Study of Pomegranate Juice on Memory in Older Adults

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT02093130

Collaborator

POM Wonderful LLC (Industry)

212

Enrollment

Location

Arms

51.9

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project is designed to study whether pomegranate juice 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 juice. Subjects will drink eight ounces of the pomegranate juice or placebo daily for twelve months.

The investigators expect the people receiving the pomegranate juice 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 drinking the juice (either the pomegranate juice 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.

In total, subjects will be expected to come to the University of California, Los Angeles (UCLA) for 5 visits during the course of 12-13 months.

Condition or Disease	Intervention/Treatment	Phase
Impact of Pomegranate Juice on Memory in Older Adults	Dietary Supplement: Pomegranate Juice Dietary Supplement: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Twelve-Month, Double-blind, Placebo-Controlled Study of Pomegranate Juice in Normal Aging

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pomegranate Juice Eight ounces of 100% Pomegranate Juice daily	Dietary Supplement: Pomegranate Juice
Placebo Comparator: Placebo Eight ounces of Placebo juice daily. The Placebo is engineered to look and taste the same as the Pomegranate Juice and contains the same vitamins and minerals as the Pomegranate Juice. Because the Placebo juice does not come from actual pomegranates, it does not contain the polyphenols contained in the Pomegranate Juice.	Dietary Supplement: Placebo

Arm

Intervention/Treatment

Experimental: Pomegranate Juice

Eight ounces of 100% Pomegranate Juice daily

Dietary Supplement: Pomegranate Juice

Placebo Comparator: Placebo

Eight ounces of Placebo juice daily. The Placebo is engineered to look and taste the same as the Pomegranate Juice and contains the same vitamins and minerals as the Pomegranate Juice. Because the Placebo juice does not come from actual pomegranates, it does not contain the polyphenols contained in the Pomegranate Juice.

Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

Change in cognitive testing results from Baseline to 1, 6, and 12 months [1 year]
Non-demented volunteers aged 50-75 who receive a daily dietary supplement of pomegranate juice will show improved cognitive performance compared to baseline versus those receiving a placebo after one, six, and twelve months.

Secondary Outcome Measures

Correlation between cognitive change and genotype [1 year]
Cognitive change in the pomegranate intervention group will vary according to genotypes found to influence age at dementia onset (e.g., apolipoprotein E [APOE] TOMM40).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.