ObesityNCT01043471
The Effects of Gum Chewing on Energy Intake and Expenditure
A study testing Chewing gum and Water in people with Obesity, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Chewing gum and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 27-37, between the ages of 18 and 38
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumOther
Subjects were instructed to chew gum at least 6 times a day in an effort to reduce snacking.
WaterOther
Subjects were instructed to drink 8 oz of water at least 6 times a day in an effort to reduce snacking.
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum | Experimental | Not described Receives: Other: Chewing gum |
| Water | Placebo comparator | Not described Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition
Measured: Baseline and end of study (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startSep 2008
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- The Obesity Society
- Responsible party
- Sponsor
- Investigators
- Leah D Whigham, PhD, Principal investigator, Board of Regents of the University of Wisconsin System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043471
- Sponsor's protocol ID
- H-2007-0342
- Status last verified
- Oct 2015
- First submitted
- 15 Dec 2009
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gum Chewing on Energy Intake and Expenditure
- ClinicalTrials.gov ID
- NCT01043471
- Acronym / sponsor ID
- H-2007-0342
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- The Obesity Society
- Study start
- Sep 2008
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum | Experimental | Other: Chewing gum |
| Water | Placebo comparator | Other: Water |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 27-37, between the ages of 18 and 38
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing gumSubjects were instructed to chew gum at least 6 times a day in an effort to reduce snacking. | Other | Chewing gum |
| WaterSubjects were instructed to drink 8 oz of water at least 6 times a day in an effort to reduce snacking. | Other | Water |
Primary outcome
Change in body composition
Time frame: Baseline and end of study (6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah D Whigham, PhD principal investigator
Board of Regents of the University of Wisconsin System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing gum and Water in people with Obesity, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (time frame: Baseline and end of study (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.