Study

Pomegranate Extract and Memory- Los Angeles

Eligibility Requirements:

VOLUNTEERS MUST BE:
• In Good Health
• Ages 50-75
• MRI Eligible: Not having metal or medically implanted devices in the body
• Willing to Avoid Pomegranate

HAVE NO HISTORY OF:
• Substance Abuse
• Psychiatric Conditions: ADHD,Schizophrenia, Bipolar Disorder, or Depression
• Heart Attack or Stroke
• Liver, Pulmonary Disease or Diabetes
• Neurodegenerative Disease or Dementia
• Epilepsy
• Cataract Surgery

EXCLUDED MEDICATIONS:
• Statins to reduce Cholesterol: Crestor, Zocor or Lipitor
• Certain Antidepressants: Zoloft, Prozac, or Elavil
• Cognitive-enhancing Supplements: Ginkgo-Biloba, Resveratrol or Curcumin

OTHER CRITERIA:
• Subjects must be proficient in English
• Subjects must not be enrolled in another clinical trial

About the Study:

The present study seeks to determine whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers.  Researchers aim to test long-term effects of pomegranate extract at 6 months and 12 months.  To test the primary hypothesis, up to 212 non-demented subjects will be enrolled. Subjects will be randomized, using a double-blind design, to one of two treatment groups: supplement (1,000 mg pomegranate extract per day) or placebo, and followed for 12 months. Neuropsychological assessments will determine cognitive change, and be repeated at 1, 6 and 12 months. All subjects will receive a baseline assessment (clinical examination, MRI scan, and screening laboratory tests) in order to exclude volunteers with dementia or other conditions that might influence results.

Purpose:

The purpose of this study is to find out determine whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers.  More specifically, researchers will test the following primary hypothesis:

1. 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.

Researchers will also explore the following secondary hypothesis:

2. Cognitive change in the pomegranate intervention group will vary according to genotypes found to influence age-related cognitive decline.

What is Involved:

This study involves the following:
1. Screening to determine your eligibility to participate in the study;
2. Medical evaluation to measure your physical condition;
3. Blood draws to test for genetic markers of Alzheimer’s disease and inflammatory markers;
4. Magnetic Resonance Imaging (MRI) to help investigators better understand the relationship between the structure of the brain and how it works and to rule out other health conditions;
5. Four Neuropsychological assessments to measure your mental condition over the course of 12 months.
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Age:
50 to 75
Duration:
Visits:
Study Type:
Prevention Studies; Studies for People without Memory Impairment

Study Site Locations: