Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke

Stroke Clinical Trial

Official title:

The Effects of Pomegranate Polyphenols on Neuropsychological Functioning Following Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442804
• Other study ID #: 5150112
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2015
• Last updated: July 9, 2016
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether pomegranate supplements improve cognitive functioning following stroke.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Dietary Supplement:
• POMx
Pomegranate supplement (1g) by mouth twice per day for 7 days

Other:
• Placebo
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days

Locations

Country	Name	City	State
United States	Loma Linda University East Campus Hospital	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score	Composite neuropsychological measure	Baseline and Day 9	No
Secondary	Change from Baseline Mini-Mental State Examination - 2nd Edition Score	Neuropsychological screening measure	Baseline and Day 9	No
Secondary	Test of Premorbid Functioning (TOPF) Score	Neuropsychological measure of estimated intellectual ability	Day 1	No
Secondary	Change from Baseline Trail-making Test Score	Neuropsychological measure of executive functioning	Baseline and Day 9	No
Secondary	Change from Baseline Brief Test of Attention Score	Neuropsychological measure of attention	Baseline and Day 9	No
Secondary	Change from Baseline Controlled Oral Word Association Test Score	Neuropsychological measure of verbal fluency	Baseline and Day 9	No