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

NCT ID: NCT00931034

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-07-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

South Beach Diet with SBD Products

Group Type: ACTIVE_COMPARATOR

South Beach Diet with South Beach Diet Products

Intervention Type: BEHAVIORAL

ADA Diabetes meal plan

Group Type: ACTIVE_COMPARATOR

American Diabetes Association Diabetes Meal Plan

Intervention Type: BEHAVIORAL

Interventions

South Beach Diet with South Beach Diet Products

Intervention Type: BEHAVIORAL

American Diabetes Association Diabetes Meal Plan

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Kraft Foods

Principal Investigators

David Crowley, MD

Role: STUDY_DIRECTOR

KGK Science Inc.

Locations

Medicus Research

Northridge, California, United States

SIBR Research

Bradenton, Florida, United States

Miami Research Associates

Miami, Florida, United States

Nevada Alliance Against Diabetes

Las Vegas, Nevada, United States

Rochester Clinical Research Inc

Rochester, New York, United States

Chase Wellness & Research Center

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

07SWHK

Identifier Type: -

Identifier Source: org_study_id