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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931034
• Other study ID #: 07SWHK
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: June 30, 2009
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2009
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• South Beach Diet with South Beach Diet Products

• American Diabetes Association Diabetes Meal Plan

Locations

Country	Name	City	State
United States	SIBR Research	Bradenton	Florida
United States	Nevada Alliance Against Diabetes	Las Vegas	Nevada
United States	Miami Research Associates	Miami	Florida
United States	Medicus Research	Northridge	California
United States	Rochester Clinical Research Inc	Rochester	New York
United States	Chase Wellness & Research Center	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Mondelez International, Inc.	KGK Synergize Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight from baseline to week 24		24 weeks	No
Secondary	Assess the satiety response to the individual diets		24 weeks	No
Secondary	Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life		24 weeks	No