Working… Menu

Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00932516
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : July 3, 2009
KGK Science Inc.
Information provided by:
Mondelēz International, Inc.

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.

Condition or disease Intervention/treatment Phase
Overweight Behavioral: South Beach Diet™ with South Beach Diet™ Products Behavioral: South Beach Diet™ Behavioral: Calorie restricted diet with South Beach Diet™ Products Behavioral: Calorie Restricted Diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of South Beach Diet™ Using South Beach Diet™ Products Compared to a Traditional Calorie-Restricted Diet in Non-Diabetic Women
Study Start Date : March 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Active Comparator: South Beach Diet™ with SBD™ Products Behavioral: South Beach Diet™ with South Beach Diet™ Products
Active Comparator: South Beach Diet™ alone Behavioral: South Beach Diet™
Active Comparator: Calorie restricted diet w/ SBD™ Products Behavioral: Calorie restricted diet with South Beach Diet™ Products
Active Comparator: Calorie Restricted Diet alone Behavioral: Calorie Restricted Diet

Primary Outcome Measures :
  1. Change in body weight from baseline to week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Assess the satiety response to the individual diets [ Time Frame: 24 weeks ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00932516

Layout table for location information
United States, California
Medicus Research
Northridge, California, United States, 91325
United States, Florida
SIBR Research
Bradenton, Florida, United States, 34205
Miami Research Associates
Miami, Florida, United States, 33143
United States, Virginia
Chase Wellness & Research Center
Virginia Beach, Virginia, United States, 23455
Sponsors and Collaborators
Mondelēz International, Inc.
KGK Science Inc.
Layout table for investigator information
Study Director: David Crowley, MD KGK Science Inc.

Layout table for additonal information
Responsible Party: Richard Black, PhD/VP, Nutrition, Kraft Foods Identifier: NCT00932516     History of Changes
Other Study ID Numbers: 07SWHK-NONDIABETIC
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: July 3, 2009
Last Verified: July 2009
Keywords provided by Mondelēz International, Inc.:
South Beach Diet™
weight loss
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Signs and Symptoms