Taste SensitivityNCT01996566
Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic
An observational study of Taste Sensitivity and Fatty Acid Type, run by Purdue University at 1 site in United States.
Trial summary
Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic acids will be explored. Prior work indicates that there may be a learning effect in measuring detection thresholds for free fatty acids. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Taste Sensitivity, Fatty Acid Type
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2015
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals between 18 and 60 years of age from any ethnic background who are in good health and are available for the next three months will be eligible.
Who may be able to join
- 18-60 years of age
- in good health
- available for 3 months
Who cannot join
- Participation in a different fat taste study in previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic acids will be explored. Prior work indicates that there may be a learning effect in measuring detection thresholds for free fatty acids. This study is designed to determine the number of visits necessary to attenuate this learning effect and also to test whether this effect continues across different types of fatty acids or is specific to each fatty acid. This will aid in understanding how many visits are required to obtain reliable data and if less expensive fatty acids can be used to attenuate learning before testing thresholds for more expensive fatty acids.
- Conditions
- Taste Sensitivity, Fatty Acid Type
- Keywords
- taste, non-esterified fatty acids, threshold, sensitivity, human
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral sensitivity to oleic, lauric, linoleic, linolenic and caproic acids measured by the ascending 3 alternative forced choice test as described in American Society and Testing and Methods E679
Thresholds for taste of each fatty acid will be determined using the 3 alternative forced choice test. Participants will taste 3 samples, one of which contains a fatty acid, and select which sample they believe is different. The concentration of fatty acid used will range from very dilute to a maximum of 5%. The test is repeated over the range of concentrations until a participant is able to correctly identify the fatty acid or until the maximum concentration is reached.
Measured: Measured at weekly intervals over 3 months
Secondary outcomes (3)
DNA sequence of potential fatty acid receptors (e.g., CD36, GPR120, GPR48)
Saliva will be collected to analyze any correlations between fatty acid receptor genes and sensitivity.
Measured: This will be collected at the final visit of the study, approximate 2-3 months from participant enrollment depending on how frequently the participant is able to come to the lab
Amount of habitual dietary fat intake
A survey will be administered to determine each participant's habitual dietary fat intake
Measured: Baseline
Measurement of hunger
Participants will rate how hungry they are on a line scale because commencing each study threshold test
Measured: This will be measured at every study visit (21 visits plus 1 screening visit) over the 2-3 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Taste SensitivityStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996566
- Sponsor's protocol ID
- 055-036
- Status last verified
- Oct 2015
- First submitted
- 12 Aug 2013
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Running CA, Mattes RD. Different oral sensitivities to and sensations of short-, medium-, and long-chain fatty acids in humans. Am J Physiol Gastrointest Liver Physiol. 2014 Aug 1;307(3):G381-9. doi: 10.1152/ajpgi.00181.2014. Epub 2014 Jun 12.
PubMed 24924750
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic
- ClinicalTrials.gov ID
- NCT01996566
- Acronym / sponsor ID
- 055-036
- Conditions
- Taste Sensitivity, Fatty Acid Type
- Keywords
- taste, non-esterified fatty acids, threshold, sensitivity, human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Nov 2013 (estimated)
- 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.
Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic acids will be explored. Prior work indicates that there may be a learning effect in measuring detection thresholds for free fatty acids. This study is designed to determine the number of visits necessary to attenuate this learning effect and also to test whether this effect continues across different types of fatty acids or is specific to each fatty acid. This will aid in understanding how many visits are required to obtain reliable data and if less expensive fatty acids can be used to attenuate learning before testing thresholds for more expensive fatty acids.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals between 18 and 60 years of age from any ethnic background who are in good health and are available for the next three months will be eligible.
Key inclusion criteria (3 listed)
- 18-60 years of age
- in good health
- available for 3 months
Key exclusion criteria (1 listed)
- Participation in a different fat taste study in previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral sensitivity to oleic, lauric, linoleic, linolenic and caproic acids measured by the ascending 3 alternative forced choice test as described in American Society and Testing and Methods E679
Time frame: Measured at weekly intervals over 3 months
Thresholds for taste of each fatty acid will be determined using the 3 alternative forced choice test. Participants will taste 3 samples, one of which contains a fatty acid, and select which sample they believe is different. The concentration of fatty acid used will range from very dilute to a maximum of 5%. The test is repeated over the range of concentrations until a participant is able to correctly identify the fatty acid or until the maximum concentration is reached.
3 secondary outcomes
DNA sequence of potential fatty acid receptors (e.g., CD36, GPR120, GPR48)
Time frame: This will be collected at the final visit of the study, approximate 2-3 months from participant enrollment depending on how frequently the participant is able to come to the lab
Amount of habitual dietary fat intake
Time frame: Baseline
Measurement of hunger
Time frame: This will be measured at every study visit (21 visits plus 1 screening visit) over the 2-3 months of the study
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 15 Oct 2015.
- Derived from this study: PubMed 24924750Running CA, Mattes RD. Different oral sensitivities to and sensations of short-, medium-, and long-chain fatty acids in humans. Am J Physiol Gastrointest Liver Physiol. 2014 Aug 1;307(3):G381-9. doi: 10.1152/ajpgi.00181.2014. Epub 2014 Jun 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Taste Sensitivity and Fatty Acid Type, run by Purdue University 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 1 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 15 Oct 2015. 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?
Oral sensitivity to oleic, lauric, linoleic, linolenic and caproic acids measured by the ascending 3 alternative forced choice test as described in American Society and Testing and Methods E679 (time frame: Measured at weekly intervals over 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01996566, which also lists 1 linked publication.
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 15 Oct 2015.