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CD36 and Human Fat Taste Perception (FATYP)

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ClinicalTrials.gov Identifier: NCT02699567
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Collaborator:
Monell Chemical Senses Center
Information provided by (Responsible Party):
Marta Yanina Pepino de Gruev, Washington University School of Medicine

Tracking Information
First Submitted Date February 25, 2016
First Posted Date March 4, 2016
Last Update Posted Date March 4, 2016
Study Start Date November 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 29, 2016)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 29, 2016)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CD36 and Human Fat Taste Perception
Official Title CD36 Involvement on Fat Taste Perception and Fat Hedonic Value in Humans
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Extracted genomic DNA
Sampling Method Non-Probability Sample
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).
Condition Obesity
Intervention Other: No intervention
Study Groups/Cohorts
  • Lean AA
    Subjects with a BMI<=25 kg/m2 and carriers of a CD36 gene variation associated with low CD36 expression levels
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: Other: No intervention
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: February 29, 2016)
97
Original Actual Enrollment Same as current
Actual Study Completion Date July 2014
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • BMI >18-<25 kg/m2 or BMI>29.9 kg/m2.
  • 21 to 50 years of age

Exclusion Criteria:

  • Previous malabsorptive or restrictive gastrointestinal surgery
  • Smoking
  • Pregnancy or breastfeeding
  • Diabetes
  • Taking medication that might affect taste perception
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 NCT02699567
Other Study ID Numbers 201011853
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marta Yanina Pepino de Gruev, Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Monell Chemical Senses Center
Investigators
Principal Investigator: Marta Y Pepino de Gruev, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date February 2016