NCT02198911

Brief Summary

The purpose of this 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

5.6 years

First QC Date

March 25, 2014

Last Update Submit

April 1, 2025

Conditions

Habituation

Keywords

HabituationOrosensory cuesSatiation

Outcome Measures

Primary Outcomes (1)

  • Grams of ice cream eaten

    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)

Study Arms (3)

Order 1

ACTIVE COMPARATOR

Gum chewing order for sessions, 1-3 respectively: NO GUM, MCC, C

Other: NO GUMOther: MCC (Mint Chocolate Chip gum)Other: C (Cinnamon gum)

Order 2

ACTIVE COMPARATOR

Gum chewing order for ice-cream sessions, 1-3 respectively: MCC, C, NO GUM

Other: NO GUMOther: MCC (Mint Chocolate Chip gum)Other: C (Cinnamon gum)

Order 3

ACTIVE COMPARATOR

Gum chewing order for ice-cream sessions, 1-3 respectively: C, NO GUM, MCC

Other: NO GUMOther: MCC (Mint Chocolate Chip gum)Other: C (Cinnamon gum)

Interventions

NO GUMOTHER

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.

Order 1Order 2Order 3
MCC (Mint Chocolate Chip gum)OTHER

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.

Order 1Order 2Order 3
C (Cinnamon gum)OTHER

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.

Order 1Order 2Order 3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Labroatory, University of Tennessee, Knoxville

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

March 25, 2014

First Posted

July 24, 2014

Study Start

June 1, 2013

Primary Completion

December 31, 2018

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Locations

US(1)