Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 69 for:    ORLISTAT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01128400
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : July 3, 2014
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date May 20, 2010
First Posted Date May 21, 2010
Results First Submitted Date June 2, 2014
Results First Posted Date July 3, 2014
Last Update Posted Date July 17, 2018
Study Start Date May 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: May 20, 2010)
  • Oleic Acid Detection Level [ Time Frame: baseline ]
    We will measure oleic acid detection levels as a marker of subjects' ability to detect free fatty acids.
  • Triolein Detection [ Time Frame: baseline ]
    We will measure triolein detection levels as a marker of subjects' ability to detect triglyceride.
Change History Complete list of historical versions of study NCT01128400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 20, 2010)
  • Fungiform papillae density [ Time Frame: baseline ]
    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 ]
    genetic variations for the gene CD36.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fat Perception in Humans (09-0873)
Official Title Inhibition of Lipolysis in Oral Cavity and Fat Perception in Humans
Brief Summary

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
  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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood will be collected and frozen
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.
Condition Obesity
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 2, 2014)
40
Original Estimated Enrollment
 (submitted: May 20, 2010)
30
Actual Study Completion Date June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01128400
Other Study ID Numbers 09-0873
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators GlaxoSmithKline
Investigators
Principal Investigator: Marta Y Pepino de Gruev, Ph.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date June 2018