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Pomegranate Extract and Memory

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01950221
First Posted: September 25, 2013
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
POM Wonderful LLC
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles
September 16, 2013
September 25, 2013
June 16, 2017
October 2011
October 2015   (Final data collection date for primary outcome measure)
Improved cognitive performance [ Time Frame: 1 year ]
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.
Same as current
Complete list of historical versions of study NCT01950221 on ClinicalTrials.gov Archive Site
Cognitive performance improvement and genotype [ Time Frame: 1 year ]
Cognitive change in the pomegranate intervention group will vary according to genotype.
Same as current
Not Provided
Not Provided
 
Pomegranate Extract and Memory
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • Dietary Supplement: POMx
    "POMx" is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
  • Other: Placebo
  • Experimental: POMx
    POMx is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
    Intervention: Dietary Supplement: POMx
  • 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.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
October 2015
October 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01950221
11-002413
No
Not Provided
Not Provided
Gary Small, MD, University of California, Los Angeles
University of California, Los Angeles
POM Wonderful LLC
Not Provided
University of California, Los Angeles
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP