John A Bellone1,2, Jeffrey R Murray2, Paolo Jorge3, Travis G Fogel4, Mary Kim3, Desiree R Wallace5, Richard E Hartman2. 1. Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University , Providence , RI , USA. 2. Department of Psychology, Loma Linda University (LLU) , Loma Linda , CA , USA. 3. Department of Physical Medicine and Rehabilitation, Loma Linda University (LLU) , Loma Linda , CA , USA. 4. Department of Neuropsychology, Loma Linda University (LLU) , Loma Linda , CA , USA. 5. Department of Pharmacy, Loma Linda University (LLU) , Loma Linda , CA , USA.
Abstract
Objectives: We tested whether supplementing with pomegranate polyphenols can enhance cognitive/functional recovery after stroke. Methods: In this parallel, block-randomized clinical trial, we administered commercially-available pomegranate polyphenol or placebo pills twice per day for one week to adult inpatients in a comprehensive rehabilitation setting starting approximately 2 weeks after stroke. Pills contained 1 g of polyphenols derived from whole pomegranate, equivalent to levels in approximately 8 oz of juice. Placebo pills were similar to the pomegranate pills except that they contained only lactose. Of the 163 patients that were screened, 22 were eligible and 16 were randomized (8 per group). We excluded one subject per group from the neuropsychological analyses since they were lost to follow-up, but we included all subjects in the analysis of functional data since outcome data were available. Clinicians and subjects were blinded to group assignment. Neuropsychological testing (primary outcome: Repeatable Battery for the Assessment of Neuropsychological Status) and functional independence scores were used to determine changes in cognitive and functional ability. Results: Pomegranate-treated subjects demonstrated more neuropsychological and functional improvement and spent less time in the hospital than placebo controls. Discussion: Pomegranate polyphenols enhanced cognitive and functional recovery after stroke, justifying pursuing larger clinical trials.
RCT Entities:
Objectives: We tested whether supplementing with pomegranatepolyphenols can enhance cognitive/functional recovery after stroke. Methods: In this parallel, block-randomized clinical trial, we administered commercially-available pomegranatepolyphenol or placebo pills twice per day for one week to adult inpatients in a comprehensive rehabilitation setting starting approximately 2 weeks after stroke. Pills contained 1 g of polyphenols derived from whole pomegranate, equivalent to levels in approximately 8 oz of juice. Placebo pills were similar to the pomegranate pills except that they contained only lactose. Of the 163 patients that were screened, 22 were eligible and 16 were randomized (8 per group). We excluded one subject per group from the neuropsychological analyses since they were lost to follow-up, but we included all subjects in the analysis of functional data since outcome data were available. Clinicians and subjects were blinded to group assignment. Neuropsychological testing (primary outcome: Repeatable Battery for the Assessment of Neuropsychological Status) and functional independence scores were used to determine changes in cognitive and functional ability. Results:Pomegranate-treated subjects demonstrated more neuropsychological and functional improvement and spent less time in the hospital than placebo controls. Discussion: Pomegranatepolyphenols enhanced cognitive and functional recovery after stroke, justifying pursuing larger clinical trials.
Authors: Marta Reyes-Corral; Noelia Sola-Idígora; Rocío de la Puerta; Joan Montaner; Patricia Ybot-González Journal: Int J Mol Sci Date: 2021-03-03 Impact factor: 5.923