The Effect of Blueberry Powder Supplementation on Cardiovascular Risk Factors in Subjects With the Metabolic Syndrome

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Pre-diabetes, Metabolic syndrome, Diabetes, Hypertension, Blueberries, Anthocyanins, Insulin sensitivity, Insulin resistance Read More

Inclusion Criteria:

Men and women with metabolic syndrome and meeting all criteria listed below will be included in the study:

• Subjects ≥ 20 years of age.
• Subjects not currently treated with diabetes medication; however, Metformin use for pre-diabetes is acceptable if the subject is willing to stop taking the medication 2 weeks prior to and during the study.
• Subjects with impaired fasting glucose (100-125 mg/dL) or impaired glucose tolerance (140-199 mg/dL after 2-hr OGTT).
• Subjects with fasting insulin ≥ 10 µIU/ml.
• Subjects with a body mass index (BMI) ≥ 30 and ≤ 45.
• Subjects with hypertension: no medication (140-179 mmHg systolic or 90-109 mmHg diastolic) or currently taking antihypertensive medication.
• Written informed consent obtained PRIOR to performing any screening tests or study procedures.

Exclusion Criteria:

• Subjects with a prior history of Type 2 diabetes
• Women who are pregnant or who are lactating.
• Women of childbearing potential who are not using an effective method of birth control (i.e.,barrier method, intrauterine and cervical devices, oral contraceptives, hormonal injections (Depro Provera® ), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence), are not surgically sterilized (including tubal ligation and hysterectomy), or not at least 2 years postmenopausal. All women of childbearing potential will have a pregnancy test performed at the screening. If a subject becomes pregnant during the study, they will be dropped from the study.
• Subjects who have type 1 diabetes.
• Subjects who are currently on thiazolidinediones (rosiglitazone or pioglitazone) or who have taken these agents in the previous 12 weeks.
• Subjects who are on concomitant therapy with glucocorticoids (except topical or inhalant glucocorticoids). Other medications that have an effect on glucose homeostasis (i.e. ACE inhibitors) are acceptable if they have been administered in a stable dosage during the preceding 6 months and dosage will continue unchanged during the study.
• Subjects with a history or evidence of significant gastrointestinal dysfunction, e.g. irritable bowel syndrome; inflammatory bowel disease; ulcerative colitis or Crohn's disease; regional enteritis; diverticulosis or diverticulitis; significant gastroparesis; GI stricture, partial or complete gastrectomy or small bowel resection; autonomic neuropathy consisting of dysphasia; delayed gastric emptying or diarrhea; chronic, severe constipation; peptic ulceration, colonic ulceration, or GI bleeding.
• Subjects who have chronic use of laxatives or cathartics. The use of stool softeners is acceptable. Use of bulking agents, if required, should remain constant.
• Subjects who are taking concomitant therapy with medications known to be nephrotoxic, such as aminoglycosides, methicillin, and cyclosporin.
• Subjects who have evidence of clinically significant renal dysfunction or disease, e.g. serum creatinine >1.5 mg/dL in males and >1.4 mg/dL in females and/or BUN >50 mg/dL, proteinuria of >1 gram/day or 4+ proteinuria on dipstick urinalysis.
• Subjects with clinically significant cardiovascular dysfunction and/or history (within the preceding 6 months) of significant cardiovascular dysfunction, e.g., congestive heart failure or serious arrhythmia, myocardial infarction, cardiac surgery; transient ischemic attacks or cerebrovascular accident during the preceding six months; diagnosis of symptomatic autonomic neuropathy with a history of orthostatic hypertension, syncope, or hypertension with a systolic blood pressure of ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg at the time of screening visit.
• Subjects who have evidence within the preceding 6 months of hepatic disease or dysfunction, e.g. AST, ALT, alkaline phosphatase or total bilirubin twice the upper limit of normal; hepatitis; jaundice; cirrhosis.
• Subjects with clinically significant pulmonary, neurologic, hematologic, immunologic, neoplastic or metabolic disease.
• Subjects with evidence or recurrence of malignancy within the past five years, other than excised basal cell carcinoma.
• Subjects for whom surgery is anticipated during the study period.
• Subjects with a history of substance abuse or alcoholism within the past 5 years, or significant psychiatric disorder that would interfere with the subject's ability to complete the study.
• Subjects who have donated blood during the month prior to study entry or planned during the study.
• Subjects who have participated in other studies using an investigational drug during the preceding 3 months.
• Subjects who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
• Subjects who are allergic to blueberries.
• Subjects who are allergic to red dye or blue dye food coloring.
• Subjects who are lactose intolerant.
• Subjects who consume and drink daily servings of berries (i.e., blueberries, strawberries, bilberries, cranberries, elderberries, and raspberries), grapes, fruit juices that contain berries and grapes, and wine more than 3 times per week.
• Subjects that have had a fluctuation in body weight >5% in the preceding 2 months.
• Subjects who are taking prescription or over the counter medication or supplements for desired weight loss.
• Subjects that have peripheral vascular disease in the arms.
• Subjects that have a history of blood clots.