- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651221
Repeated Food Exposure Via the Olfactory and Gustatory Systems
Study Overview
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Knoxville, Tennessee, United States, 37996
- Healthy Eating and Activity Lab, University of Tennessee
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Dietary restraint scores of less than or equal to 12 on the Three Factor -
- Eating Questionnaire-Cognitive Restraint scale.
- Have a body mass index (BMI) between 18.5 and 24.9.
Exclusion Criteria:
- Are taking medications or having an illness which might influence salivation, smell, and taste (i.e. upper respiratory illness, methylphenidate, atropine, Benadryl, Elavil, etc)
- Are currently dieting
- Are a binge eater
- Do not at least moderately like lemon or lime flavor scoring < 50 on a 100 mm visual analogue scale
- Are a regular smoker
- Have any dietary restrictions that will inhibit participation including food allergies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Olfactory
Habituation of olfactory response
|
Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study.
|
|
Experimental: gustatory
Habituation of gustatory response.
|
Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study.
|
|
Experimental: olfactory and gustatory
Habituation of olfactory and gustatory response
|
Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Amount of Salivation
Time Frame: 12 trials (90 minutes)
|
12 trials (90 minutes)
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Collaborators and Investigators
Investigators
- Principal Investigator: Hollie A Raynor, PhD RD LDN, University of Tennessee
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 8879B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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