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

NCT07720869

CompletedPhase 1

Sponsor: Louisiana State University, Baton Rouge

Conditions: Parkinson's Disease

Interventions: Wild blueberry powder, Placebo

Countries: United States

The purpose of this study involved investigating the effects of daily ingested wild blueberry drink (22.5 g wild blueberry powder added to pineapple juice) for 8 weeks on movement of people diagnosed with Parkinson's disease. Specifically, the investigators questioned: * Do the movements of people with Parkinson's disease improve after ingesting the blueberry drink once a day for 8 weeks? * Do the movements of people with Parkinson's disease after ingesting the blueberry drink show benefits compared to people with Parkinson's ingesting a placebo drink? Participants will: * Drink blueberry drink or placebo once a day for 8 weeks * Visit the neurologist before and after the intervention period * Complete assessments before and after the intervention period * Visit the lab weekly for checkups and to obtain more powder and juice * Keep a diary of time of ingestion and adverse effects. The investigators hypothesized that supplementation with wild blueberry powder will result in favorable improvements in movements in people with Parkinson's disease that exceed placebo supplementation.

Eligibility overview

Sex: ALL

Age: 50 Years to 89 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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.

Exclusion Criteria:

* Subjects with prior history of Type 1 or uncontrolled Type 2 diabetes (A1C \> 7%).
* 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 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 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 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 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 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 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 or has had surgery in the last 6-months.
* 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 allergic to blueberries or pineapple juice.
* Subjects who are allergic to red dye or blue dye food coloring.
* 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 are taking prescription or over the counter medication or supplements for desired weight loss.
* Subjects who have peripheral vascular disease in the arms and/or legs.
* Subjects who have a history of blood clots.
* Subjects who have active deep brain stimulators.
Locations (3)
  • Baton Rouge, Louisiana, United States
  • Baton Rouge, Louisiana, United States
  • Baton Rouge, Louisiana, United States