Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women
This study has been completed.
Sponsor:
Mondelēz International, Inc.
Collaborator:
KGK Synergize Inc.
Information provided by:
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT00932516
First received: June 30, 2009
Last updated: July 2, 2009
Last verified: July 2009
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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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Further study details as provided by Mondelēz International, Inc.:
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 |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Anemia of any etiology defined as hemoglobin < 110 g/L
- Uncontrolled and/or untreated thyroid disorder
- Unstable medications (Dosage must be stable for 90 days prior to randomization)
- History of food allergies or sensitivities including lactose intolerance
- Vegetarians
- Cognitively impaired and/or unable to give informed consent
- 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 | |
| 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 Synergize Inc.
Investigators
| Study Director: | David Crowley, MD | KGK Synergize Inc. |
More Information
No publications provided
| Responsible Party: | Richard Black, PhD/VP, Nutrition, Kraft Foods |
| ClinicalTrials.gov Identifier: | NCT00932516 History of Changes |
| Other Study ID Numbers: | 07SWHK-NONDIABETIC |
| Study First Received: | June 30, 2009 |
| Last Updated: | July 2, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mondelēz International, Inc.:
|
South Beach Diet™ overweight obesity satiety weight loss |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013