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Free Fatty Acids: Threshold Repeatability Study

This study is currently recruiting participants.
Verified March 2013 by Purdue University
Sponsor:
Information provided by (Responsible Party):
Richard Mattes, Purdue University
ClinicalTrials.gov Identifier:
NCT01550120
First received: March 7, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds change with repeated testing. Threshold testing for NEFA taste has been reported by a number of laboratories, including our own; however, these studies have reported data for only one testing occasion. The investigators seek to conduct repeated testing to measure the test-retest reliability of these methods. The investigators believe that with repeated exposure to NEFA, a person's sensitivity increases. The investigators are also testing the efficiency of testing by two methods (forced-choice ascending trial versus staircase). Additionally, the association between taste responses, diet and BMI will be explored.


Condition
Taste, Non-esterified Fatty Acids

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Free Fatty Acids: Threshold Repeatability Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Non-esterified fatty acid detection thresholds in humans [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Habitual fat intake [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Block Rapid Dietary Fat Screener will be used as well as the ASA-24.

  • testing method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison of time to maximum sensitivity by participants based on forced-choice versus staircase stimulus presentation techniques.

  • hunger [ Time Frame: each visit ] [ Designated as safety issue: No ]
    Visual analog scale


Estimated Enrollment: 48
Study Start Date: March 2012
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants between the ages of 18 and 55 years of age from any ethnic background who are in good health and are available for the next three months will be recruited. Additionally, equal numbers of lean and overweight participants will be sought.

Criteria

Inclusion Criteria:

  • 18-55 years old
  • in good health
  • available for three months

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550120

Contacts
Contact: Richard D Mattes, PhD 765-494-0662 mattes@purdue.edu

Locations
United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Richard D Mattes, PhD     765-494-0662     mattes@purdue.edu    
Principal Investigator: Richard D Mattes, PhD            
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Richard D Mattes, PhD Purdue University
  More Information

No publications provided

Responsible Party: Richard Mattes, Distinguished Professor, Purdue University
ClinicalTrials.gov Identifier: NCT01550120     History of Changes
Other Study ID Numbers: 055-027
Study First Received: March 7, 2012
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
taste
fat
threshold
sensitivity
human

ClinicalTrials.gov processed this record on May 16, 2013