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Completed

NCT Number: NCT04289454

Sensory Analysis and Taste Modulation of Ketone Esters

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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Key information

Conditions

Flavor Perception in Normal, Healthy Adults

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good general health (self report)
  • Men and women
  • Age from 21 to 45

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Rated intensity profile

    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.

    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 outcomes

  1. Hedonic response

    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.

    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

  2. Rated upper GI symptoms

    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.

    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.

Sponsors and collaborators

Lead sponsor

Monell Chemical Senses Center

Other

Collaborators

  • HVMN (funding; holder of primary Department of Defense STTR contract)

Registry information

Official study title

Ketone Esters for Optimization of Operator Performance in Hypoxia Technical Volume (Sub-project: Sensory Analysis and Taste Modulation of the Ketone Ester)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.