Sensory Analysis and Taste Modulation of Ketone Esters

NCT04289454 | Completed

• 2 other identifiers: SUB055AO1PWiseH92405-19-C-0016
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Flavor Perception in Normal, Healthy Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Effect of flavor modifiers

OTHER

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

Interventions

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

Effect of flavor modifiers

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monell Chemical Senses Center: lead
• HVMN (funding; holder of primary Department of Defense STTR contract): collaborator

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19014, United States

Location

MeSH Terms

Interventions

Flavoring Agents

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paul M Wise, PhD

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Member (equivalent to Associate Professor)

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

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 28, 2020
• Study Start: August 30, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)