Parkinson's DiseasePhase 1NCT07720869
Effects of Wild Blueberry Ingestion on Motor Performance of People With Parkinson's Disease
A Phase 1 study testing Wild blueberry powder in people with Parkinson's Disease, run by Louisiana State University, Baton Rouge at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Wild blueberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2018to 18 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
The Baton Rouge Neuromedical Center, The Spine Hospital of Louisiana
Baton Rouge, Louisiana, 70810
Sensorimotor/Motor Control Lab, Louisiana State University
Baton Rouge, Louisiana, 80803
About this study
Official title: Effects of Wild Blueberries on Motor Performance of Parkinson's Patients: A Preliminary Clinical Trial
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?
Read more
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.
Read the detailed description
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.
Week 0 involved pre-testing not completed at the physician visit with similar procedures and content to week -1. Assessments included weight, blood pressure, heart rate, temperature, pulse oxygen, updated medication list, a weekly FFQ, UPDRS-III, and functional assessments. The investigators reviewed the nutritional assessments and activity diary for accuracy, updating incomplete items, and retrieved the activity monitor. Each newly randomized participant received powder packets (BB or Placebo), pineapple juice, instructions on how to mix their drink, and adverse events diary, in which people reported the time of drink consumption and whether any adverse events occurred that day. Again, the investigators called participants three times each week through study completion to help ensure they consumed the drink and completed adverse events log and encouraged them to call investigators with questions/concerns.
During weeks 1-6, the investigators recorded weight, blood pressure, heart rate, temperature, pulse oxygen, a weekly FFQ, and reviewed the presence of adverse events, if any. Participants brought back empty packets as evidence of ingestion. Collections occurred weekly for most participants, allowing them to pick up more powder and juice for the next week. For those living farther away or with conflicts, the investigators collected as much data as possible over the phone and ensured the investigators sent home enough powder and juice until their next visit.
One week before the final visit in addition recording weight, blood pressure, heart rate, temperature, pulse oxygen, a weekly FFQ, and reviewing the presence of adverse events, the investigators reviewed and provided instructions on how to complete the 3-day food record and activity diary and how to wear the activity monitor. This occurred around week 7-8.
For the last visits (week 8 ± 1 week), the investigators repeated the visit to the neurologist after the food and PD medication (OFF) withdrawal (visit 2) and without the possible pregnancy test. During a separate visit because of the ON medication requirement, the investigators collected weight, blood pressure, heart rate, temperature, pulse oxygen, updated medication list, a weekly FFQ, UPDRS-III, and functional assessments for post-testing. The investigators reviewed the 3-day food record and activity diary for accuracy and updated incomplete items. The investigators also received the activity monitor and downloaded the data.
- Conditions
- Parkinson's Disease
- Being tested
- Wild blueberry powder, Placebo
- Keywords
- Postural Balance, Gait Analysis, Fruit and Vegetable Juices, Blueberry, Kinesiology, Applied, Fitness Trackers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wild blueberry powderDietary supplement
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%. Added to 6oz of pineapple juice.
PlaceboOther
Placebo Comparator (Placebo): Placebo drink consists of matched nutritional properties minus the polyphenols for BB powder. Added to 6oz of pineapple juice.
| Study group | Role | What they receive |
|---|---|---|
| BB | Experimental | 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%. Receives: Dietary Supplement: Wild blueberry powder |
| Placebo | Placebo comparator | Placebo Comparator (Placebo): Placebo drink consists of matched nutritional properties minus the polyphenols for BB powder. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
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).
Measured: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
COP95
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.
Measured: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
Step count
The average number of steps each day were averaged over the 7 days for a total step count.
Measured: Assessed the week prior to pre-testing and about 8 weeks (+/- 1 week) later at post-test.
The Timed-Up-and-Go (TUG) test
The investigators evaluated the time to stand from a chair, walk 3 m, turn 180º, walk back, and sit down.
Measured: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
Secondary outcomes (3)
Unified Parkinson's Disease Rating Scale-motor section (UPDRS-III)-OFF
This assessment involves an in-depth motor examination used in clinical and research settings for PD motor symptom severity ratings and assesses: 0=no, 1=slight, 2=mild, 3=moderate, 4=severe impairment. Scores categorized as ≤ 11.2 denote mild impairment, ≥ 54.4 denote severe impairment, and > 5 point changes denote clinical significance. Movement disorder neurologists performed the UPDRS-III after a 12 hour withdrawal (or 24 hour withdrawal for once daily) from anti-Parkinson medication (OFF medication).
Measured: Assessed at pre-screening and about 9 weeks later at post-test.
Gait variability
The coefficients of variation-CV was calculated across the average length of each step (SL), width of each step (SW), and duration of each step (ST). 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).
Measured: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
Postural sway
Average velocity of the center of pressure-CoP (CoPVEL), CoP displacement in the mediolateral (ML) and anteroposterior (AP) directions and their variability (SD), sample entropy of CoP displacements (SENML, SENAP) to provide insight into the automaticity of sway: https://www.mathworks.com/matlabcentral/fileexchange/35784-sample-entropy with parameters r = 0.2, and m = 2 , also normalized to participant's height. Calculated from 30 s data of standing still with eyes opened and closed, seperately.
Measured: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start31 Aug 2018
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled-randomization by coin toss with stratification by group at the end of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University, Baton Rouge
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center, Baton Rouge Neuromedical Center, The Spine Hospital of Louisiana
- Responsible party
- Principal investigator, Jan M. Hondzinski, Louisiana State University, Baton Rouge
- Investigators
- Jan M Hondzinski, PhD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720869
- Sponsor's protocol ID
- AWD-44934-1
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wild Blueberries on Motor Performance of Parkinson's Patients: A Preliminary Clinical Trial
- ClinicalTrials.gov ID
- NCT07720869
- Acronym / sponsor ID
- AWD-44934-1
- Conditions
- Parkinson's Disease
- Keywords
- Postural Balance, Gait Analysis, Fruit and Vegetable Juices, Blueberry, Kinesiology, Applied, Fitness Trackers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Louisiana State University, Baton RougeUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center, Baton Rouge Neuromedical Center, The Spine Hospital of Louisiana
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Week 0 involved pre-testing not completed at the physician visit with similar procedures and content to week -1. Assessments included weight, blood pressure, heart rate, temperature, pulse oxygen, updated medication list, a weekly FFQ, UPDRS-III, and functional assessments. The investigators reviewed the nutritional assessments and activity diary for accuracy, updating incomplete items, and retrieved the activity monitor. Each newly randomized participant received powder packets (BB or Placebo), pineapple juice, instructions on how to mix their drink, and adverse events diary, in which people reported the time of drink consumption and whether any adverse events occurred that day. Again, the investigators called participants three times each week through study completion to help ensure they consumed the drink and completed adverse events log and encouraged them to call investigators with questions/concerns.
During weeks 1-6, the investigators recorded weight, blood pressure, heart rate, temperature, pulse oxygen, a weekly FFQ, and reviewed the presence of adverse events, if any. Participants brought back empty packets as evidence of ingestion. Collections occurred weekly for most participants, allowing them to pick up more powder and juice for the next week. For those living farther away or with conflicts, the investigators collected as much data as possible over the phone and ensured the investigators sent home enough powder and juice until their next visit.
One week before the final visit in addition recording weight, blood pressure, heart rate, temperature, pulse oxygen, a weekly FFQ, and reviewing the presence of adverse events, the investigators reviewed and provided instructions on how to complete the 3-day food record and activity diary and how to wear the activity monitor. This occurred around week 7-8.
For the last visits (week 8 ± 1 week), the investigators repeated the visit to the neurologist after the food and PD medication (OFF) withdrawal (visit 2) and without the possible pregnancy test. During a separate visit because of the ON medication requirement, the investigators collected weight, blood pressure, heart rate, temperature, pulse oxygen, updated medication list, a weekly FFQ, UPDRS-III, and functional assessments for post-testing. The investigators reviewed the 3-day food record and activity diary for accuracy and updated incomplete items. The investigators also received the activity monitor and downloaded the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled-randomization by coin toss with stratification by group at the end of the study.
| Arm | Type | Receives |
|---|---|---|
| BB | Experimental | Dietary Supplement: Wild blueberry powderExperimental (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%. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Comparator (Placebo): Placebo drink consists of matched nutritional properties minus the polyphenols for BB powder. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wild blueberry powderExperimental (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%. Added to 6oz of pineapple juice. | Dietary supplement | BB |
| PlaceboPlacebo Comparator (Placebo): Placebo drink consists of matched nutritional properties minus the polyphenols for BB powder. Added to 6oz of pineapple juice. | Other | Placebo |
Primary outcome
Gait velocity
Time frame: 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).
COP95
Time frame: 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
Time frame: 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.
The Timed-Up-and-Go (TUG) test
Time frame: 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.
3 secondary outcomes
Unified Parkinson's Disease Rating Scale-motor section (UPDRS-III)-OFF
Time frame: Assessed at pre-screening and about 9 weeks later at post-test.
Gait variability
Time frame: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
Postural sway
Time frame: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan M Hondzinski, PhD principal investigator
Louisiana State University Health Sciences Center in New Orleans
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wild blueberry powder in people with Parkinson's Disease, run by Louisiana State University, Baton Rouge at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (time frame: Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.