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Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women
This study has been completed.
First Received: June 30, 2009   Last Updated: July 2, 2009   History of Changes
Sponsors and Collaborators: Kraft Foods
KGK Synergize Inc.
Information provided by: Kraft Foods
ClinicalTrials.gov Identifier: NCT00932516
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: The Effect of South Beach Diet™ Using South Beach Diet™ Products Compared to a Traditional Calorie-Restricted Diet in Non-Diabetic Women

Resource links provided by NLM:


Further study details as provided by Kraft Foods:

Primary Outcome Measures:
  • Change in body weight from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the satiety response to the individual diets [ Time Frame: 24 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
South Beach Diet™ with SBD™ Products: Active Comparator Behavioral: South Beach Diet™ with South Beach Diet™ Products
South Beach Diet™ alone: Active Comparator Behavioral: South Beach Diet™
Calorie restricted diet w/ SBD™ Products: Active Comparator Behavioral: Calorie restricted diet with South Beach Diet™ Products
Calorie Restricted Diet alone: Active Comparator Behavioral: Calorie Restricted Diet

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932516

Locations
United States, California
Medicus Research
Northridge, California, United States, 91325
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
SIBR Research
Bradenton, Florida, United States, 34205
United States, Virginia
Chase Wellness & Research Center
Virginia Beach, Virginia, United States, 23455
Sponsors and Collaborators
Kraft Foods
KGK Synergize Inc.
Investigators
Study Director: David Crowley, MD KGK Synergize Inc.
  More Information

No publications provided

Responsible Party: Kraft Foods ( Richard Black, PhD/VP, Nutrition )
Study ID Numbers: 07SWHK-NONDIABETIC
Study First Received: June 30, 2009
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00932516     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Kraft Foods:
South Beach Diet™
overweight
obesity
satiety
weight loss

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Overweight

ClinicalTrials.gov processed this record on September 10, 2009