Clinical trial NCT02442804: Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke
Official title: The Effects of Pomegranate Polyphenols on Neuropsychological Functioning Following Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Pomegranate
Stroke
Neuropsychology
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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
* Pregnant
* 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)

Primary outcomes:
measure: Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
timeFrame: Baseline and Day 9
Secondary outcomes:
measure: Change From Baseline Mini-Mental State Examination - 2nd Edition Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Functional Independence Measure (FIM) Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Trail-making Test Part A Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Brief Test of Attention Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Controlled Oral Word Association Test Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Line Bisection Test Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Trail-making Test Part B Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Animals Fluency Score
timeFrame: Baseline and Day 9
measure: Change From Baseline Beck Depression Inventory - II (BDI-II) Score
timeFrame: Baseline and Day 9
measure: Change From Baseline State-Trait Anxiety Inventory - State Score
timeFrame: Baseline and Day 9
measure: Change From Baseline State-Trait Anxiety Inventory - Trait Score
timeFrame: Baseline and Day 9
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University East Campus Hospital
state: California
Study officials:
References: