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Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle modification
Lifestyle modification plus gum
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 21-75 years of age
  • Body Mass Index of 25-45 inclusive

Exclusion Criteria:

  • major medical psychiatric conditions
  • medications know to effect weight
  • full or partial dentures
  • 18 or fewer teeth
  • regular gum chewing (≥ 2 pieces/day)
  • use of any tobacco product
  • sensitivity to the following ingredients (mint, magnolia bark, eggs, or English Muffins)
  • history of PKU
  • sensitivity or allergy to aspartame
  • current/history of alcohol abuse or addiction (within 5 year)
  • recreational drug use
  • recent significant weight change (+/- 5% in previous 6 months)
  • currently pregnant or nursing and willingness not to get pregnant during course of study
  • participation in any other research studies
  • proximity to clinic (within one hour)
  • access to reliable transportation

Sites / Locations

  • University of Pennsylvania School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss.

Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Appetite control

Full Information

First Posted
March 27, 2009
Last Updated
August 15, 2016
Sponsor
University of Pennsylvania
Collaborators
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT00871676
Brief Title
Use of Chewing Gum to Facilitate Appetite Control and Weight Loss
Official Title
Use of Chewing Gum to Facilitate Appetite Control and Weight Loss in Overweight Individuals Treated by Lifestyle Modification
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania
Collaborators
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle modification to facilitate appetite control and weight loss in overweight and obese individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss.
Arm Title
2
Arm Type
Experimental
Arm Description
Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Other Intervention Name(s)
Behavior modification, Behavioral weight loss
Intervention Description
16 weekly followed by 8 monthly group behavioral weight loss sessions.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification plus gum
Other Intervention Name(s)
Behavior modification, Behavioral weight loss
Intervention Description
16 weekly followed by 8 monthly group behavioral weight loss sessions. Subjects were also given gum along with instructions for times and occasions to chew with the aim of facilitating weight loss and appetite control.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
Week 16 and 52
Secondary Outcome Measure Information:
Title
Appetite control
Time Frame
Weeks 4, 8, 12, 16 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 21-75 years of age Body Mass Index of 25-45 inclusive Exclusion Criteria: major medical psychiatric conditions medications know to effect weight full or partial dentures 18 or fewer teeth regular gum chewing (≥ 2 pieces/day) use of any tobacco product sensitivity to the following ingredients (mint, magnolia bark, eggs, or English Muffins) history of PKU sensitivity or allergy to aspartame current/history of alcohol abuse or addiction (within 5 year) recreational drug use recent significant weight change (+/- 5% in previous 6 months) currently pregnant or nursing and willingness not to get pregnant during course of study participation in any other research studies proximity to clinic (within one hour) access to reliable transportation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Wadden, Ph.D
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

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