NCT01651221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3.4 years

First QC Date

July 24, 2012

Last Update Submit

April 3, 2018

Conditions

Keywords

gustatory responseolfactory response

Outcome Measures

Primary Outcomes (1)

  • Amount of Salivation

    12 trials (90 minutes)

Study Arms (3)

Olfactory

EXPERIMENTAL

Habituation of olfactory response

Other: Habituation

gustatory

EXPERIMENTAL

Habituation of gustatory response.

Other: Habituation

olfactory and gustatory

EXPERIMENTAL

Habituation of olfactory and gustatory response

Other: Habituation

Interventions

Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study.

Olfactorygustatoryolfactory and gustatory

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Lab, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Habituation, Psychophysiologic

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hollie A Raynor, PhD RD LDN

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations