Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women
The Effect of South Beach Diet™ Using South Beach Diet™ Products Compared to a Traditional Calorie-Restricted Diet in Non-Diabetic Women
1 other identifier
interventional
248
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2007
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 3, 2009
CompletedJuly 3, 2009
July 1, 2009
1 year
June 30, 2009
July 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight from baseline to week 24
24 weeks
Secondary Outcomes (2)
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
Study Arms (4)
South Beach Diet™ with SBD™ Products
ACTIVE COMPARATORSouth Beach Diet™ alone
ACTIVE COMPARATORCalorie restricted diet w/ SBD™ Products
ACTIVE COMPARATORCalorie Restricted Diet alone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Female age 18 to 55 years
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result
- Healthy as determined by laboratory results and medical history
- Waist circumference \> 87 cm
- Stable weight defined as \< 4.5 kg gained or lost in past 3 months
- Agreement to maintain current level of physical activity throughout the study
- Ability to comprehend and complete the questionnaires and forms
- Agreement to comply with study procedures, test article consumption and has access to a microwave oven
- Voluntary, written, informed consent to participate in the study
You may not qualify if:
- Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- 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
- Alcohol use \> 2 standard alcoholic drinks per day
- 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)
- 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
- Uncontrolled hypertension defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg
- Diabetes mellitus Type I or Type II
- Unstable renal and/or liver disease
- History of alcohol or drug abuse within the past year
- Unstable psychiatric disorder requiring hospitalization within the past 6 months
- Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
- Participation in another clinical research trial within 30 days prior to randomization and during the trial
- Significant abnormal liver function as defined as AST and/or ALT \> 2 x ULN, and/or bilirubin \> 2 x ULN
- Serum creatinine \> 125 umol/L
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mondelēz International, Inc.lead
- KGK Science Inc.collaborator
Study Sites (4)
Medicus Research
Northridge, California, 91325, United States
SIBR Research
Bradenton, Florida, 34205, United States
Miami Research Associates
Miami, Florida, 33143, United States
Chase Wellness & Research Center
Virginia Beach, Virginia, 23455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Crowley, MD
KGK Science Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 3, 2009
Study Start
March 1, 2007
Primary Completion
March 1, 2008
Study Completion
April 1, 2008
Last Updated
July 3, 2009
Record last verified: 2009-07