Effects of Wild Blueberry Ingestion on Motor Performance of People With Parkinson's Disease

Prior treatment

• Subjects with prior history of Type 1 or uncontrolled Type 2 diabetes (A1C \> 7%).
• Subjects who are taking concomitant therapy with medications known to be nephrotoxic, such as aminoglycosides, methicillin, and cyclosporin.
• Subjects for whom surgery is anticipated during the study period or has had surgery in the last 6-months.
• 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 taking prescription or over the counter medication or supplements for desired weight loss.

Other illness

• Subjects with diagnosed osteoarthritic conditions of the spine or lower extremities (including hips) sufficient to affect gait.
• Subjects with pre-existing medical condition that significantly affects gait.
• 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; chronic diarrhea; peptic ulceration, colonic ulceration, or GI bleeding.
• 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 or myocardial infarction; 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; history of hypotension, dizziness/fainting with systolic blood pressure of ≤ 90 mm Hg or diastolic blood pressure ≤ 60 mm Hg at the time of screening visit.
• 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 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 are allergic to blueberries or pineapple juice.
• Subjects who are allergic to red dye or blue dye food coloring.
• Subjects who have peripheral vascular disease in the arms and/or legs.
• Subjects who have a history of blood clots.

Lab values

• 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 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.

Other

• Subjects who are demented.
• Subjects who have severe difficulty swallowing.
• Subjects with diagnosis or signs of neuropathy.
• Subjects with evidence of rheumatoid arthritis.
• Subjects with pre-existing gait defect (unless caused by PD).
• 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.
• 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 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 in the preceding 2 months.
• Subjects who have had a fluctuation in body weight \>10% in the preceding 2 months.
• Subjects who have active deep brain stimulators.

• Men and women diagnosed with Stage 1-3 Parkinson's disease (Hoehn \& Yahr) as confirmed at the first screening visit by the study neurologist and meeting all criteria listed below will be included in the study:
• 50-89 years of age.
• BMI 18.5-40.
• Stable on medications for at least 2 months.
• Walks w/o assistive device.
• Maintain consistent activity levels for 30 days prior to and during study.
• Willing to consume 22.5 mg of mixed powder added to pineapple juice a day for 8 weeks.