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

NCT07720869 | Completed Phase 1 FDA Drug

• 1 other identifier: AWD-44934-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Parkinson's Disease

Keywords

Postural Balance; Gait Analysis; Fruit and Vegetable Juices; Blueberry; Kinesiology, Applied; Fitness Trackers

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  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

  Assessed at pre-screening and about 9 weeks 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.

• 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.

Other Outcomes (3)

• Unified Parkinson's Disease Rating Scale-motor section (UPDRS-III) ON medication

  Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.

• Spatial-temporal gait measures

  Assessed during practice, one week prior to pre-test, and at pre-test and about 8 weeks (+/- 1 week) later at post-test.

• Physical activity level

  Assessed the week prior to pre-testing and about 8 weeks (+/- 1 week) later at post-test.

Study Arms (2)

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%.

Dietary Supplement: Wild blueberry powder

Placebo

PLACEBO COMPARATOR

Placebo Comparator (Placebo): Placebo drink consists of matched nutritional properties minus the polyphenols for BB powder.

Other: Placebo

Interventions

Wild blueberry powder DIETARY_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.

BB

Placebo OTHER

Placebo Comparator (Placebo): Placebo drink consists of matched nutritional properties minus the polyphenols for BB powder. Added to 6oz of pineapple juice.

Placebo

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University, Baton Rouge: lead
• Pennington Biomedical Research Center: collaborator
• Baton Rouge Neuromedical Center, The Spine Hospital of Louisiana: collaborator

Study Sites (3)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

The Baton Rouge Neuromedical Center, The Spine Hospital of Louisiana

Baton Rouge, Louisiana, 70810, United States

Location

Sensorimotor/Motor Control Lab, Louisiana State University

Baton Rouge, Louisiana, 80803, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jan M Hondzinski, PhD

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor was masked for the initial data analyses but unmasked for follow-up analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled-randomization by coin toss with stratification by group at the end of the study.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: August 31, 2018
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)