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OpenTrials
Completed

NCT Number: NCT01128400

Fat Perception in Humans (09-0873)

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Inhibition of Lipolysis in Oral Cavity and Fat Perception in Humans

Acronym: OT

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 21, 2010
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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