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Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT00932516•Mondelēz International, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female age 18 to 55 years
•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

•1. Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
•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
+12 more criteria

Locations (4)

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

Key Dates

Start Date

March 1, 2007

Primary Completion Date

March 1, 2008

Completion Date

April 1, 2008

Last Updated

July 3, 2009

Enrollment

248

ACTUAL participants

Conditions

Overweight

Interventions

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

BEHAVIORAL

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

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RECRUITINGNA

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

NCT07237750

Overweight and/or ObesityMetabolic Syndrome+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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