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Fat Perception in Humans (09-0873) (OT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Marta Yanina Pepino de Gruev, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01128400
First received: May 20, 2010
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

There are many substances naturally present in the mouth that may help us taste fat in food. Two of these substances (lipases and CD36) will be examined in this study.

The presence of fat in food increases food tastiness, therefore people often over-eat high-fat foods and gain weight. The purpose of this study is to determine if blocking lipases and some genetic variations in the CD36 gene will make fatty food less tasty so that people eat less. Our hypothesis is that Orlistat and a particular gene will increase one's ability to detect fat.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Inhibition of Lipolysis in Oral Cavity and Fat Perception in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • oleic acid detection level [ Time Frame: baseline ] [ Designated as safety issue: No ]
    We will measure oleic acid detection levels as a marker of subjects' ability to detect free fatty acids.

  • triolein detection [ Time Frame: baseline ] [ Designated as safety issue: No ]
    We will measure triolein detection levels as a marker of subjects' ability to detect triglyceride.


Secondary Outcome Measures:
  • Fungiform papillae density [ Time Frame: baseline ] [ Designated as safety issue: No ]
    We will take a picture of subjects' tongues and count the number of papillae (i.e. mushroom-shaped elevated structures in the tongue containing the taste buds).

  • CD36 genotype [ Time Frame: baseline ] [ Designated as safety issue: No ]
    genetic variations for the gene CD36.


Biospecimen Retention:   Samples With DNA

whole blood will be collected and frozen


Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
rs1761667- AA genotype
subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level and has a minor allele frequency of 38-48%.
rs1761667-GG genotype
subjects who are homozygous of CD36 genotype rs1761667-G allele.
rs1761667-AG genotype
Heterozygous of CD36 gene rs1761667-A genotype.

Detailed Description:

  1. Determine the effect of lipolysis inhibition in oral cavity on orosensory detection of fat in humans.

    Hypothesis: Orally applied Orlistat will increase detection thresholds of TAGs but not FFA in humans.

    To test this hypothesis we will measure triolein (a TAG) and oleic acid (a FFA) taste detection thresholds with a three-alternative forced-choice (3-AFC) ascending concentration method under two conditions (Orlistat day vs. Control day). To control for olfactory input, subjects will be assessed wearing noseclips.

  2. Determine the effect of CD36 variants on fat taste perception in humans. Hypothesis: SNPs that associate with reduced CD36 expression will be associated with higher FFA and TAG detection thresholds

To test this hypothesis we will measure triolein and oleic acid taste detection thresholds in subjects who carry of the common CD36 e-SNP rs1761667 (i.e. a SNP that significantly reduces CD36 level and has a minor allele frequency of 38-48%). We expect subjects who are at least heterozygous for the expression reducing allele to have higher triolein and oleic acid taste detection thresholds compared to non-carrier subjects.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A total of 30 obese subjects with normal sucrose taste threshold will participate in this study. Subjects will be men and women and will include all races and ethnic groups. The two groups (carriers and non-will be matched as closely as possible in age, sex, body mass index (kg/m2) and race distributions.

Criteria

Inclusion Criteria:

  • Body Mass Index greater than 30 kg/m2

Exclusion Criteria:

  • smokers or who quit smoking less than six months ago
  • pregnancy
  • breastfeeding
  • diabetes
  • taking medications that might affect taste perception
  • previous malabsorptive or restrictive intestinal surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128400

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
GlaxoSmithKline
Investigators
Principal Investigator: Marta Y Pepino de Gruev, Ph.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Marta Yanina Pepino de Gruev, Research Assistant Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01128400     History of Changes
Other Study ID Numbers: 09-0873
Study First Received: May 20, 2010
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
obesity
orlistat
taste perception

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013