StrokePhase 2NCT02442804
Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke
A Phase 2 study testing POMx in people with Stroke, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether pomegranate supplements improve cognitive functioning following stroke. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stroke
- What is being tested?
- POMx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- Active renal disease
- Active liver disease
- Intracerebral hemorrhage in past 6 months
- Neurosurgery in past month
- Taking warfarin (Coumadin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University East Campus Hospital
Loma Linda, California, 25333 Barton Rd
About this study
Official title: The Effects of Pomegranate Polyphenols on Neuropsychological Functioning Following Ischemic Stroke
The purpose of this study is to determine whether pomegranate supplements improve cognitive functioning following stroke.
Read the 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
- Stroke
- Being tested
- POMx, Placebo
- Keywords
- Pomegranate, Stroke, Neuropsychology
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POMxDietary supplement
Pomegranate supplement (1g) by mouth twice per day for 7 days
PlaceboOther
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Stroke - POMx | Experimental | Pomegranate supplement (1g) by mouth twice per day for 7 days Receives: Dietary Supplement: POMx |
| Stroke - Placebo | Placebo comparator | Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 9
Secondary outcomes (11)
Change From Baseline Mini-Mental State Examination - 2nd Edition Score
The MMSE-2 is a brief (about 10 minutes) screening tool that touches upon orientation to time and place, recall, attention/calculation, naming, repetition, comprehension, reading, writing, and drawing, with all the scores from these domains cumulating to a maximum of 30 points (minimum = 0). Higher score indicates better performance.
Measured: Baseline and Day 9
Change From Baseline Functional Independence Measure (FIM) Score
Functional Independence Measure (FIM) Score consists of eighteen sub-measures under the following 6 categories: Self-Care (eating, grooming, bathing, dressing upper body, dressing lower body, toileting), Sphincter Control (bladder control, bowel control), Transfers (bed/chair/wheelchair transfer, toilet transfer, tub/shower transfer), Locomotion (walk/wheelchair, stairs), Communication (comprehension, expression), and Social Cognition (social interaction, memory, problem solving). Scores for each sub-measure range from 1 (total assistance) to 7 (complete independence), and the 18 scores are summed to obtain the FIM score. Higher scores indicate better performance.
Measured: Baseline and Day 9
Change From Baseline Trail-making Test Part A Score
The Trail-making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Results for the test are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.
Measured: Baseline and Day 9
Change From Baseline Brief Test of Attention Score
On the Brief Test of Attention (BTA), the examinee listens to a string of numbers and letters and must mentally tally (without the use of their fingers) how many numbers are in a particular trial. They do this for 10 trials and then are given 10 additional trials with the task of tallying how many letters they hear. The task increases in difficulty as the trials progress, and the entire test takes 5-10 minutes to complete. The scorer adds the number of trials correct from all 20 trials to attain a total score (ranges from 0 to 20). Higher scores indicate better performance.
Measured: Baseline and Day 9
Change From Baseline Controlled Oral Word Association Test Score
The Controlled Oral Word Association Test (COWAT) is a measure of controlled verbal fluency that involves the examinee naming as many words that begin with a certain letter of the alphabet as he or she can in 1 minute. There are a few rules (i.e., no proper nouns and no words that have the same meaning and only differ by its suffix) and the task is repeated twice more with different letters each time. The scorer tallies the total acceptable words from all 3 trials into one total score (ranges from 0 on up). Higher total score indicates better performance.
Measured: Baseline and Day 9
Change From Baseline Line Bisection Test Score
The Line Bisection Test consists of 20 horizontal lines of varying length and proximity to the center of a sheet of paper (i.e., some are closer to the left or right sides of the page). The examinee is asked to place a mark to bisect each line. The scorer measures the degree of deviation from the center of each line (in cm) and attains the absolute value of the average percentage of deviation across all 20 lines. The scorer also attains the dominant direction of deviation (i.e., whether the examinee misses more to the left or to the right on average across the 20 lines). The value of the largest deviation is imputed for any omissions. Percentage ranges from 0 on up. Higher percentage of deviation indicates worse performance.
Measured: Baseline and Day 9
Change From Baseline Trail-making Test Part B Score
The Trail-making Test Part B consists of circles with either numbers (1 - 13) or letters (A - L) in them; as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.
Measured: Baseline and Day 9
Change From Baseline Animals Fluency Score
The Animal Fluency task involves providing the examinee a category prompt. For example, the examiner asks the examinee to name as many animals as he or she can in 1 minute. The total number of acceptable words is tallied for a total score (ranging from 0 on up). Higher scores indicate better performance.
Measured: Baseline and Day 9
Change From Baseline Beck Depression Inventory - II (BDI-II) Score
The Beck Depression Inventory - Second Edition (BDI-II) is a widely used self-report questionnaire of depressive symptoms. The examinee is asked to respond to 21 items by endorsing whether or not they experience symptoms of sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentrating difficulty, tiredness or fatigue, and loss of interest in sex. Examinees can also describe the degree of severity of each symptom, as each item ranges from 0-3. The scorer adds the scores for each item to attain a total score, which is interpreted according to the following guidelines: 0-13 = minimal depression, 14-19 = mild depression, 20-28 = moderate depression, 29-63 = severe depression
Measured: Baseline and Day 9
Change From Baseline State-Trait Anxiety Inventory - State Score
The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee's general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from "not at all" to "very much so." Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms.
Measured: Baseline and Day 9
Change From Baseline State-Trait Anxiety Inventory - Trait Score
The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee's general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from "not at all" to "very much so." Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms.
Measured: Baseline and Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Bellone, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442804
- Sponsor's protocol ID
- 5150112
- Status last verified
- Apr 2017
- First submitted
- 7 May 2015
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pomegranate Polyphenols on Neuropsychological Functioning Following Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02442804
- Acronym / sponsor ID
- 5150112
- Conditions
- Stroke
- Keywords
- Pomegranate, Stroke, Neuropsychology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke - POMx | Experimental | Dietary Supplement: POMxPomegranate supplement (1g) by mouth twice per day for 7 days |
| Stroke - Placebo | Placebo comparator | Other: PlaceboPlacebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Less than 6 years of education
- Global aphasia
- Pregnant
- History of allergy to pomegranates
- History of traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POMxPomegranate supplement (1g) by mouth twice per day for 7 days | Dietary supplement | Stroke - POMx |
| PlaceboPlacebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days | Other | Stroke - Placebo |
Primary outcome
Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Time frame: Baseline and Day 9
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.
11 secondary outcomes
Change From Baseline Mini-Mental State Examination - 2nd Edition Score
Time frame: Baseline and Day 9
Change From Baseline Functional Independence Measure (FIM) Score
Time frame: Baseline and Day 9
Change From Baseline Trail-making Test Part A Score
Time frame: Baseline and Day 9
Change From Baseline Brief Test of Attention Score
Time frame: Baseline and Day 9
Change From Baseline Controlled Oral Word Association Test Score
Time frame: Baseline and Day 9
Change From Baseline Line Bisection Test Score
Time frame: Baseline and Day 9
Change From Baseline Trail-making Test Part B Score
Time frame: Baseline and Day 9
Change From Baseline Animals Fluency Score
Time frame: Baseline and Day 9
Change From Baseline Beck Depression Inventory - II (BDI-II) Score
Time frame: Baseline and Day 9
Change From Baseline State-Trait Anxiety Inventory - State Score
Time frame: Baseline and Day 9
Change From Baseline State-Trait Anxiety Inventory - Trait Score
Time frame: Baseline and Day 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing POMx in people with Stroke, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score (time frame: Baseline and Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.