NCT02699567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
Last Updated

March 4, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

February 25, 2016

Last Update Submit

February 29, 2016

Conditions

Keywords

taste perceptionindividual differencesfatgenetics

Outcome Measures

Primary Outcomes (2)

  • Scores in the general labeled magnitude scale for fat flavor intensity

    One to 12 weeks following screening

  • Scores in the hedonic general labeled magnitude scale for fat flavor hedonic value

    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.

    One to 12 weeks following screening

Study Arms (4)

Lean AA

Subjects with a BMI\<=25 kg/m2 and carriers of a CD36 gene variation associated with low CD36 expression levels

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

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

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

Other: No intervention

Interventions

Lean AALean GGObese AAObese GG

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • Previous malabsorptive or restrictive gastrointestinal surgery
  • Smoking
  • Pregnancy or breastfeeding
  • Diabetes
  • Taking medication that might affect taste perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Extracted genomic DNA

MeSH Terms

Conditions

ObesityPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marta Y Pepino de Gruev, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 4, 2016

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

July 1, 2014

Last Updated

March 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations