Twelve-Month Study of Pomegranate Extract in Normal Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by POM Wonderful LLC
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
POM Wonderful LLC
ClinicalTrials.gov Identifier:
NCT01571193
First received: April 2, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

In the present study, the investigators will examine and determine whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers. More specifically, the investigators 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.

    The investigators 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 (i.e., apolipoprotein E [APOE]).

Condition Intervention Phase
Non-demented
Dietary Supplement: Pomegranate extract
Dietary Supplement: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Twelve-Month, Double-blind, Placebo-Controlled Study of Pomegranate Extract in Normal Aging

Further study details as provided by POM Wonderful LLC:

Primary Outcome Measures:
  • improved cognitive performance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    improved cognitive performance compared to baseline versus those receiving a placebo after one, six, and twelve months.


Estimated Enrollment: 212
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active
Pomegranate extract
Dietary Supplement: Pomegranate extract
Pomegranate extract
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Placebo
Other Name: Placebo Comparator

Detailed Description:

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. We will draw additional blood for freezing and possible later assessment of inflammatory measures to explore whether pomegranate extract has effects on measures of inflammation. These samples will only be analyzed if we find that the extract shows cognitive benefits.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 amnestic Mild Cognitive Impairment will be included.
  • Age 50 to 75 years.
  • No significant cerebrovascular disease: modified Ischemic Score of < 4 (Rosen et al, 1980).
  • Adequate visual and auditory acuity to allow neuropsychological testing.
  • Screening laboratory tests and EKG without significant abnormalities that might interfere with 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, 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, diabetes, or cancer.
  • Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
  • 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, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or Warfarin. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
  • Use of more than one multivitamin per day. Vitamins other than the standard multivitamin supplement will not be allowed.
  • Use of cognitive enhancing supplements (e.g. Ginkgo biloba).
  • Use of any medications metabolized by 2C9 including: fluconazole, amiodarone, fenofibrate, fluvastatin, fluvoxamine, isoniazid, lovastatin, phenylbutazone, probenecid, sertraline, sulfamethoxazole, sulfaphenazole
  • teniposide, voriconazole, and zafirlukast.
  • Use of more than one daily baby aspirin (81mg) and/or use of any supplement containing pomegranate.
  • Use of any investigational drugs within the previous month or longer, depending on drug half-life.
  • Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571193

Contacts
Contact: Ali R Rejaei, MS 310-966-5800 arrejaei@pomwonderful.com

Locations
United States, California
Geriatric Psychiatry Division Semel Institute for Neuroscience & Human Behavior Recruiting
Los Angeles, California, United States, 90024
Contact: Gary W Small, MD    310-825-0291    gsmall@ucla.edu   
Principal Investigator: Gary W Small, MD         
Sponsors and Collaborators
POM Wonderful LLC
University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: POM Wonderful LLC
ClinicalTrials.gov Identifier: NCT01571193     History of Changes
Other Study ID Numbers: 11-002413
Study First Received: April 2, 2012
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014