The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Cognitive Measures
研究概览
简要总结
A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years of age and older
- •English speaking
- •Not living in a skilled or intermediate care level nursing facility
- •No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
- •A Mini-Mental State Exam (MMSE) score ≥ 23
排除标准
- •A cognitive deficit greater than that indicated according to the MMSE score
- •A clinical diagnosis of AD and/or related disorders
- •A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
- •Bleeding disorders
- •Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests
- •Gastrointestinal disorders causing impaired absorption of the study supplements
- •Insulin-dependent diabetes
- •Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure
- •Hematologic or oncologic disorders treated with chemotherapy in the previous two years
- •Active chemotherapy or radiation treatment for cancer
- •Current cigarette smoking
- •More than three major medical or psychiatric hospitalizations in the past year
- •Diagnosis of a terminal illness
- •A T score > 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)
- •A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)
- •Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an assessment visit
- •Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine, and Tacrine
- •Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants
- •Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial
- •Participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function
研究组 & 干预措施
OPC Synergy® and Catalyn
OPC Synergy® (100 mg/day of Grape Seed extract with 50 mg/day Green Tea extract (60% catechins)) and Catalyn® (1,248 IU/day of Vitamin D, 4,800 IU/day of Vitamin A, combined with vitamin C, thiamine, riboflavin, and vitamin B6)
干预措施: OPC Synergy® and Catalyn (Dietary Supplement)
Placebo
cellulose pills to simulate actual products
干预措施: Placebo (Dietary Supplement)
Ginkgo Synergy® and Choline
Ginkgo Synergy® (120 mg/day Ginkgo biloba leaf with 80 mg/day Ginkgo biloba whole extract combined with 40 mg/day Grape Seed extract) and Choline (700 mg choline/day)
干预措施: Ginkgo Synergy® and Choline (Dietary Supplement)
结局指标
主要结局
Cognitive Measures
时间窗: 6 months
The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)
次要结局
- Quality of Life Measures(6 months)
- Immune Function Markers(6 months)
研究者
John E. Lewis
Associate Professor
University of Miami