Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

August 15, 2016 updated by: University of Pennsylvania

Use of Chewing Gum to Facilitate Appetite Control and Weight Loss in Overweight Individuals Treated by Lifestyle Modification

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss.
Behavioral: Lifestyle modification
16 weekly followed by 8 monthly group behavioral weight loss sessions.
Other Names:
  • Behavioral weight loss
  • Behavior modification
Experimental: 2
Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.
Behavioral: Lifestyle modification plus gum
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.
Other Names:
  • Behavioral weight loss
  • Behavior modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: Week 16 and 52
Week 16 and 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Appetite control
Time Frame: Weeks 4, 8, 12, 16 and 52
Weeks 4, 8, 12, 16 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

  • Principal Investigator: Thomas A Wadden, Ph.D, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804361

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.

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