- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198911
The Effects of Chewing Gum on a Computer Task and Liking Ratings of Ice Cream
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately two-thirds of U.S. adults are overweight or obese, thus placing obesity first as a public health concern in the U.S. Not only is obesity detrimental at the individual level, by increasing risk for chronic disease and premature mortality, but it also presents problems at the economical level by increasing medical costs.
At the heart of weight management is the ability to appropriately regulate energy intake. A key factor in regulation of consumption is satiation, the process by which an eating bout ends. Quicker onset of satiation may result in decreased consumption, which is important in achieving an adequate energy balance. Negative energy balance, in which energy intake is less than energy expenditure, is required for weight loss; however, there are challenges with increased hunger and decreased satiation as energy intake is decreased.
One of the factors believed to influence satiation is the ability to increase the rate of habituation occurring during an eating bout. Habituation is a basic form of learning that can be measured by the rate of decrease in consummatory response to repeated presentations of food orosensory cues. Following this decreased response rate to a particular food, presentation of new orosensory cues may result in dishabituation to both the previously habituated food as well as the new orosensory cue, thus causing an increase in consummatory response. Dishabituation during an eating bout, i.e. exposure to a variety of orosensory cues, may be related to recovery of appetite and decreased satiation, leading the calorie-replete individual to overconsume. Alternatively, with repeated presentations of the same orosensory cue, one becomes accustomed to the taste faster, giving rise to habituation, which should increase satiation. A more rapid rate of habituation would mean that less energy is consumed within an eating bout. Research indicates increased weight status in relation to slower habituation rates as well as an inverse relationship between the extent of orosensory variety and habituation rates. Additionally, research shows a positive association between amount of orosensory cues and amount consumed within an eating bout.
One way to provide a single orosensory cue and initiate enhanced habituation with a minimal amount of additional energy intake is by chewing sugar-free, flavored gum. If matched to the flavor of the food about to be consumed, chewing gum prior to an eating bout may increase the rate of habituation, consequently reducing consumption.
Therefore, the purpose of this proof-of-concept study is to examine if chewing gum before an eating bout will increase the rate of habituation and subsequently reduce energy intake within the eating bout. The outcomes of this study may be useful in the health setting for creating prescriptions for weight-loss, weight maintenance, and weight-gain prevention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996
- Healthy Eating and Activity Labroatory, University of Tennessee, Knoxville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age between 18 and 40 years
- of normal weight (body mass index [BMI] between 18.5 and 24.9 kg/m2)
- unrestrained eater (scoring less than/equal to 12 on the restraint scale of the Three Factor Eating Questionnaire [TFEQ15])
- non-smoker (not having smoked or used tobacco products for a year or more)
- like and are willing to eat (greater than/equal to 50mm on a 100mm visual analogue scale [VAS]) MCC ice cream
Exclusion Criteria:
- have any health condition that requires a specific dietary prescription (i.e., diabetes)
- are unable to chew the gum for the time required in the investigation; 3) do not like the flavors of gum used in the investigation
- are allergic to any ingredients in the foods used in the investigation
- are lactose-intolerant
- plan to make any changes in dietary intake or physical activity over the course of the study
- score >20 on the Eating Attitudes Test (EAT8)
- score >16 on the Binge Eating Scale (BES10)
- are not able to stay within the metropolitan area within the time frame of the investigation
- are pregnant, lactating, or plan to become pregnant during the investigation
- are taking any type of medication that influences appetite.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Order 1
Gum chewing order for sessions, 1-3 respectively: NO GUM, MCC, C
|
For the NO GUM condition, participants will not chew gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
For the MCC gum condition, participants will chew MCC gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
For the C gum condition, participants will chew Cinnamon gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
|
|
Active Comparator: Order 2
Gum chewing order for ice-cream sessions, 1-3 respectively: MCC, C, NO GUM
|
For the NO GUM condition, participants will not chew gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
For the MCC gum condition, participants will chew MCC gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
For the C gum condition, participants will chew Cinnamon gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
|
|
Active Comparator: Order 3
Gum chewing order for ice-cream sessions, 1-3 respectively: C, NO GUM, MCC
|
For the NO GUM condition, participants will not chew gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
For the MCC gum condition, participants will chew MCC gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
For the C gum condition, participants will chew Cinnamon gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grams of ice cream eaten
Time Frame: 3 trials (60 minutes)
|
Amount of ice cream consumed will be measured using the following formula: amount of ice cream before consumption (first weight) - amount of ice cream following consumption (second weight).
Grams of ice cream consumed will be determined following each 60 minute session (1, 2, and 3).
|
3 trials (60 minutes)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- 9212-B
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.
Clinical Trials on Habituation
-
The University of Tennessee, KnoxvilleCompleted
-
Medical Corps, Israel Defense ForceCompletedMotion Sickness | Seasickness | Habituation | Vestibular Time Constant
-
University Hospital, BrestRecruitingHabituation, Psychophysiological | Preterm, InfantFrance
-
Ruhr University of BochumCompleted
-
The University of Tennessee, KnoxvilleCompletedHealthy | Food Preferences | Addictive Behavior | Food Habits | HabituationUnited States
-
Oral Health Center of Expertise Rogaland, NorwayUniversity of Oslo; Oral Health Centre of Expertise in Western Norway; The public... and other collaboratorsRecruitingAutism Spectrum Disorder | Habituation | Oral Health TrainingNorway
-
State University of New York at BuffaloNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedPediatric Obesity | HabituationUnited States
-
Kaiser PermanenteCompletedDepressive Disorder | Pain | Drug Abuse | Drug Addiction | Drug Dependence | Drug Use Disorders | Drug Habituation
Clinical Trials on NO GUM
-
Clinical Nutrition Research Center, Illinois Institute...Wm. Wrigley Jr. CompanyCompleted
-
Purdue UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedThe Null Hypothesis is That Food Rheology Will Have no Effect on These Indices | The Alternate Hypothesis is That Increased Mechanical Stimulation Will Result in Stronger Satiation/Satiety and Reduced Energy Intake | It is Hypothesized That the Effects of Mastication Will be Less Evident...United States
-
University of TorontoNot yet recruitingDental Caries | Dental Plaque | Periodontal Disease
-
Allina Health SystemCompletedColon ResectionUnited States
-
University of PlymouthHALEONRecruiting
-
University of WashingtonRecruitingNeurodevelopmental Disorders | PrematurityMalawi
-
NexiraAnalyze & RealizeCompletedHealthy | OverweightGermany
-
Ege UniversityCompleted
-
Universidad Católica de CuencaCompleted
-
Muttalip AyarCompletedAthletic PerformanceTurkey (Türkiye)