NCT01662414已完成4 期
Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain Function
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
研究概览
简要总结
This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.
The principal objective is to evaluate the changes in biomarkers of oxidative stress and,plasma amino acids, as well as improvement of clinical symptoms and brain function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Idiopathic Parkinson's Disease
- •Subjects who are willing and able to participate in the trial and has provided written, informed consent.
排除标准
- •Subjects who are allergic to Whey protein (HMS 90®).
- •Subjects who are treated with chemotherapy .
- •Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease.
- •Subjects with history of diabetes. 4.
- •Subjects with abnormal liver function test
研究组 & 干预措施
Placebo (Soy protein)
Placebo Comparator
干预措施: Soy protein (Dietary Supplement)
HMS 90®
Active Comparator
干预措施: Whey protein (Dietary Supplement)
结局指标
主要结局
Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
时间窗: 6 months
Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
时间窗: 6 months
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24(6 months)
- • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24(6 months)
- Nutrition Questionnaire score change baseline to week 24(6 months)
- Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24(6 months)
- • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24(6 months)
- • Parkinson's Disease quality of life questionnaire score change from baseline to week 24(6 months)
研究者
研究点 (1)
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