An interventional study of Flavor additive in Flavor Perception in Normal, Healthy Adults, sponsored by Monell Chemical Senses Center. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Monell Chemical Senses Center · Not applicable, Interventional, and Other
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.
Monell Chemical Senses Center is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
Other: Flavor additive
Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant
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.
Time frame: 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.
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
Time frame: 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
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.
Time frame: 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.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — If individual subject data are shared, the data will be de-identified first (no identifying information will be shared with other researchers).
Ran from Aug 2020 to primary completion in Jun 2021, 9 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Monell Chemical Senses Center