Status:
COMPLETED
Chewing Gum for Weight Loss
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Wm. Wrigley Jr. Company
Conditions:
Obesity
Overweight
Eligibility:
All Genders
19-50 years
Phase:
NA
Brief Summary
This is a randomized controlled trial of the effects of chewing gum on body weight. The investigators will randomly assign 200 overweight or mildly obese adults to one of two groups. Participants must...
Detailed Description
In this randomized controlled trial of the effects of chewing gum on body weight, we will randomly assign 200 overweight or mildly obese, but otherwise healthy adults (men and women, ages 19 to 50), t...
Eligibility Criteria
Inclusion
- 19 - 50 years of age
- BMI 25 - 35 kg/m2
- Non-diabetic; no previous history of diabetes
- Fasting glucose \<126 mg/dL at recruitment
- Male or female
- Any race or ethnicity
Exclusion
- Any major disease including:
- Active cancer or cancer requiring treatment \< 2 years (except nonmelanoma skin cancer).
- Active or chronic infections including self-reported HIV and active tuberculosis.
- Active cardiovascular disease or event with hospitalization; or therapeutic procedures for treatment of heart disease \<6 months; or New York Heart Association Functional Class \>2 for congestive heart failure, stroke or transient ischemic attack \< 6 months.
- Uncontrolled hypertension: ≥SBP 160 mm Hg or DBP ≥95 mm Hg on treatment.
- GI disease: self-reported chronic hepatitis or cirrhosis; alcoholic hepatitis or alcoholic pancreatitis \< 12 months; inflammatory bowel disease treatment \< 12 months; recent or significant abdominal surgery.
- Renal disease: serum creatinine ≥1.4 mg/dL (124 μmol/L) for men; ≥1.3 mg/dL (115 μmol/L) for women.
- Lung disease: chronic obstructive airway disease with use of oxygen.
- Diagnosed diabetes (type 1 or 2), fasting hyperglycemia (blood glucose ≥ 126 mg/dL), or use of any anti-diabetic medications.
- Uncompensated or uncontrolled psychiatric disease that would impede conduct of the trial or completion of procedures.
- Phenylketonuria.
- Temporomandibular joint disorders.
- \< 16 natural, fully crowned, or restored teeth in a good state of repair.
- Inadequate oral hygiene.
- Sensitivity to flavors, sweeteners, or other ingredients in sugar-free chewing gum.
- Refusal to chew gum per study guidelines.
- Currently chewing ≥5 sticks of gum per week.
- Weight loss or gain of \>10% in the past 6 months except post-partum weight loss.
- Current participation in any weight-reduction program.
- Current smoker or quit \< 6 months.
- History of prior surgical procedure for weight control or liposuction.
- Unable or unwilling to give informed consent; unable to communicate with clinic staff; another household member is a participant or staff member in the trial; unwilling to accept randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away before trial completed; unable to walk 0.25 mile in 10 minutes.
- Currently pregnant or \< 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the trial; unwilling to take adequate contraceptive measures if potentially fertile.
- Brief Symptom Inventory score (Derogatis \& Melisaratos, 1983) \> 90th percentile.
- Any active use of illegal or illicit drugs or history of such use \< 12 months. Excessive alcohol intake, acute or chronic: average consumption of 3+ alcohol containing beverages daily; consumption of 7+ alcoholic beverages within a 24-hr period \<12 months; or other evidence available to clinic staff. Subject may still be considered eligible if, upon explanation, the clinic staff believe that the volunteer can and will limit future intake.
- This is a partial listing; complete list available from PIs.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00971347
Start Date
August 1 2009
End Date
June 1 2010
Last Update
November 23 2010
Active Locations (1)
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1
University of Alabama at Birmingham Division of Preventive Medicine
Birmingham, Alabama, United States, 35205