Fat Perception in Humans (09-0873)

NCT ID: NCT01128400

Last Updated: 2018-07-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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%.

No interventions assigned to this group

rs1761667-GG genotype

subjects who are homozygous of CD36 genotype rs1761667-G allele.

No interventions assigned to this group

rs1761667-AG genotype

Heterozygous of CD36 gene rs1761667-A genotype.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Y Pepino de Gruev, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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09-0873

Identifier Type: -

Identifier Source: org_study_id

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