Pomegranate Extract and Memory
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 10/18/2018 |
| Start Date: | October 2011 |
| End Date: | October 2015 |
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.
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.
Inclusion Criteria:
- Agreement to participate in the 12-month double-blind, placebo-controlled clinical
trial of pomegranate extract.
- Nondemented subjects either those with normal cognition or with Mild Cognitive
Impairment will be included.
- Age 50 to 75 years.
- No significant cerebrovascular disease: modified Ischemic Score of < 4
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Screening laboratory tests and EKG without significant abnormalities that might
interfere with the study. If screening laboratory tests or EKG show abnormalities,
subject must obtain written clearance from primary care physician before continuing in
the study.
Exclusion Criteria:
- Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular,
Lewy body, frontotemporal) (McKhann et al, 1984). Evidence of other neurological or
physical illness that can produce cognitive deterioration. Volunteers with a history
of stroke, Transient Ischemic Attack (TIA), carotid bruits, or lacunes on MRI scans
will be excluded. Determination of dementia will be based on the clinical evaluation
including assessment of functional abilities, and cognitive screening.
- Contraindication to the MRI including claustrophobia, metal in body, surgery within 60
days, certain implants or previous abnormal MRI results.
- Evidence of Parkinson's disease as determined by the motor examination (items 18-31)
of the Unified Parkinson's Disease Rating Scale (Fahn et al, 1987).
- History of myocardial infarction within the previous year, or unstable cardiac
disease.
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100).
- History of significant liver disease, clinically-significant pulmonary disease, or
diabetes.
- Current diagnosis of any major psychiatric disorder
- Current diagnosis or history of alcoholism or substance addiction.
- Regular use of any medication that may affect cognitive functioning including:
centrally active beta-blockers, narcotics, Clonidine, anti-Parkinsonian medications,
antipsychotics, systemic corticosteroids, medications with significant cholinergic or
anticholinergic effects, anti-convulsants, or Warfarin.
- Occasional use of anxiety or sleeping medications known to cause cognitive dulling
will be allowed, but discouraged: chloral hydrate, non-benzodiazepine hypnotics such
as: Ambien (Zolpidem) and Lunesta; or benzodiazepines such as Ativan (Lorazepam),
Xanax (Alprazolam), Klonopin (Clonazepam), and Restoril (Temazepam).
- Use of any of the following medications: Amitriptyline, Amiodarone, Desipramine,
Fenofibrate, Flecainide, Fluconazole, Fluoxetine, Fluvastatin, Fluvoxamine, Isoniazid,
Lovastatin, Ondansetron, Phenylbutazone, Probenecid, Sertraline, Sulfamethoxazole,
Sulfaphenazole, Teniposide, Voriconazole, Warfarin, and Zafirlukast
- Use of cognitive enhancing supplements (e.g. Ginkgo biloba).
- Use of any supplement containing pomegranate or pomegranate juice.
- Use of any investigational drugs within the previous month or longer, depending on
drug half-life.
- Pregnancy.
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