Study of Pomegranate Juice on Memory in Older Adults
This project is designed to study whether pomegranate juice benefits cognitive abilities in middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of two treatment groups: either a placebo or the pomegranate juice. Subjects will drink eight ounces of the pomegranate juice or placebo daily for twelve months.
The investigators expect the people receiving the pomegranate juice to show better cognitive performance compared with those receiving a placebo after one, six, and twelve months. The investigators believe cognitive decline and treatment response will vary according to a genetic risk for Alzheimer's.
The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints.
Subsequently, subjects will undergo the first memory (or neuropsychological) assessments. Following the first assessment, subjects will begin drinking the juice (either the pomegranate juice or the placebo). Subjects will undergo a brief memory test at one-month mark. At six months, subjects will have a second, full neuropsychological assessment. The final assessment will take place at the end of the study, the 12-month mark. Additional blood will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if outcomes are positive.
In total, subjects will be expected to come to the University of California, Los Angeles (UCLA) for 5 visits during the course of 12-13 months.
|Impact of Pomegranate Juice on Memory in Older Adults||Dietary Supplement: Pomegranate Juice Dietary Supplement: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Twelve-Month, Double-blind, Placebo-Controlled Study of Pomegranate Juice in Normal Aging|
- Change in cognitive testing results from Baseline to 1, 6, and 12 months [ Time Frame: 1 year ]Non-demented volunteers aged 50-75 who receive a daily dietary supplement of pomegranate juice will show improved cognitive performance compared to baseline versus those receiving a placebo after one, six, and twelve months.
- Correlation between cognitive change and genotype [ Time Frame: 1 year ]Cognitive change in the pomegranate intervention group will vary according to genotypes found to influence age at dementia onset (e.g., apolipoprotein E [APOE] TOMM40).
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Pomegranate Juice
Eight ounces of 100% Pomegranate Juice daily
|Dietary Supplement: Pomegranate Juice|
Placebo Comparator: Placebo
Eight ounces of Placebo juice daily. The Placebo is engineered to look and taste the same as the Pomegranate Juice and contains the same vitamins and minerals as the Pomegranate Juice. Because the Placebo juice does not come from actual pomegranates, it does not contain the polyphenols contained in the Pomegranate Juice.
|Dietary Supplement: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02093130
|Contact: Anya Rosensteelfirstname.lastname@example.org|
|United States, California|
|UCLA Longevity Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Anya Rosensteel 310-825-0545 email@example.com|
|Principal Investigator: Gary Small, MD|
|Principal Investigator:||Gary Small, MD||University of California, Los Angeles|