Chewing Gum for Weight Loss

NCT00971347 | Completed

• 1 other identifier: 000354619
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 be otherwise healthy and ages 19-50. The control group will receive only printed information on optimal diet and increasing physical activity. The intervention group will be instructed to chew gum following meals and in place of snacks for a minimum of 90 minutes per day. The intervention group also will receive the same information on optimal diet and increasing physical activity as the control group. In this 8-week intervention, the primary outcome will be change in body weight, and secondary outcomes will be changes in body mass income (BMI), waist circumference, and blood pressure. The protocol includes 3 clinic visits to assess outcomes: baseline, 4 weeks after randomization, and 8 weeks after randomization. Adherence to the gum chewing protocol will be assessed at clinic visits and during 2 telephone calls at 2 weeks and 6 weeks post-randomization. The investigators' hypothesis is that gum-chewers will lose more weight than those who receive information only.

Conditions

Obesity; Overweight; Weight Loss

Keywords

obesity; overweight; weight loss; randomized controlled trial; chewing gum

Outcome Measures

Primary Outcomes (1)

• weight change in kg

  8 weeks

Secondary Outcomes (3)

• Body mass index in kilograms per meter-squared

  8 weeks

• waist circumference in cm

  8 weeks

• blood pressure in mm of mercury

  8 weeks

Study Arms (2)

Nutrition brochure

ACTIVE COMPARATOR

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.

Behavioral: nutrition brochure

Chewing gum + nutrition brochure

EXPERIMENTAL

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.

Other: Extra sugar-free chewing gum sticks; Behavioral: nutrition brochure

Interventions

Extra sugar-free chewing gum sticks OTHER

90 minutes chewing per day after meals; mid-morning and mid-afternoon; 1 to 2 hours after dinner; and in response to hunger, cravings, preoccupation with eating, or negative feelings in general throughout the day.

Also known as: Extra sugar-free chewing gum

Chewing gum + nutrition brochure

nutrition brochure BEHAVIORAL

one-time at baseline visit

Also known as: Finding Your Way to a Healthier You (GPO 001-000-04718-3)

Chewing gum + nutrition brochure; Nutrition brochure

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Wm. Wrigley Jr. Company: collaborator

Study Sites (1)

University of Alabama at Birmingham Division of Preventive Medicine

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• David B. Allison, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• James M. Shikany, DrPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 23, 2010

Record last verified: 2010-11

Locations

US (1)