Trial Outcomes & Findings for Fat Perception in Humans (09-0873) (NCT NCT01128400)
NCT ID: NCT01128400
Last Updated: 2018-07-17
Results Overview
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.
COMPLETED
40 participants
Ranges from 5 days after screening to several weeks, pending availablity of participant.
2018-07-17
Participant Flow
May 2010- August 2011 recruited by local posters and media advertising via the Washington University Research Participant Registry.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
23
|
|
Overall Study
COMPLETED
|
6
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
16
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Screening failure
|
1
|
0
|
0
|
|
Overall Study
were not invited to participate on taste
|
0
|
0
|
15
|
|
Overall Study
Excluded due to sinus problems
|
0
|
1
|
0
|
Baseline Characteristics
Fat Perception in Humans (09-0873)
Baseline characteristics by cohort
| Measure |
rs1761667- AA Genotype
n=6 Participants
Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
|
rs1761667-GG Genotype
n=8 Participants
Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
|
rs1761667-AG Genotype
n=7 Participants
Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 14.0 • n=99 Participants
|
39.1 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
39.6 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
39.1 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
rs1761667- AA Genotype
n=6 Participants
Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
|
rs1761667-GG Genotype
n=8 Participants
Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
|
rs1761667-AG Genotype
n=7 Participants
Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
|
|---|---|---|---|
|
Oleic Acid Detection Level
|
-0.3 log10 (%W/V OLEIC ACID)
Standard Error 0.3
|
-1.2 log10 (%W/V OLEIC ACID)
Standard Error 0.2
|
-1.0 log10 (%W/V OLEIC ACID)
Standard Error 0.3
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
rs1761667- AA Genotype
n=6 Participants
Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
|
rs1761667-GG Genotype
n=8 Participants
Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
|
rs1761667-AG Genotype
n=7 Participants
Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
|
|---|---|---|---|
|
Triolein Detection
|
0.55 log10 (%W/V TRIOLEIN)
Standard Error 0.25
|
-0.33 log10 (%W/V TRIOLEIN)
Standard Error 0.22
|
-0.04 log10 (%W/V TRIOLEIN)
Standard Error 0.23
|
Adverse Events
rs1761667- AA Genotype
rs1761667-GG Genotype
rs1761667-AG Genotype
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
M. Yanina Pepino
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place