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

Official Title: “The Effect of South Beach Diet™ Using South Beach Diet™ Products Compared to the American Diabetic Association Diabetes Meal Plan on Body Weight and Satiety in Overweight Diabetic Women”

The purpose of this study is to examine the effectiveness of the South Beach Diet and products compared to the American Diabetic Association Diabetes Meal Plan.

Intervention(s) in this Clinical Trial

• Behavioral: South Beach Diet with South Beach Diet Products
• Behavioral: American Diabetes Association Diabetes Meal Plan

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: South Beach Diet with SBD Products
• Active Comparator: ADA Diabetes meal plan

Primary Measures

• Change in body weight from baseline to week 24
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Assess the satiety response to the individual diets
  • Time Frame: 24 weeks
    Safety Issue?: No
• Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life
  • Time Frame: 24 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Female age 18 to 55 years
• 2. Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result
• 3. Healthy as determined by laboratory results and medical history
• 4. Waist circumference > 87 cm
• 5. Stable weight defined as < 4.5 kg gained or lost in past year
• 6. Agreement to maintain current level of physical activity throughout the study
• 7. Diagnosed with Type II diabetes mellitus with fasting blood glucose 100 - 250 mg/dl (5.6 - 13.9 mmol/L)
• 8. Ability to comprehend and complete the questionnaires and forms
• 9. Agreement to comply with study procedures, test article consumption, and has access to a microwave oven
• 10. Voluntary, written, informed consent to participate in the study

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Kraft Foods Industry

Overall Clinical Trial Officials and Contacts

David Crowley, MD Study Director KGK Synergize Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931034

Study ID Number: 07SWHK

ClinicalTrials.gov Identifier: NCT00931034

Health Authority: United States: Institutional Review Board