Sensory Analysis and Taste Modulation of Ketone Esters

NCT ID: NCT04289454

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-30

Study Completion Date

2021-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Flavor Perception in Normal, Healthy Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Within-subjects design (the same group of subjects will taste model KE drinks with vs. without added flavors), with order counter-balanced.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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Effect of flavor modifiers

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.

Group Type OTHER

Flavor additive

Intervention Type OTHER

Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant

Interventions

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Flavor additive

Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Monell Chemical Senses Center

OTHER

Sponsor Role lead

Responsible Party

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Paul Wise

Associate Member (equivalent to Associate Professor)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul M Wise, PhD

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Locations

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Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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H92405-19-C-0016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SUB055AO1PWise

Identifier Type: -

Identifier Source: org_study_id

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