Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women
NCT ID: NCT00932516
Last Updated: 2009-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2007-03-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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South Beach Diet™ with SBD™ Products
South Beach Diet™ with South Beach Diet™ Products
South Beach Diet™ alone
South Beach Diet™
Calorie restricted diet w/ SBD™ Products
Calorie restricted diet with South Beach Diet™ Products
Calorie Restricted Diet alone
Calorie Restricted Diet
Interventions
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South Beach Diet™ with South Beach Diet™ Products
South Beach Diet™
Calorie restricted diet with South Beach Diet™ Products
Calorie Restricted Diet
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
FEMALE
No
Sponsors
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KGK Science Inc.
INDUSTRY
Mondelēz International, Inc.
INDUSTRY
Responsible Party
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Kraft Foods
Principal Investigators
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David Crowley, MD
Role: STUDY_DIRECTOR
KGK Science Inc.
Locations
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Medicus Research
Northridge, California, United States
SIBR Research
Bradenton, Florida, United States
Miami Research Associates
Miami, Florida, United States
Chase Wellness & Research Center
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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07SWHK-NONDIABETIC
Identifier Type: -
Identifier Source: org_study_id
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