NCT00932516CompletedNot Applicable
The Effect of South Beach Diet™ Using South Beach Diet™ Products Compared to a Traditional Calorie-Restricted Diet in Non-Diabetic Women
Mondelēz International, Inc.4 sites in 1 country248 target enrollmentStarted: March 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 248
- Locations
- 4
- Primary Endpoint
- Change in body weight from baseline to week 24
Study Overview
Brief Summary
The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South Beach Diet™ products compared to a traditional calorie restricted diet.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female age 18 to 55 years
- •Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result
- •Healthy as determined by laboratory results and medical history
- •Waist circumference > 87 cm
- •Stable weight defined as < 4.5 kg gained or lost in past 3 months
- •Agreement to maintain current level of physical activity throughout the study
- •Ability to comprehend and complete the questionnaires and forms
- •Agreement to comply with study procedures, test article consumption and has access to a microwave oven
- •Voluntary, written, informed consent to participate in the study
Exclusion Criteria
- •Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- •Use of prescription or over the counter products known to effect weight including but not limited to the following: megestrol acetate; somatropin; sibutramine; orlistat; paroxetine; dextroamphetamine; methylphenidate; atomoxetine; quetiapine; olanzepine; risperidone, within 4 weeks of randomization and during the trial
- •Alcohol use > 2 standard alcoholic drinks per day
- •Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
- •History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening Subjects with cancer in full remission for more than 5 years are acceptable
- •Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
- •Diabetes mellitus Type I or Type II
- •Unstable renal and/or liver disease
- •History of alcohol or drug abuse within the past year
- •Unstable psychiatric disorder requiring hospitalization within the past 6 months
- •Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- •History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
- •Participation in another clinical research trial within 30 days prior to randomization and during the trial
- •Significant abnormal liver function as defined as AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN
- •Serum creatinine > 125 umol/L
- •Anemia of any etiology defined as hemoglobin < 110 g/L
- •Uncontrolled and/or untreated thyroid disorder
- •Unstable medications (Dosage must be stable for 90 days prior to randomization)
- •History of food allergies or sensitivities including lactose intolerance
- •Vegetarians
- •Cognitively impaired and/or unable to give informed consent
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Arms & Interventions
South Beach Diet™ with SBD™ Products
Active Comparator
Intervention: South Beach Diet™ with South Beach Diet™ Products (Behavioral)
South Beach Diet™ alone
Active Comparator
Intervention: South Beach Diet™ (Behavioral)
Calorie restricted diet w/ SBD™ Products
Active Comparator
Intervention: Calorie restricted diet with South Beach Diet™ Products (Behavioral)
Calorie Restricted Diet alone
Active Comparator
Intervention: Calorie Restricted Diet (Behavioral)
Outcomes
Primary Outcomes
Change in body weight from baseline to week 24
Time Frame: 24 weeks
Secondary Outcomes
- Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life(24 weeks)
- Assess the satiety response to the individual diets(24 weeks)
Investigators
Study Sites (4)
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