12-Month, Double-blind, Placebo-Controlled Study of Pomegranate Extract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Improved cognitive performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
POMx
POMx is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
干预措施: POMx (Dietary Supplement)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Improved cognitive performance
时间窗: 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.
次要结局
- Cognitive performance improvement and genotype(1 year)
研究者
Gary Small, MD
Professor of Psychiatry and Biobehavioral Sciences
University of California, Los Angeles