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Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02442804
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
John Bellone, Loma Linda University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Dietary Supplement: POMx
Other: Placebo
Enrollment 16

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description Pomegranate supplement (1g) by mouth twice per day for 7 days Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Period Title: Overall Study
Started 8 8
Completed 7 7
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             0             1
Adverse Event             1             0
Arm/Group Title Stroke - POMx Stroke - Placebo Total
Hide Arm/Group Description Pomegranate supplement (1g) by mouth twice per day for 7 days Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
58.13  (13.62) 59.63  (13.48) 58.88  (13.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
2
  25.0%
3
  37.5%
5
  31.3%
Male
6
  75.0%
5
  62.5%
11
  68.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  12.5%
1
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  37.5%
1
  12.5%
4
  25.0%
White
4
  50.0%
5
  62.5%
9
  56.3%
More than one race
1
  12.5%
1
  12.5%
2
  12.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: standard score change
6.86  (6.52) 1.29  (6.65)
2.Secondary Outcome
Title Change From Baseline Mini-Mental State Examination - 2nd Edition Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: raw score
0.83  (2.48) 0.43  (2.64)
3.Secondary Outcome
Title Change From Baseline Functional Independence Measure (FIM) Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: raw score
22.63  (15.17) 7.25  (6.82)
4.Secondary Outcome
Title Change From Baseline Trail-making Test Part A Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: seconds
-18.14  (18.8) -19.86  (33.35)
5.Secondary Outcome
Title Change From Baseline Brief Test of Attention Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: raw score
3.29  (1.38) 0.14  (2.41)
6.Secondary Outcome
Title Change From Baseline Controlled Oral Word Association Test Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: number of acceptable words
1.29  (2.43) 2.14  (3.67)
7.Secondary Outcome
Title Change From Baseline Line Bisection Test Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: percentage of deviation from center
-0.91  (3.79) -3.71  (4.69)
8.Secondary Outcome
Title Change From Baseline Trail-making Test Part B Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: seconds
-20  (21.03) -39  (39.64)
9.Secondary Outcome
Title Change From Baseline Animals Fluency Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: number of acceptable words (animals)
-0.14  (2.19) 3.14  (2.67)
10.Secondary Outcome
Title Change From Baseline Beck Depression Inventory - II (BDI-II) Score
Hide Description 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
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: raw score
0.14  (9.58) -3.86  (9.48)
11.Secondary Outcome
Title Change From Baseline State-Trait Anxiety Inventory - State Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: raw score
-5.86  (10.43) -2.86  (12.62)
12.Secondary Outcome
Title Change From Baseline State-Trait Anxiety Inventory - Trait Score
Hide Description 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.
Time Frame Baseline and Day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description:
Pomegranate supplement (1g) by mouth twice per day for 7 days
Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: raw score
-1.57  (7.87) -1  (9.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stroke - POMx Stroke - Placebo
Hide Arm/Group Description Pomegranate supplement (1g) by mouth twice per day for 7 days Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
All-Cause Mortality
Stroke - POMx Stroke - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stroke - POMx Stroke - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stroke - POMx Stroke - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      0/8 (0.00%)    
Psychiatric disorders     
Psychotic Episode [1]  1/8 (12.50%)  1 0/8 (0.00%)  0
[1]
The participant experienced auditory hallucinations and a psychiatry consultant recommended withdrawal from the experiment. Notably, this subject began experiencing auditory hallucinations several days prior to POM administration.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John Bellone, Ph.D.
Organization: Brown University
Phone: 4012737100 ext 6168
Responsible Party: John Bellone, Loma Linda University
ClinicalTrials.gov Identifier: NCT02442804     History of Changes
Other Study ID Numbers: 5150112
First Submitted: May 7, 2015
First Posted: May 13, 2015
Results First Submitted: January 7, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017