Status:
COMPLETED
Sensory Analysis and Taste Modulation of Ketone Esters
Lead Sponsor:
Monell Chemical Senses Center
Collaborating Sponsors:
HVMN (funding; holder of primary Department of Defense STTR contract)
Conditions:
Flavor Perception in Normal, Healthy Adults
Eligibility:
All Genders
21-45 years
Phase:
NA
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 benef...
Eligibility Criteria
Inclusion
- Good general health (self report)
- Men and women
- Age from 21 to 45
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04289454
Start Date
August 30 2020
End Date
June 4 2021
Last Update
March 21 2022
Active Locations (1)
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1
Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States, 19014