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Sponsors and Collaborators: |
Kraft Foods KGK Synergize Inc. |
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Information provided by: | Kraft Foods |
ClinicalTrials.gov Identifier: | NCT00932516 |
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 |
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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 |
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 |
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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 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | David Crowley, MD | KGK Synergize Inc. |
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 |
South Beach Diet™ overweight obesity satiety weight loss |
Body Weight Signs and Symptoms Obesity Weight Loss Overweight |
Body Weight Signs and Symptoms Overweight |