Free Fatty Acids: Threshold Repeatability Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Richard Mattes, Purdue University

ClinicalTrials.gov Identifier:

NCT01550120

First received: March 7, 2012

Last updated: November 21, 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:

MedlinePlus related topics: Taste and Smell Disorders

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
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907

Sponsors and Collaborators

Purdue University

Investigators


Principal Investigator:	Richard D Mattes, PhD	Purdue University

More Information


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:	November 21, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Purdue University:


taste fat threshold sensitivity human

ClinicalTrials.gov processed this record on September 27, 2016

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