NCT01043471

Brief Summary

The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

First QC Date

December 15, 2009

Last Update Submit

October 6, 2015

Conditions

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in body composition

    Baseline and end of study (6 weeks)

Study Arms (2)

Chewing gum

EXPERIMENTAL
Other: Chewing gum

Water

PLACEBO COMPARATOR
Other: Water

Interventions

Subjects were instructed to chew gum at least 6 times a day in an effort to reduce snacking.

Chewing gum
WaterOTHER

Subjects were instructed to drink 8 oz of water at least 6 times a day in an effort to reduce snacking.

Water

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 27-37, between the ages of 18 and 38

You may not qualify if:

  • History of chronic disease (e.g. liver, kidney, or heart disease, or diabetes)
  • Medications that affect energy expenditure, appetite, or body composition (e.g. antidepressants, beta blockers, antipsychotic, or weight loss medications)
  • A history of irregular menstrual cycles in women (indication of onset of menopause or other metabolic disturbances such as polycystic ovary syndrome)
  • A history of phenylketonuria (PKU)
  • Symptoms of depression
  • A history of eating disorders
  • Concurrent participation in a weight loss program
  • Cigarette smoking or other tobacco use
  • Jaw problems such as temporomandibular joint disorder (TMJ)
  • Allergies to any of the common components in gum (sweeteners, mint flavors, etc)
  • Heavy gum chewing prior to study ( \> 3 times per week)
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Chewing GumWater

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Leah D Whigham, PhD

    Board of Regents of the University of Wisconsin System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2009

First Posted

January 6, 2010

Study Start

September 1, 2008

Study Completion

January 1, 2011

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations