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Trial record 50 of 69 for:    ORLISTAT

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

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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

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Cross-Sectional
Condition Obesity
Enrollment 40
Recruitment Details May 2010- August 2011 recruited by local posters and media advertising via the Washington University Research Participant Registry.
Pre-assignment Details 40 subjects signed consent form and were screened for rs1761667 genotype and three groups (i.e., AA, AG and GG) matched in age and BMI were invited to participate on the taste test.
Arm/Group Title rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype
Hide Arm/Group Description 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%. subjects who are homozygous of CD36 genotype rs1761667-G allele. Heterozygous of CD36 gene rs1761667-A genotype.
Period Title: Overall Study
Started 8 9 23
Completed 6 8 7
Not Completed 2 1 16
Reason Not Completed
Lost to Follow-up             1             0             1
Screening failure             1             0             0
were not invited to participate on taste             0             0             15
Excluded due to sinus problems             0             1             0
Arm/Group Title rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype Total
Hide Arm/Group Description Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level Obese subjects who are homozygous of CD36 genotype rs1761667-G allele. Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype. Total of all reporting groups
Overall Number of Baseline Participants 6 8 7 21
Hide Baseline Analysis Population Description
Three groups of obese subjects (body mass index [BMI] >30 kg/m2) participated in this study. The three groups were matched on age, because there is a generic decline in taste perception with age.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 7 participants 21 participants
38.7  (14.0) 39.1  (7.0) 39.6  (6.4) 39.1  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 7 participants 21 participants
Female
6
 100.0%
6
  75.0%
6
  85.7%
18
  85.7%
Male
0
   0.0%
2
  25.0%
1
  14.3%
3
  14.3%
1.Primary Outcome
Title Oleic Acid Detection Level
Hide Description 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.
Time Frame Ranges from 5 days after screening to several weeks, pending availablity of participant.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype
Hide Arm/Group Description:
Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
Overall Number of Participants Analyzed 6 8 7
Mean (Standard Error)
Unit of Measure: log10 (%W/V OLEIC ACID)
-0.3  (0.3) -1.2  (0.2) -1.0  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rs1761667- AA Genotype, rs1761667-GG Genotype, rs1761667-AG Genotype
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Triolein Detection
Hide Description 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.
Time Frame Ranges from 5 days after screening to several weeks, pending availablity of participant.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype
Hide Arm/Group Description:
Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
Overall Number of Participants Analyzed 6 8 7
Mean (Standard Error)
Unit of Measure: log10 (%W/V TRIOLEIN)
0.55  (0.25) -0.33  (0.22) -0.04  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rs1761667- AA Genotype, rs1761667-GG Genotype, rs1761667-AG Genotype
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 2 year
Adverse Event Reporting Description For the taste testing study, all taste testing stimuli were prepared in a metabolic kitchen using proper food safety guidelinse and none of the stimuli that were tasted were swallowed (i.e. we used a sip and spit technique). Therefore, we did not anticipate and did not planned on collecting/assessing adverse events.
 
Arm/Group Title rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype
Hide Arm/Group Description Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level Obese subjects who are homozygous of CD36 genotype rs1761667-G allele. Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
All-Cause Mortality
rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rs1761667- AA Genotype rs1761667-GG Genotype rs1761667-AG Genotype
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M. Yanina Pepino
Organization: Washington University School of Medicine
Phone: 3143628113
EMail: ypepino@dom.wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01128400     History of Changes
Other Study ID Numbers: 09-0873
First Submitted: May 20, 2010
First Posted: May 21, 2010
Results First Submitted: June 2, 2014
Results First Posted: July 3, 2014
Last Update Posted: July 17, 2018