Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
    ARM 1: Kind: Experimental
    Label: Stroke - Placebo
    Description: Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 14 days
  • POMx Dietary Supplement
    Intervention Desc: Pomegranate supplement (1g) by mouth twice per day for 7 days
    ARM 1: Kind: Experimental
    Label: Stroke - POMx
    Description: Pomegranate supplement (1g) by mouth twice per day for 14 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score Baseline and Day 16 No
Secondary Change from Baseline Mini-Mental State Examination - 2nd Edition Score Baseline and Day 16 No
Secondary Test of Premorbid Functioning (TOPF) Score Day 1 No
Secondary Change from Baseline Trail-making Test Score Baseline and Day 16 No
Secondary Change from Baseline Brief Test of Attention Score Baseline and Day 16 No
Secondary Change from Baseline Controlled Oral Word Association Test Score Baseline and Day 16 No

Sponsors