NCT01996566

Brief Summary

Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic acids will be explored. Prior work indicates that there may be a learning effect in measuring detection thresholds for free fatty acids. This study is designed to determine the number of visits necessary to attenuate this learning effect and also to test whether this effect continues across different types of fatty acids or is specific to each fatty acid. This will aid in understanding how many visits are required to obtain reliable data and if less expensive fatty acids can be used to attenuate learning before testing thresholds for more expensive fatty acids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

August 12, 2013

Last Update Submit

October 14, 2015

Conditions

Keywords

tastenon-esterified fatty acidsthresholdsensitivityhuman

Outcome Measures

Primary Outcomes (1)

  • Oral sensitivity to oleic, lauric, linoleic, linolenic and caproic acids measured by the ascending 3 alternative forced choice test as described in American Society and Testing and Methods E679

    Thresholds for taste of each fatty acid will be determined using the 3 alternative forced choice test. Participants will taste 3 samples, one of which contains a fatty acid, and select which sample they believe is different. The concentration of fatty acid used will range from very dilute to a maximum of 5%. The test is repeated over the range of concentrations until a participant is able to correctly identify the fatty acid or until the maximum concentration is reached.

    Measured at weekly intervals over 3 months

Secondary Outcomes (3)

  • DNA sequence of potential fatty acid receptors (e.g., CD36, GPR120, GPR48)

    This will be collected at the final visit of the study, approximate 2-3 months from participant enrollment depending on how frequently the participant is able to come to the lab

  • Amount of habitual dietary fat intake

    Baseline

  • Measurement of hunger

    This will be measured at every study visit (21 visits plus 1 screening visit) over the 2-3 months of the study

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals between 18 and 60 years of age from any ethnic background who are in good health and are available for the next three months will be eligible.

You may qualify if:

  • years of age
  • in good health
  • available for 3 months

You may not qualify if:

  • Participation in a different fat taste study in previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • Running CA, Mattes RD. Different oral sensitivities to and sensations of short-, medium-, and long-chain fatty acids in humans. Am J Physiol Gastrointest Liver Physiol. 2014 Aug 1;307(3):G381-9. doi: 10.1152/ajpgi.00181.2014. Epub 2014 Jun 12.

Biospecimen

Retention: SAMPLES WITH DNA

Saliva will be collected to obtain DNA for analysis of genes for fatty acid receptors and their potential correlation with sensitivity.

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

August 12, 2013

First Posted

November 27, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2015

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations