Phase 2
N=16
Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02442804 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score — 6.86; 1.29 standard score change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- POMx (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score |
6.86; 1.29 | — |
| SECONDARY Change From Baseline Mini-Mental State Examination - 2nd Edition Score |
0.83; 0.43 | — |
| SECONDARY Change From Baseline Functional Independence Measure (FIM) Score |
22.63; 7.25 | — |
| SECONDARY Change From Baseline Trail-making Test Part A Score |
-18.14; -19.86 | — |
| SECONDARY Change From Baseline Brief Test of Attention Score |
3.29; 0.14 | — |
| SECONDARY Change From Baseline Controlled Oral Word Association Test Score |
1.29; 2.14 | — |
| SECONDARY Change From Baseline Line Bisection Test Score |
-0.91; -3.71 | — |
| SECONDARY Change From Baseline Trail-making Test Part B Score |
-20; -39 | — |
| SECONDARY Change From Baseline Animals Fluency Score |
-0.14; 3.14 | — |
| SECONDARY Change From Baseline Beck Depression Inventory - II (BDI-II) Score |
0.14; -3.86 | — |
| SECONDARY Change From Baseline State-Trait Anxiety Inventory - State Score |
-5.86; -2.86 | — |
| SECONDARY Change From Baseline State-Trait Anxiety Inventory - Trait Score |
-1.57; -1 | — |
Summary
The purpose of this study is to determine whether pomegranate supplements improve cognitive functioning following stroke.
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)
Data sourced from ClinicalTrials.gov (NCT02442804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.