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
Completed · Not applicable
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00931034
- Run by
- Mondelēz International, Inc.
- People needed
- 120
- Starts
- 2007-03-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2009-07-02
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female age 18 to 55 years
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result
- Healthy as determined by laboratory results and medical history
- Waist circumference > 87 cm
- Stable weight defined as < 4.5 kg gained or lost in past year
- Agreement to maintain current level of physical activity throughout the study
- Diagnosed with Type II diabetes mellitus with fasting blood glucose 100 - 250 mg/dl (5.6 - 13.9 mmol/L)
- Ability to comprehend and complete the questionnaires and forms
- Agreement to comply with study procedures, test article consumption, and has access to a microwave oven
- Voluntary, written, informed consent to participate in the study
You may not qualify if…
- Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- 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
- Unstable medication for diabetes mellitus (Dosage must be stable for 90 days prior to randomization), use of insulin is exclusionary
- Alcohol use > 2 standard alcoholic drinks per day
- 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)
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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