Effects of Wild Blueberries on Motor Performance of Parkinson's Patients: A Preliminary Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- COP95
研究概览
简要总结
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.
详细描述
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? 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.
Drinks After meeting entry criteria, people were randomized to receive 22.5 g of wild blueberry powder (equivalent to 1 cup of wild blueberries) or control/placebo added to 170 g of pineapple juice with about four ice cubes and consumed as one drink per day. Participants received at least seven individual powder packets sealed in a baggy along with at least eight 6 oz cans of 100% Dole pineapple juice for each week of the intervention (the investigators included extra in anticipation of rescheduling or mishandling). Most people used their own blender for mixing the drink; however, a few used the shaker bottles with stainless steel wire whisk. Participants returned empty packets, as confirmation of ingestion, during lab visits.
Freeze-dried wild blueberry powder included quick frozen and dehydrated wild blueberries to reduce the moisture content to approximately 2-4%. Placebo matched nutritional properties minus the polyphenols. The Wild Blueberry Association of North America provided BB and placebo powder.
Three pre-screening visits allowed us to ensure participants met study criteria and to start pre-intervention assessments. During visit 1/week -3, the investigators obtained consent, surveyed inclusion/exclusion criteria, measured height and weight, assessed cognition (Mini Mental State Exam), obtained a list of concomitant medication, and completed the taste test to ensure participants agreed to consume either the Placebo and BB drinks for 8 weeks. During visit 2/week -2 and after a 12 hour OFF PD medication (24 hour for dosing once daily) and food withdrawal, participants saw a movement disorder neurologist to complete a physical and neural examination including non-dilated fundoscopic evaluation, obtain vitals, obtain medical history and concomitant medication, assess Hoehn and Yahr stage of PD, and assess motor symptom severity via the Unified Parkinson's Disease Rating Scale (UPDRS-III). Predetermined laboratory assessments at this visit included pregnancy test (if applicable), urinalysis, fasting glucose, and insulin, CHEM 15, and a CBC panel. Visit 3/week -1 involved collection of weight, blood pressure, heart rate, temperature, pulse oxygen, updated medication list, a weekly Food Frequency Questionnaire (FFQ) to determine how many berries, grapes, cherries, juices, or wine people consumed in the previous week, UPDRS-III, and functional assessments to expose participants to objective and clinical measures of standing balance, gait, and physical function used for pre and post intervention while on their normal medication schedule. The investigators explained and provided instructions on how to complete nutritional assessments involving a 3-day food record which included details about all food consumption for 3 non-consecutive days (time, location, what, and how much consumed) and a Diet History Questionnaire II requesting what, how often, and how much they ate of different foods over the last year. Researchers instructed participants how to wear a waist-mounted activity monitor for seven days and provided verbal and written instructions to record the start time and type of each activity in an activity diary. The investigators called participants three times during the next seven days to help ensure adherence. The investigators also encouraged participants to call investigators with questions/concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Outcomes assessor was masked for the initial data analyses but unmasked for follow-up analyses.
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
BB
Experimental (BB): The experimental powder consists freeze-dried wild blueberry powder included quick frozen and dehydrated wild blueberries to reduce the moisture content to approximately 2-4%.
干预措施: Wild blueberry powder (Dietary Supplement)
Placebo
Placebo Comparator (Placebo): Placebo drink consists of matched nutritional properties minus the polyphenols for BB powder.
干预措施: Placebo (Other)
结局指标
主要结局
COP95
时间窗: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
The area containing the 95% confidence ellipse encompassing the center of pressure-CoP during 30 s of standing still with either eyes opened or closed.
Step count
时间窗: Assessed the week prior to pre-testing and about 8 weeks (+/- 1 week) later at post-test.
The average number of steps each day were averaged over the 7 days for a total step count.
Gait velocity
时间窗: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
The average time per meter it takes participants to complete their steps across a 20-foot computerized walkway. Assessment occurred under three conditions: 1) normal walking, 2) fast walking, and 3) dual-task walking (the investigators asked participants to spell a five-letter word backwards as they crossed the walkway).
The Timed-Up-and-Go (TUG) test
时间窗: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
The investigators evaluated the time to stand from a chair, walk 3 m, turn 180º, walk back, and sit down.
次要结局
- Unified Parkinson's Disease Rating Scale-motor section (UPDRS-III)-OFF(Assessed at pre-screening and about 9 weeks later at post-test.)
- Postural sway(Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.)
- Gait variability(Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.)
研究者
Jan M. Hondzinski
Professor
Louisiana State University, Baton Rouge