The Effects of Pomegranate Polyphenols on Neuropsychological Functioning Following Ischemic Stroke
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Study Overview
Brief Summary
The purpose of this study is to determine whether pomegranate supplements improve cognitive functioning following stroke.
Detailed Description
Research suggests that antioxidants (substances that may slow or prevent cell damage) found in many fruits and vegetables may help improve brain functioning (for example, memory and attention) in healthy individuals and prevent cognitive decline in individuals who have suffered a stroke. The purpose of this research study is to examine whether dietary supplementation with an antioxidant extract can help promote healthy cognitive functioning as a component of recovery after stroke. The procedures include: Administering polyphenols via 2 POMx pills, each of which contains polyphenols derived from pomegranates equivalent to the content of approximately 8 ounces of pomegranate juice, or placebo pills (capsules containing no polyphenol ingredients), every day for one week to inpatients who are in the acute post-stroke phase. Neuropsychological testing pre- and post-treatment will determine whether cognitive functioning changes. Subjects will be randomized into either a placebo or polyphenol group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suffered an ischemic stroke and admitted to LLUMC Rehabilitation Institute for inpatient care
- •Fluent in English
- •Between the age of 18 and 89 years old
Exclusion Criteria
- •Less than 6 years of education
- •Global aphasia
- •History of allergy to pomegranates
- •History of traumatic brain injury
- •Neurodegenerative disease or neurologic condition with known cognitive impact (e.g., Alzheimer's disease)
- •Active renal disease
- •Active liver disease
- •Intracerebral hemorrhage in past 6 months
- •Neurosurgery in past month
- •Taking warfarin (Coumadin)
Arms & Interventions
Stroke - POMx
Pomegranate supplement (1g) by mouth twice per day for 7 days
Intervention: POMx (Dietary Supplement)
Stroke - Placebo
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Time Frame: Baseline and Day 9
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) provides both a total scale score and scores for 5 different cognitive domains. It is relatively brief (approximately 20 minutes total) and has alternate forms. Specifically, the test measures immediate memory (with list learning and story memory), visuospatial/constructional ability (with figure copy and line orientation), language (with picture naming and semantic fluency), attention (with digit span and coding), and delayed memory (with list recall, list recognition, story recall, and figure recall). Scores from all subtests are aggregated into a total composite score (manual provides conversion procedure). RBANS data were age-normed based on the sample described in the manual (Randolph, 2012) and were analyzed as index scores (also referred to as standard scores), which have a mean of 100 and a standard deviation of 15. Higher scores on each sub measure and index indicate better performance.
Secondary Outcomes
- Change From Baseline Functional Independence Measure (FIM) Score(Baseline and Day 9)
- Change From Baseline Brief Test of Attention Score(Baseline and Day 9)
- Change From Baseline Line Bisection Test Score(Baseline and Day 9)
- Change From Baseline Mini-Mental State Examination - 2nd Edition Score(Baseline and Day 9)
- Change From Baseline Trail-making Test Part B Score(Baseline and Day 9)
- Change From Baseline Trail-making Test Part A Score(Baseline and Day 9)
- Change From Baseline Controlled Oral Word Association Test Score(Baseline and Day 9)
- Change From Baseline Animals Fluency Score(Baseline and Day 9)
- Change From Baseline State-Trait Anxiety Inventory - Trait Score(Baseline and Day 9)
- Change From Baseline Beck Depression Inventory - II (BDI-II) Score(Baseline and Day 9)
- Change From Baseline State-Trait Anxiety Inventory - State Score(Baseline and Day 9)
Investigators
John Bellone
MA
Loma Linda University