Healthy Volunteers Clinical Trial
Official title:
12-Month, Double-blind, Placebo-Controlled Study of Pomegranate Extract
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.
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