Status
Conditions
Treatments
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
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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:
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:
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.
Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
Unstable renal and/or liver disease
History of alcohol or drug abuse within the past year
Unstable psychiatric disorder requiring hospitalization within the past 6 months
Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
Participation in another clinical research trial within 30 days prior to randomization and during the trial
Significant abnormal liver function as defined as AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN
Serum creatinine > 125 umol/L
Anemia of any etiology defined as hemoglobin < 110 g/L
Uncontrolled and/or untreated thyroid disorder
Unstable medications (Dosage must be stable for 90 days prior to randomization)
History of food allergies or sensitivities, including lactose intolerance
Vegetarians
Cognitively impaired and/or unable to give informed consent
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
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal