NCT03448055Unknown不适用
Nutritional Intervention With the Cysteine-rich Whey Protein Isolate Dietary Supplement Immunocal® in MCI Patients: Promotion of Brain Health & Wellness During Aging and Oxidative Stress
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in GSH levels in the brain
研究概览
简要总结
Alzheimer disease (AD) is a dementing illness characterized by progressive neuronal degeneration, gliosis, and the accumulation of intracellular inclusions and extracellular deposits of amyloid in discrete regions of the basal forebrain, hippocampus, and the association cortices. Mild cognitive impairment (MCI) refers to individuals with cognitive impairment (often memory loss) that fails to meet clinical criteria for AD or another dementing illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting diagnostic criteria for MCI:
- •Age 55-85
- •Male or female
- •Non-smoker
- •To ensure that the subject can physically fit in the scanner:
- •body weight ≤ 120 kg and
- •with a linear dimension max 55cm (shoulders or belly) Expected to remain in the greater Montreal area for the duration of study.
排除标准
- •Presence of an active, systemic illness (e.g., cancer, rheumatoid arthritis, etc.) or other chronic neurological (e.g. Parkinson's disease, multiple sclerosis) or psychiatric (e.g. major depression, schizophrenia) disease.
- •Subjects taking other experimental medications or psychotropic agents.
- •Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
- •Ambulatory subjects: As wheelchair-bound subjects present additional difficulties for transportation and MRI scanning.
- •Musculoskeletal abnormalities that preclude the ability of the subject to lie on his/her back for 1hr during MRI scanning.
- •Subjects who have a protein restricted diet as per their medical history.
- •Pregnancy
- •Subjects using N-acetylcysteine, α-lipoic acid supplements, other whey protein supplements or Vitamin C, within 2 months of enrolment and during the entire 6 months study period.
- •Allergies to milk proteins/ Milk protein intolerance
结局指标
主要结局
Change in GSH levels in the brain
时间窗: Baseline compared to month 6 (180 days)
Change in cerebral Glutathione levels of MCI patients measured by MRI/MRS scans
次要结局
- Change in plasma GSH:GSSG ratios measured by HPLC(Baseline compared to month 6 (180 days))
- Evaluation of neuropsychological and cognitive functions(Baseline compared to month 6 (180 days))
研究者
研究点 (2)
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