- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043471
The Effects of Gum Chewing on Energy Intake and Expenditure
October 6, 2015 updated by: University of Wisconsin, Madison
The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
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
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin-Madison
-
-
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
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- BMI 27-37, between the ages of 18 and 38
Exclusion Criteria:
- 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.
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 |
---|---|
Experimental: Chewing gum
|
Subjects were instructed to chew gum at least 6 times a day in an effort to reduce snacking.
|
Placebo Comparator: Water
|
Subjects were instructed to drink 8 oz of water at least 6 times a day in an effort to reduce snacking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body composition
Time Frame: Baseline and end of study (6 weeks)
|
Baseline and end of study (6 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Leah D Whigham, PhD, Board of Regents of the University of Wisconsin System
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
September 1, 2008
Primary Completion
December 7, 2022
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
December 15, 2009
First Submitted That Met QC Criteria
January 4, 2010
First Posted (Estimate)
January 6, 2010
Study Record Updates
Last Update Posted (Estimate)
October 8, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2007-0342
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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