Expired Study
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Loma Linda, California


Purpose:

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


Study summary:

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.


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)


Study is Available At:


Original ID:

5150112


NCT ID:

NCT02442804


Secondary ID:


Study Acronym:


Brief Title:

Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke


Official Title:

The Effects of Pomegranate Polyphenols on Neuropsychological Functioning Following Ischemic Stroke


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Loma Linda University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Study Dates

Start Date:June 2015
Completion Date:April 2016
Completion Type:Actual
Primary Completion Date:April 2016
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 9, 2016
First Received Date:May 7, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from Baseline Controlled Oral Word Association Test Score
Time Frame:Baseline and Day 9
Safety Issues:False
Description:Neuropsychological measure of verbal fluency
Outcome Type:Secondary Outcome
Measure:Change from Baseline Brief Test of Attention Score
Time Frame:Baseline and Day 9
Safety Issues:False
Description:Neuropsychological measure of attention
Outcome Type:Secondary Outcome
Measure:Change from Baseline Trail-making Test Score
Time Frame:Baseline and Day 9
Safety Issues:False
Description:Neuropsychological measure of executive functioning
Outcome Type:Secondary Outcome
Measure:Test of Premorbid Functioning (TOPF) Score
Time Frame:Day 1
Safety Issues:False
Description:Neuropsychological measure of estimated intellectual ability
Outcome Type:Secondary Outcome
Measure:Change from Baseline Mini-Mental State Examination - 2nd Edition Score
Time Frame:Baseline and Day 9
Safety Issues:False
Description:Neuropsychological screening measure
Outcome Type:Primary Outcome
Measure:Change from Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Time Frame:Baseline and Day 9
Safety Issues:False
Description:Composite neuropsychological measure

Study Interventions

Intervention Type:Dietary Supplement
Name:POMx
Description:Pomegranate supplement (1g) by mouth twice per day for 7 days
Arm Name:Stroke - POMx
Intervention Type:Other
Name:Placebo
Description:Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Arm Name:Stroke - Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Stroke - Placebo
Description:Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Study Arm Type:Experimental
Arm Name:Stroke - POMx
Description:Pomegranate supplement (1g) by mouth twice per day for 7 days

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Loma Linda University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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