Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke

NCT02442804 | Completed Phase 2 Results

• 1 other identifier: 5150112
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Pomegranate; Stroke; Neuropsychology

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score

  The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) provides both a total scale score and scores for 5 different cognitive domains. It is relatively brief (approximately 20 minutes total) and has alternate forms. Specifically, the test measures immediate memory (with list learning and story memory), visuospatial/constructional ability (with figure copy and line orientation), language (with picture naming and semantic fluency), attention (with digit span and coding), and delayed memory (with list recall, list recognition, story recall, and figure recall). Scores from all subtests are aggregated into a total composite score (manual provides conversion procedure). RBANS data were age-normed based on the sample described in the manual (Randolph, 2012) and were analyzed as index scores (also referred to as standard scores), which have a mean of 100 and a standard deviation of 15. Higher scores on each sub measure and index indicate better performance.

  Baseline and Day 9

Secondary Outcomes (11)

• Change From Baseline Mini-Mental State Examination - 2nd Edition Score

  Baseline and Day 9

• Change From Baseline Functional Independence Measure (FIM) Score

  Baseline and Day 9

• Change From Baseline Trail-making Test Part A Score

  Baseline and Day 9

• Change From Baseline Brief Test of Attention Score

  Baseline and Day 9

• Change From Baseline Controlled Oral Word Association Test Score

  Baseline and Day 9

Study Arms (2)

Stroke - POMx

EXPERIMENTAL

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

Dietary Supplement: POMx

Stroke - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

POMx DIETARY_SUPPLEMENT

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

Stroke - POMx

Placebo OTHER

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

Stroke - Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University East Campus Hospital

Loma Linda, California, 25333 Barton Rd, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: John Bellone, Ph.D.
• Organization: Brown University

john_bellone@brown.edu

4012737100

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MA

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 13, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 2, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-04

Locations

US (1)