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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Oleic Acid Detection Level | 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marta Y Pepino de Gruev, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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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.
May 2010- August 2011 recruited by local posters and media advertising via the Washington University Research Participant Registry.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%. |
| FG001 | rs1761667-GG Genotype | subjects who are homozygous of CD36 genotype rs1761667-G allele. |
| FG002 | rs1761667-AG Genotype | Heterozygous of CD36 gene rs1761667-A genotype. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | rs1761667- AA Genotype | Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level |
| BG001 | rs1761667-GG Genotype |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oleic Acid Detection Level | 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. | Posted | Mean | Standard Error | log10 (%W/V OLEIC ACID) | Ranges from 5 days after screening to several weeks, pending availablity of participant. |
|
2 year
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rs1761667- AA Genotype | Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Yanina Pepino | Washington University School of Medicine | 3143628113 | ypepino@dom.wustl.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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whole blood will be collected and frozen
| were not invited to participate on taste |
|
| Excluded due to sinus problems |
|
Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
| BG002 | rs1761667-AG Genotype | Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | rs1761667-AG Genotype | Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype. |
|
|
|
| Primary | Triolein Detection | 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. | Posted | Mean | Standard Error | log10 (%W/V TRIOLEIN) | Ranges from 5 days after screening to several weeks, pending availablity of participant. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | rs1761667-GG Genotype | Obese subjects who are homozygous of CD36 genotype rs1761667-G allele. | 0 | 0 | 0 | 0 |
| EG002 | rs1761667-AG Genotype | Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype. | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |