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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00931034
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-04
• Study Completion: 2008-07
• Status Verified: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-30
• Last Update Submitted: 2009-06-30
• Study First Posted: 2009-07-02
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in body weight from baseline to week 24	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

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