Clinical trial NCT02093130: Study of Pomegranate Juice on Memory in Older Adults
Official title: Twelve-Month, Double-blind, Placebo-Controlled Study of Pomegranate Juice in Normal Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impact of Pomegranate Juice on Memory in Older Adults
Keywords: Double-blind Trial
Placebo-controlled
Pomegranate
Memory
Memory Impairment
Cognition
Ages 50-75
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: POM Wonderful LLC
First posted: 2014-03-20
Enrollment: 212
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in cognitive testing results from Baseline to 1, 6, and 12 months
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between cognitive change and genotype
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Longevity Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Gary Small, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siddarth P, Thana-Udom K, Ojha R, Merrill D, Dzierzewski JM, Miller K, Small GW, Ercoli L. Sleep quality, neurocognitive performance, and memory self-appraisal in middle-aged and older adults with memory complaints. Int Psychogeriatr. 2021 Jul;33(7):703-713. doi: 10.1017/S1041610220003324. Epub 2020 Sep 28.
citation: Siddarth P, Li Z, Miller KJ, Ercoli LM, Merril DA, Henning SM, Heber D, Small GW. Randomized placebo-controlled study of the memory effects of pomegranate juice in middle-aged and older adults. Am J Clin Nutr. 2020 Jan 1;111(1):170-177. doi: 10.1093/ajcn/nqz241.