Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pomegranate Extract and Memory

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
POM Wonderful LLC
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01950221
First received: September 16, 2013
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Dietary Supplement: POMx
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 12-Month, Double-blind, Placebo-Controlled Study of Pomegranate Extract

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Improved cognitive performance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cognitive performance improvement and genotype [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cognitive change in the pomegranate intervention group will vary according to genotype.


Estimated Enrollment: 212
Study Start Date: October 2011
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POMx
POMx is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
Dietary Supplement: POMx
"POMx" is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
Placebo Comparator: Placebo
Composition of the Drug Placebo Component/Function/Weight/Percentage of Fill Weight = Cellulose/Bulk agent/658 mg/64.5% Caramel/Colorant/79mg/7.8% Beet root/Flavor Ingredient/263mg/25.8% Magnesium stearate/USP Lubricant/10mg/1.0% Silica Dioxide/FCC Glidant/10mg/1.0% Total = 1020 mg/100% The method of manufacture of the placebo is identical to that of the drug product, except cellulose, caramel, and beet root are added in place of the active ingredient.
Other: Placebo

  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 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.
  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: NCT01950221

Locations
United States, California
UCLA Longevity Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
POM Wonderful LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Gary Small, MD, Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01950221     History of Changes
Other Study ID Numbers: 11-002413
Study First Received: September 16, 2013
Last Updated: November 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Double-blind Trial
Placebo-controlled
Pomegranate
Memory
Memory Impairment
Cognition
Ages 50-75

ClinicalTrials.gov processed this record on November 19, 2014