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Sensory Analysis and Taste Modulation of Ketone Esters

M

Monell Chemical Senses Center

Status

Completed

Conditions

Flavor Perception in Normal, Healthy Adults

Treatments

Other: Flavor additive

Study type

Interventional

Funder types

Other

Identifiers

NCT04289454
H92405-19-C-0016 (Other Grant/Funding Number)
SUB055AO1PWise

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Effect of flavor modifiers
Other group
Description:
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.
Treatment:
Other: Flavor additive

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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