsylvania | 19014 | United States |
If individual subject data are shared, the data will be de-identified first (no identifying information will be shared with other researchers).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2022 | Mar 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
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Within-subjects design (the same group of subjects will taste model KE drinks with vs. without added flavors), with order counter-balanced.
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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.
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| Rated upper GI symptoms | Rated intensity of nausea, bloating, and heartburn, using a nine-point category scale (some bitter liquids can trigger mild to moderate feelings of nausea). Scores for each symptom range from 0 ("none") to 8 ("Unbearable"), with "mild" (2), "moderate" (4), and "severe" (6) as labeled intermediate categories. | 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. |
| D020313 |
| Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |