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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Stroke - POMx 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

Participant Flow:   Overall Study
    Stroke - POMx   Stroke - Placebo
STARTED   8   8 
COMPLETED   7   7 
NOT COMPLETED   1   1 
Withdrawal by Subject                0                1 
Adverse Event                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stroke - POMx 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
Total Total of all reporting groups

Baseline Measures
   Stroke - POMx   Stroke - Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.13  (13.62)   59.63  (13.48)   58.88  (13.11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  25.0%      3  37.5%      5  31.3% 
Male      6  75.0%      5  62.5%      11  68.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   8   8   16 


  Outcome Measures

1.  Primary:   Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score   [ Time Frame: Baseline and Day 9 ]

2.  Secondary:   Change From Baseline Mini-Mental State Examination - 2nd Edition Score   [ Time Frame: Baseline and Day 9 ]

3.  Secondary:   Change From Baseline Functional Independence Measure (FIM) Score   [ Time Frame: Baseline and Day 9 ]

4.  Secondary:   Change From Baseline Trail-making Test Part A Score   [ Time Frame: Baseline and Day 9 ]

5.  Secondary:   Change From Baseline Brief Test of Attention Score   [ Time Frame: Baseline and Day 9 ]

6.  Secondary:   Change From Baseline Controlled Oral Word Association Test Score   [ Time Frame: Baseline and Day 9 ]

7.  Secondary:   Change From Baseline Line Bisection Test Score   [ Time Frame: Baseline and Day 9 ]

8.  Secondary:   Change From Baseline Trail-making Test Part B Score   [ Time Frame: Baseline and Day 9 ]

9.  Secondary:   Change From Baseline Animals Fluency Score   [ Time Frame: Baseline and Day 9 ]

10.  Secondary:   Change From Baseline Beck Depression Inventory - II (BDI-II) Score   [ Time Frame: Baseline and Day 9 ]

11.  Secondary:   Change From Baseline State-Trait Anxiety Inventory - State Score   [ Time Frame: Baseline and Day 9 ]

12.  Secondary:   Change From Baseline State-Trait Anxiety Inventory - Trait Score   [ Time Frame: Baseline and Day 9 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: john_bellone@brown.edu



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