HabituationNCT01651221
Repeated Food Exposure Via the Olfactory and Gustatory Systems
A study testing Habituation in people with Habituation, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Habituation
- What is being tested?
- Habituation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Lab, University of Tennessee
Knoxville, Tennessee, 37996
About this study
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.
Read the 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
- Conditions
- Habituation
- Being tested
- Habituation
- Keywords
- gustatory response, olfactory response
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HabituationOther
Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study.
| Study group | Role | What they receive |
|---|---|---|
| Olfactory | Experimental | Habituation of olfactory response Receives: Other: Habituation |
| gustatory | Experimental | Habituation of gustatory response. Receives: Other: Habituation |
| olfactory and gustatory | Experimental | Habituation of olfactory and gustatory response Receives: Other: Habituation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Salivation
Measured: 12 trials (90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HabituationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD RD LDN, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651221
- Sponsor's protocol ID
- 8879B
- Status last verified
- Apr 2018
- First submitted
- 24 Jul 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Food Exposure Via the Olfactory and Gustatory Systems
- ClinicalTrials.gov ID
- NCT01651221
- Acronym / sponsor ID
- 8879B
- Conditions
- Habituation
- Keywords
- gustatory response, olfactory response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olfactory | Experimental | Other: HabituationHabituation of olfactory response |
| gustatory | Experimental | Other: HabituationHabituation of gustatory response. |
| olfactory and gustatory | Experimental | Other: HabituationHabituation of olfactory and gustatory response |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HabituationHabituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study. | Other | Olfactory, gustatory, olfactory and gustatory |
Primary outcome
Amount of Salivation
Time frame: 12 trials (90 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie A Raynor, PhD RD LDN principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habituation in people with Habituation, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Salivation (time frame: 12 trials (90 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.