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Pomegranate Extract and Memory

NCT01950221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2020-03-02

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

POMx

"POMx" is a 1,000 milligram capsule of natural pomegranate polyphenol extract.

OTHER

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950221 on ClinicalTrials.gov