Pomegranate Extract and Memory
This project is designed to study whether pomegranate extract 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 extract supplement. Both the placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain blindness. Subjects will take one 1000 milligram capsule daily for twelve months.
The investigators expect the people receiving the pomegranate extract supplement 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 taking the supplement (either the pomegranate extract 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. Subjects will also be asked to come to the University of California, Los Angeles (UCLA) at 3 and 9 months for supplement refills.
In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13 months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||12-Month, Double-blind, Placebo-Controlled Study of Pomegranate Extract|
- Improved cognitive performance [ Time Frame: 1 year ] [ Designated as safety issue: No ]Non-demented volunteers aged 50-75 who receive a daily dietary supplement of pomegranate extract will show improved cognitive performance compared to baseline versus those receiving a placebo after one, six, and twelve months.
- Cognitive performance improvement and genotype [ Time Frame: 1 year ] [ Designated as safety issue: No ]Cognitive change in the pomegranate intervention group will vary according to genotype.
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
POMx is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
Dietary Supplement: POMx
"POMx" is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
Placebo Comparator: Placebo
Composition of the Drug Placebo Component/Function/Weight/Percentage of Fill Weight = Cellulose/Bulk agent/658 mg/64.5% Caramel/Colorant/79mg/7.8% Beet root/Flavor Ingredient/263mg/25.8% Magnesium stearate/USP Lubricant/10mg/1.0% Silica Dioxide/FCC Glidant/10mg/1.0% Total = 1020 mg/100% The method of manufacture of the placebo is identical to that of the drug product, except cellulose, caramel, and beet root are added in place of the active ingredient.
|Contact: Jacqueline Martinez, M.S.||firstname.lastname@example.org|
|Contact: Natacha Donoghueemail@example.com|
|United States, California|
|UCLA Longevity Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Jackie Martinez, MS 310-206-1319 firstname.lastname@example.org|
|Principal Investigator: Gary Small, MD|