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

Mondelez International

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: American Diabetes Association Diabetes Meal Plan; Behavioral: South Beach Diet with South Beach Diet Products

Study type: Interventional

Funder types: Industry

Identifiers

NCT00931034

07SWHK

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

South Beach Diet with SBD Products

Active Comparator group

Treatment:

Behavioral: South Beach Diet with South Beach Diet Products

ADA Diabetes meal plan

Active Comparator group

Treatment:

Behavioral: American Diabetes Association Diabetes Meal Plan