ObesityFATYPNCT02699567
CD36 and Human Fat Taste Perception
An observational study of Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of common human variants in in taste related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste perception. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be men and women, 21 to 50 yrs of age of all races and ethnic groups. The two groups (i.e. groups with different CD36 genetic variants) will be matched as closely as possible in age, sex, body mass index and race distributions. Subject population will consist of lean subjects (BMI >18-<25 kg/m2) and subjects with obesity (BMI >29.9 kg/m2).
Who may be able to join
- BMI >18-<25 kg/m2 or BMI>29.9 kg/m2.
- 21 to 50 years of age
Who cannot join
- Previous malabsorptive or restrictive gastrointestinal surgery
- Smoking
- Pregnancy or breastfeeding
- Diabetes
- Taking medication that might affect taste perception
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: CD36 Involvement on Fat Taste Perception and Fat Hedonic Value in Humans
The purpose of this study is to determine the effect of common human variants in in taste related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste perception.
Read the detailed description
At present, the general agreement is that humans perceive five taste qualities: sweet, sour, bitter, salty and umami (the savory, meaty taste of some amino acids). It is believed that these qualities evolved to help us find nutrients (e.g. sweets, umami signaled calories) and avoid potential harmful substances (e.g. bitter signalized poison). Despite the fact that some fats, which can only be obtained through the diet, are essential for life, fat is not considered a basic taste; and, the issue of how fats are precisely sensed is unresolved. However, increasing evidence suggests that, in addition to smell and texture, taste plays an important role in fat perception. Putative fat taste receptor classes have been identified in animal models. One such receptor is the glycoprotein CD36, previously documented to be involved in trafficking and storage of fat. CD36 was recently found in rodents' and humans' taste buds. In rodents, CD36 deletion blunts specifically fat recognition. Although CD36 variants are frequent in humans, its role in humans' fat taste perception and preferences remains incompletely understood and will be the focus of the current proposal. The main goal of this study is to determine the effect of a common human variant in the CD36 gene on fat taste perception by using standardized sensory evaluation techniques. In addition, we will examine whether common variants in taste related genes (other than CD36) are associated with individual differences in the perception of flavors of milkshakes prepared with different amounts of fats.
- Conditions
- Obesity
- Being tested
- No intervention
- Keywords
- taste perception, individual differences, fat, genetics
- Medical subject headings
- Obesity, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Lean AA | Subjects with a BMI<=25 kg/m2 and carriers of a CD36 gene variation associated with low CD36 expression levels Receives: Other: No intervention | |
| Obese AA | Subjects with a BMI>29.9 kg/m2 and carriers of a CD36 gene variation associated with low CD36 expression levels Receives: Other: No intervention | |
| Lean GG | Subjects with a BMI<=25 kg/m2 and carriers of a CD36 gene variation associated with high CD36 expression levels Receives: Other: No intervention | |
| Obese GG | Subjects with a BMI>29.9 kg/m2 and carriers of a CD36 gene variation associated with high CD36 expression levels Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores in the general labeled magnitude scale for fat flavor intensity
Measured: One to 12 weeks following screening
Scores in the hedonic general labeled magnitude scale for fat flavor hedonic value
Measured: One to 12 weeks following screening
Secondary outcomes (1)
Number of participants who are PROP taster as assessed by sip and spit testing procedure of water with increasing PROP concentrations.
Measured: One to 12 weeks following screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startNov 2011
- Primary completionApr 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Monell Chemical Senses Center
- Responsible party
- Principal investigator, Marta Yanina Pepino de Gruev, Washington University School of Medicine
- Investigators
- Marta Y Pepino de Gruev, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699567
- Sponsor's protocol ID
- 201011853
- Acronym
- FATYP
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD36 Involvement on Fat Taste Perception and Fat Hedonic Value in Humans
- ClinicalTrials.gov ID
- NCT02699567
- Acronym / sponsor ID
- FATYP / 201011853
- Conditions
- Obesity
- Keywords
- taste perception, individual differences, fat, genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Monell Chemical Senses Center
- Study start
- Nov 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of common human variants in in taste related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste perception.
Detailed description
At present, the general agreement is that humans perceive five taste qualities: sweet, sour, bitter, salty and umami (the savory, meaty taste of some amino acids). It is believed that these qualities evolved to help us find nutrients (e.g. sweets, umami signaled calories) and avoid potential harmful substances (e.g. bitter signalized poison). Despite the fact that some fats, which can only be obtained through the diet, are essential for life, fat is not considered a basic taste; and, the issue of how fats are precisely sensed is unresolved. However, increasing evidence suggests that, in addition to smell and texture, taste plays an important role in fat perception. Putative fat taste receptor classes have been identified in animal models. One such receptor is the glycoprotein CD36, previously documented to be involved in trafficking and storage of fat. CD36 was recently found in rodents' and humans' taste buds. In rodents, CD36 deletion blunts specifically fat recognition. Although CD36 variants are frequent in humans, its role in humans' fat taste perception and preferences remains incompletely understood and will be the focus of the current proposal. The main goal of this study is to determine the effect of a common human variant in the CD36 gene on fat taste perception by using standardized sensory evaluation techniques. In addition, we will examine whether common variants in taste related genes (other than CD36) are associated with individual differences in the perception of flavors of milkshakes prepared with different amounts of fats.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lean AA | – | Other: No interventionSubjects with a BMI<=25 kg/m2 and carriers of a CD36 gene variation associated with low CD36 expression levels |
| Obese AA | – | Other: No interventionSubjects with a BMI>29.9 kg/m2 and carriers of a CD36 gene variation associated with low CD36 expression levels |
| Lean GG | – | Other: No interventionSubjects with a BMI<=25 kg/m2 and carriers of a CD36 gene variation associated with high CD36 expression levels |
| Obese GG | – | Other: No interventionSubjects with a BMI>29.9 kg/m2 and carriers of a CD36 gene variation associated with high CD36 expression levels |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be men and women, 21 to 50 yrs of age of all races and ethnic groups. The two groups (i.e. groups with different CD36 genetic variants) will be matched as closely as possible in age, sex, body mass index and race distributions. Subject population will consist of lean subjects (BMI >18-<25 kg/m2) and subjects with obesity (BMI >29.9 kg/m2).
Key inclusion criteria (2 listed)
- BMI >18-<25 kg/m2 or BMI>29.9 kg/m2.
- 21 to 50 years of age
Key exclusion criteria (5 listed)
- Previous malabsorptive or restrictive gastrointestinal surgery
- Smoking
- Pregnancy or breastfeeding
- Diabetes
- Taking medication that might affect taste perception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Lean AA, Lean GG, Obese AA, Obese GG |
Primary outcome
Scores in the general labeled magnitude scale for fat flavor intensity
Time frame: One to 12 weeks following screening
Scores in the hedonic general labeled magnitude scale for fat flavor hedonic value
Time frame: One to 12 weeks following screening
1 secondary outcome
Number of participants who are PROP taster as assessed by sip and spit testing procedure of water with increasing PROP concentrations.
Time frame: One to 12 weeks following screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Y Pepino de Gruev, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores in the general labeled magnitude scale for fat flavor intensity (time frame: One to 12 weeks following screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.