Overweight
Conditions
Keywords
South Beach Diet™, overweight, obesity, satiety, weight loss
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.
Interventions
BEHAVIORALSouth Beach Diet™ with South Beach Diet™ Products
BEHAVIORALSouth Beach Diet™
BEHAVIORALCalorie restricted diet with South Beach Diet™ Products
BEHAVIORALCalorie Restricted Diet
Sponsors
KGK Science Inc.
Mondelēz International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
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 3 months 6. Agreement to maintain current level of physical activity throughout the study 7. Ability to comprehend and complete the questionnaires and forms 8. Agreement to comply with study procedures, test article consumption and has access to a microwave oven 9. 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. Alcohol use \> 2 standard alcoholic drinks per day 4. 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) 5. 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 6. Uncontrolled hypertension defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg 7. Diabetes mellitus Type I or Type II 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to week 24 | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assess the satiety response to the individual diets | 24 weeks |
| Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life | 24 weeks |
Countries
United States
Outcome results
None listed