- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01686113
Free Fatty Acids: Short Exposure Study
November 20, 2014 updated by: Richard Mattes, Purdue University
This study will examine whether or not short, daily exposures change a person's ability to detect free fatty acids in a solution by its taste.
Repeated exposure should improve a person's ability to detect free fatty acids.
Study Overview
Detailed Description
The possibility that humans can taste non-esterified fatty acids (NEFA) - so-called fat taste - is a relatively new area of research.
Previous work suggests that subjects require an average of between two and three testing sessions of approximately an hour each before they can reliably detect NEFA, and the average number of visits to get the lowest threshold is six.
Streamlining this process is of great interest to researchers who wish to test many people as quickly as possible.
Other taste qualities, including umami and sweet, have shown improvement in detection sensitivity in subjects that have undergone ten second exposures to these taste qualities for 10 days upon subsequent re-testing.
We seek to determine if the same improvements can be seen with fat taste.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
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West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- good health
- available for multiple testing visits
Exclusion Criteria:
- have participated in a fat taste study in the past 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NEFA
Participants swish and spit 5 mL of an oleic acid solution everyday for 10 days.
|
Other Names:
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Active Comparator: Control
Participants swish and spit 5 mL of sucrose solution everyday for 10 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NEFA detection threshold
Time Frame: 10 days
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hunger
Time Frame: 2 days
|
Visual analog scale assessment of hunger level prior to testing
|
2 days
|
BMI
Time Frame: 1 day
|
1 day
|
|
Taste descriptor
Time Frame: 10 days
|
Description of NEFA taste by participant, e.g., sour, bitter, etc.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
September 12, 2012
First Submitted That Met QC Criteria
September 14, 2012
First Posted (Estimate)
September 17, 2012
Study Record Updates
Last Update Posted (Estimate)
November 21, 2014
Last Update Submitted That Met QC Criteria
November 20, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1205012317
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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