Chewing Gum for Weight Loss
Obesity, Overweight, Weight Loss
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, weight loss, randomized controlled trial, chewing gum
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University of Alabama at Birmingham Division of Preventive Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Nutrition brochure
Chewing gum + nutrition brochure
Control participants will receive only a nutrition brochure, Finding Your Way to a Healthier You, based on a USDHHS/USDA publication, Dietary Guidelines for Americans 2005.
Participants in the experimental arm will be instructed to incorporate gum chewing in their diet with a goal of at least 90 minutes per day. The schedule is 20 minutes each after breakfast, lunch and dinner plus 10 minutes mid-morning, mid-afternoon and 1 to 2 hours after dinner. Experimental participants also will be told to chew gum instead of unplanned eating in response to hunger, cravings, preoccupation with eating, or negative feelings.