Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke

NCT ID: NCT02442804

Last Updated: 2017-08-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Stroke - POMx

Pomegranate supplement (1g) by mouth twice per day for 7 days

Group Type EXPERIMENTAL

POMx

Intervention Type DIETARY_SUPPLEMENT

Pomegranate supplement (1g) by mouth twice per day for 7 days

Stroke - Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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POMx

Pomegranate supplement (1g) by mouth twice per day for 7 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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John Bellone

MA

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loma Linda University East Campus Hospital

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5150112

Identifier Type: -

Identifier Source: org_study_id

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