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Free Fatty Acids: Short Exposure Study

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ClinicalTrials.gov Identifier: NCT01686113
Recruitment Status : Completed
First Posted : September 17, 2012
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Richard Mattes, Purdue University

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 17, 2012
Last Update Posted Date November 21, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
NEFA detection threshold [ Time Frame: 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01686113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
  • Hunger [ Time Frame: 2 days ]
    Visual analog scale assessment of hunger level prior to testing
  • BMI [ Time Frame: 1 day ]
  • Taste descriptor [ Time Frame: 10 days ]
    Description of NEFA taste by participant, e.g., sour, bitter, etc.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Free Fatty Acids: Short Exposure Study
Official Title  ICMJE Free Fatty Acids: Short Exposure Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Hypogeusia
Intervention  ICMJE
  • Other: NEFA
    Other Name: Oleic acid
  • Other: Sucrose
Study Arms  ICMJE
  • Experimental: NEFA
    Participants swish and spit 5 mL of an oleic acid solution everyday for 10 days.
    Intervention: Other: NEFA
  • Active Comparator: Control
    Participants swish and spit 5 mL of sucrose solution everyday for 10 days.
    Intervention: Other: Sucrose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 14, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • good health
  • available for multiple testing visits

Exclusion Criteria:

  • have participated in a fat taste study in the past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686113
Other Study ID Numbers  ICMJE 1205012317
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Mattes, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard D Mattes, PhD Purdue University
PRS Account Purdue University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP