Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women

Sponsor

Mondelēz International, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00932516

Collaborator

KGK Science Inc. (Industry)

248

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

248 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Change in body weight from baseline to week 24 [24 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Medicus Research	Northridge	California	United States	91325
2	SIBR Research	Bradenton	Florida	United States	34205
3	Miami Research Associates	Miami	Florida	United States	33143
4	Chase Wellness & Research Center	Virginia Beach	Virginia	United States	23455