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

Exclusion Criteria

• •1. Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• •2. 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
• •3. Unstable medication for diabetes mellitus (Dosage must be stable for 90 days prior to randomization), use of insulin is exclusionary
• •4. Alcohol use \> 2 standard alcoholic drinks per day
• •5. 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)
• •6. 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.
• •7. Uncontrolled hypertension defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg
• •8. Unstable renal and/or liver disease
• •9. History of alcohol or drug abuse within the past year
• •10. Unstable psychiatric disorder requiring hospitalization within the past 6 months
• •11. Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
• •12. History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
• •13. Participation in another clinical research trial within 30 days prior to randomization and during the trial
• •14. Significant abnormal liver function as defined as AST and/or ALT \> 2 x ULN, and/or bilirubin \> 2 x ULN
• •15. Serum creatinine \> 125 umol/L
• •16. Anemia of any etiology defined as hemoglobin \< 110 g/L
• •17. Uncontrolled and/or untreated thyroid disorder
• •18. Unstable medications (Dosage must be stable for 90 days prior to randomization)
• •19. History of food allergies or sensitivities, including lactose intolerance
• •20. Vegetarians
• •21. Cognitively impaired and/or unable to give informed consent
• •22. 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