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Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to the American Diabetic Association (ADA) Diabetes Meal Plan on Body Weight and Satiety in Diabetic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931034
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : July 2, 2009
KGK Science Inc.
Information provided by:
Mondelēz International, Inc.

Brief Summary:
The purpose of this study is to examine the effectiveness of the South Beach Diet and products compared to the American Diabetic Association Diabetes Meal Plan.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: South Beach Diet with South Beach Diet Products Behavioral: American Diabetes Association Diabetes Meal Plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 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 the American Diabetic Association Diabetes Meal Plan on Body Weight and Satiety in Overweight Diabetic Women
Study Start Date : March 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: South Beach Diet with SBD Products Behavioral: South Beach Diet with South Beach Diet Products
Active Comparator: ADA Diabetes meal plan Behavioral: American Diabetes Association Diabetes Meal Plan

Primary Outcome Measures :
  1. Change in body weight from baseline to week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Assess the satiety response to the individual diets [ Time Frame: 24 weeks ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 year
  6. Agreement to maintain current level of physical activity throughout the study
  7. Diagnosed with Type II diabetes mellitus with fasting blood glucose 100 - 250 mg/dl (5.6 - 13.9 mmol/L)
  8. Ability to comprehend and complete the questionnaires and forms
  9. Agreement to comply with study procedures, test article consumption, and has access to a microwave oven
  10. 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. Unstable medication for diabetes mellitus (Dosage must be stable for 90 days prior to randomization), use of insulin is exclusionary
  4. Alcohol use > 2 standard alcoholic drinks per day
  5. 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)
  6. 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.
  7. Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931034

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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, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, New York
Rochester Clinical Research Inc
Rochester, New York, United States, 14609
United States, Virginia
Chase Wellness & Research Center
Virginia Beach, Virginia, United States, 23455
Sponsors and Collaborators
Mondelēz International, Inc.
KGK Science Inc.
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Study Director: David Crowley, MD KGK Science Inc.
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Responsible Party: Richard Black, PhD/VP, Nutrition, Kraft Foods Identifier: NCT00931034    
Other Study ID Numbers: 07SWHK
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009
Keywords provided by Mondelēz International, Inc.:
South Beach Diet™
weight loss
Additional relevant MeSH terms:
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Diabetes Mellitus
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms