Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke

Loma Linda University (LLU)

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Dietary Supplement: POMx; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02442804

5150112

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

16 participants in 2 patient groups, including a placebo group

Stroke - POMx

Experimental group

Description:

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

Treatment:

Dietary Supplement: POMx

Stroke - Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo