Fat Perception in Humans (09-0873)

NCT01128400 | Completed Results

• 1 other identifier: 09-0873
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

obesity; orlistat; taste perception

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

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.

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Body Mass Index greater than 30 kg/m²

You may not qualify if:

• smokers or who quit smoking less than six months ago
• pregnancy
• breastfeeding
• diabetes
• taking medications that might affect taste perception
• previous malabsorptive or restrictive intestinal surgery

Sponsors & Collaborators

• Washington University School of Medicine: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood will be collected and frozen

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: M. Yanina Pepino
• Organization: Washington University School of Medicine

ypepino@dom.wustl.edu

3143628113

Study Officials

• Marta Y Pepino de Gruev, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 17, 2018
• Results First Posted: July 3, 2014

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)