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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 17, 2001 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | August 2001 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00022997 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Taste Deficits | ||||||||
| Official Title ICMJE | Studies of Deficits in the Sense of Taste | ||||||||
| Brief Summary | This study will explore the genetics of taste and taste deficits. The sense of taste plays a crucial role in food choices, allowing people to identify beneficial foods (those with high caloric value, which are typically sweet) and foods likely to be toxic (usually bitter substances). The loss of sense of taste in older people plays a role in decreased appetite and poor nutrition. Taste deficits may adversely affect people in ways that are not well understood. This study will examine why some people (about one-fourth of all people in the United States) cannot taste a substance called phenylthiocarbamide (PTC). The inability to taste PTC is due to inherited factors that are not yet clear. Individuals age 18 and older who can taste PTC and individuals who cannot taste PTC may be eligible for this study. Participants will taste a number of liquid solutions until they find one with a clear taste. Then they will taste another group of solutions and decide which ones have that taste and which have no taste. Finally, they will taste a third group of solutions until they find one with a different taste. About 2 tablespoons of blood will be drawn from participants for genetic tests related to the sense of taste. |
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| Detailed Description | The primary goal of this study is to identify the underlying cause of deficits in the ability to taste different commonly consumed substances, including the bitter compound phenylthiocarbamide (PTC) as a model. Individuals will be tested to identify those who can and cannot taste PTC, as well as for their ability to taste a variety of sweet, sour, salty, and savory substances. Individuals will have 20 cc of blood drawn to obtain DNA. These DNA samples will then be analyzed for variation in genes whose products are known to be involved in taste perception pathways. Information about individuals' DNA sequence variation will then be correlated with their taste phenotype to identify the specific genetic variation that causes phenotypic variation, providing molecular structure-function information in taste sensory pathways. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 400 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
This study includes medically normal individuals age 18 and older. This study includes both males and females, and includes members of all racial and ethnic groups. This study includes both individuals with a normal sense of taste, those unable to taste PTC, and those with varying degrees of taste sensitivity for other taste substances. EXCLUSION CRITERIA: Individuals excluded will be those under age 18, those who are cognitively impaired, those with a physical impairment in swallowing, those who have general impairments in the sense of taste, those currently using psychoactive medication, prisoners, or other at-risk populations. |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00022997 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 010230, 01-DC-0230 | ||||||||
| Study Sponsor ICMJE | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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