Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Bowel habits
研究概览
简要总结
The investigators will investigate the effects of an 8-week resistant starch (RS) supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:
- symptoms of constipation (assessed by clinical scores);
- fecal short chain fatty acid concentrations (measured by chromatography);
- gut microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Written informed to participate
- •For patients: diagnosis of Parkinson Disease
排除标准
- •Use of antibiotics, steroids or probiotic supplements
- •Chronic or acute disorders of the gastrointestinal tract
- •History of gastrointestinal surgery (other than appendectomy)
- •For healthy controls: Family history of neurodegenerative disorders
研究组 & 干预措施
RS
Resistant starch supplementation (5 g twice a day)
干预措施: Resistant starch (Dietary Supplement)
No RS
PD patients who do not receive resistant starch, but who receive recommendations concerning healthy Nutrition (based on the guidelines of the German Society for Nutrition)
干预措施: Recommendation with regard to nutrition (Other)
结局指标
主要结局
Bowel habits
时间窗: 8 weeks
Number of patients with improved bowel habits
Fecal short chain fatty acid (SCFA) concentrations
时间窗: 8 weeks
Number of patients with either a) increased, b.) unaltered or c) decreased concentration of short chain fatty acids in fecal samples at 8 weeks (compared to baseline)
Analysis of fecal microbiota composition
时间窗: 8 weeks
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
次要结局
未报告次要终点
研究者
Dr. Marcus Unger
PD Dr.
Universität des Saarlandes