Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871676
• Other study ID #: 804361
• Status: Completed
• Phase: N/A
• First received: March 27, 2009
• Last updated: August 15, 2016
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: March 2009
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Lifestyle modification
16 weekly followed by 8 monthly group behavioral weight loss sessions.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		Week 16 and 52	No
Secondary	Appetite control		Weeks 4, 8, 12, 16 and 52	No