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

Inhibition of Lipolysis in Oral Cavity and Fat Perception in Humans

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 40 obese subjects 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oleic Acid Detection Level
Time Frame: Ranges from 5 days after screening to several weeks, pending availablity of participant.
We will measure oleic acid detection levels as a marker of subjects' ability to detect free fatty acids. Oleic acid taste detection thresholds were separately assessed using a three-alternative forced-choice (i.e. 3-AFC) ascending concentration.
Ranges from 5 days after screening to several weeks, pending availablity of participant.
Triolein Detection
Time Frame: Ranges from 5 days after screening to several weeks, pending availablity of participant.
We will measure triolein detection levels as a marker of subjects' ability to detect triglyceride. Triolein taste detection thresholds were separately assessed using a three-alternative forced-choice (i.e. 3-AFC) ascending concentration.
Ranges from 5 days after screening to several weeks, pending availablity of participant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 09-0873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

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