Back to resultsFree Fatty Acids: Short Exposure Study
Primary Purpose
Hypogeusia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEFA
Sucrose
Sponsored by
About this trial
This is an interventional basic science trial for Hypogeusia focused on measuring Taste, Fat Taste, Threshold Testing
Eligibility Criteria
Inclusion Criteria:
- good health
- available for multiple testing visits
Exclusion Criteria:
- have participated in a fat taste study in the past 6 months
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NEFA
Control
Arm Description
Participants swish and spit 5 mL of an oleic acid solution everyday for 10 days.
Participants swish and spit 5 mL of sucrose solution everyday for 10 days.
Outcomes
Primary Outcome Measures
NEFA detection threshold
Secondary Outcome Measures
Hunger
Visual analog scale assessment of hunger level prior to testing
BMI
Taste descriptor
Description of NEFA taste by participant, e.g., sour, bitter, etc.
Full Information
NCT ID
NCT01686113
First Posted
September 12, 2012
Last Updated
November 20, 2014
Sponsor
Purdue University
1. Study Identification
Unique Protocol Identification Number
NCT01686113
Brief Title
Free Fatty Acids: Short Exposure Study
Official Title
Free Fatty Acids: Short Exposure Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogeusia
Keywords
Taste, Fat Taste, Threshold Testing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NEFA
Arm Type
Experimental
Arm Description
Participants swish and spit 5 mL of an oleic acid solution everyday for 10 days.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants swish and spit 5 mL of sucrose solution everyday for 10 days.
Intervention Type
Other
Intervention Name(s)
NEFA
Other Intervention Name(s)
Oleic acid
Intervention Type
Other
Intervention Name(s)
Sucrose
Primary Outcome Measure Information:
Title
NEFA detection threshold
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Hunger
Description
Visual analog scale assessment of hunger level prior to testing
Time Frame
2 days
Title
BMI
Time Frame
1 day
Title
Taste descriptor
Description
Description of NEFA taste by participant, e.g., sour, bitter, etc.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good health
available for multiple testing visits
Exclusion Criteria:
have participated in a fat taste study in the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Mattes, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Free Fatty Acids: Short Exposure Study
We'll reach out to this number within 24 hrs