Flavor Perception in Normal, Healthy AdultsNCT04289454
Sensory Analysis and Taste Modulation of Ketone Esters
A study testing Flavor additive in people with Flavor Perception in Normal, Healthy Adults, run by Monell Chemical Senses Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Flavor Perception in Normal, Healthy Adults
- What is being tested?
- Flavor additive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2020to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health (self report)
- Men and women
- Age from 21 to 45
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19014
About this study
Official title: Ketone Esters for Optimization of Operator Performance in Hypoxia Technical Volume (Sub-project: Sensory Analysis and Taste Modulation of the Ketone Ester)
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.
- Being tested
- Flavor additive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavor additiveOther
Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Flavor additive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start30 Aug 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flavor Perception in Normal, Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subjects design (the same group of subjects will taste model KE drinks with vs. without added flavors), with order counter-balanced.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monell Chemical Senses Center
- Sponsor type
- University, hospital or other
- Collaborators
- HVMN (funding; holder of primary Department of Defense STTR contract)
- Responsible party
- Principal investigator, Paul Wise, Monell Chemical Senses Center
- Investigators
- Paul M Wise, PhD, Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289454
- Sponsor's protocol ID
- SUB055AO1PWise
- Other IDs
- H92405-19-C-0016
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If individual subject data are shared, the data will be de-identified first (no identifying information will be shared with other researchers).
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Esters for Optimization of Operator Performance in Hypoxia Technical Volume (Sub-project: Sensory Analysis and Taste Modulation of the Ketone Ester)
- ClinicalTrials.gov ID
- NCT04289454
- Acronym / sponsor ID
- SUB055AO1PWise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Collaborators
- HVMN (funding; holder of primary Department of Defense STTR contract)
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subjects design (the same group of subjects will taste model KE drinks with vs. without added flavors), with order counter-balanced.
| Arm | Type | Receives |
|---|---|---|
| Effect of flavor modifiers | Other | Other: Flavor additiveIntervention 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health (self report)
- Men and women
- Age from 21 to 45
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavor additiveVarious flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant | Other | Effect of flavor modifiers |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: Undecided. If individual subject data are shared, the data will be de-identified first (no identifying information will be shared with other researchers).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul M Wise, PhD principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavor additive in people with Flavor Perception in Normal, Healthy Adults, run by Monell Chemical Senses Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.