Sensory Analysis and Taste Modulation of Ketone Esters

Not Applicable

Completed

• Conditions: Flavor Perception in Normal, Healthy Adults
• Interventions: Other: Flavor additive

• Registration Number: NCT04289454
• Lead Sponsor: Monell Chemical Senses Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Study Start: 2020-08-30
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Good general health (self report)
2. Men and women
3. Age from 21 to 45

Exclusion Criteria

1. Current (or within the last four weeks) acute illness, such as cold or flu
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Effect of flavor modifiers	Flavor additive	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.

Primary Outcome Measures

Name	Time	Method
Rated intensity profile	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.

Secondary Outcome Measures

Name	Time	Method
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.	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
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.	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.

Trial Locations

Locations (1)

Monell Chemical Senses Center; 🇺🇸 Philadelphia, Pennsylvania, United States