Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to the American Diabetic Association (ADA) Diabetes Meal Plan on Body Weight and Satiety in Diabetic Women

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 year
• Agreement to maintain current level of physical activity throughout the study
• Diagnosed with Type II diabetes mellitus with fasting blood glucose 100 - 250 mg/dl (5.6 - 13.9 mmol/L)
• 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
• Unstable medication for diabetes mellitus (Dosage must be stable for 90 days prior to randomization), use of insulin is exclusionary
• 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
• 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