Repeated Food Exposure Via the Olfactory and Gustatory Systems
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| First Received Date ICMJE | July 24, 2012 | ||||||||
| Last Updated Date | July 25, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Amount of Salivation [ Time Frame: 12 trials (90 minutes) ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01651221 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Repeated Food Exposure Via the Olfactory and Gustatory Systems | ||||||||
| Official Title ICMJE | Repeated Food Exposure Via the Olfactory and Gustatory Systems | ||||||||
| Brief Summary | Increasing exposure to a single orosensory cue without ingestion of additional energy may promote an increased rate of habituation, more rapid satiation, and reduced intake. This exposure can occur via smell (olfactory) and taste (gustatory) systems.It is not clear if repeated exposure via the combined olfactory and gustatory systems increases the rate of habituation more so than repeated exposure through one of these systems. Thus, the purpose of this investigation is to examine the amount of salivation occurring in 12 trials of exposure to a food via the olfactory, gustatory, and combined olfactory and gustatory systems. The primary dependent variable will be the amount of salivation in the 12 trials. It is hypothesized that a more rapid decrease in salivation will occur across trials in the combined olfactory and gustatory exposure as compared to the other two conditions, indicating a more rapid rate of habituation. |
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| Detailed Description | Approximately two of every three adults in the U.S. are overweight or obese. The high prevalence of overweight/obesity negatively affects the health of the population, as obese individuals are at increased risk for developing several chronic diseases. Successful control of body weight depends on effectively regulating eating. Satiation, the process by which an eating bout ends, assists with eating regulation, and factors that quicken the onset of satiation may aid with decreasing intake. One factor believed to influence satiation is the rate of decrease in consummatory response (habituation) to repeated presentations of food orosensory cues. Habituation is a basic form of learning, in which behavioral and physiological responses decrease in response to repeated presentations of a stimulus, with the decrease in response unrelated to sensory adaptation/fatigue or motor fatigue. In one condition, participants will smell lemon and lime across 12 trials (olfactory exposure), in another condition participants will taste the juices across 12 trials (gustatory exposure), and in the last condition participants will smell and taste the juices across 12 trials (olfactory + gustatory exposure). The primary dependent variable will be the amount of salivation in the 12 trials. It is hypothesized that a more rapid decrease in salivation will occur across trials in the combined olfactory and gustatory exposure as compared to the other two conditions, indicating a more rapid rate of habituation |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Habituation | ||||||||
| Intervention ICMJE | Other: Habituation
Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 30 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01651221 | ||||||||
| Other Study ID Numbers ICMJE | 8879B | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Tennessee | ||||||||
| Study Sponsor ICMJE | University of Tennessee | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Tennessee | ||||||||
| Verification Date | July 2012 | ||||||||
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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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