ChiCTR2200060234尚未招募Unknown
Healing the gut: A randomized controlled trial on the effects and acceptability of Mediterranean diet (MedDiet) on constipation and gut microbiome in people with Parkinson’s disease
未提供1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年5月10日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of complete bowel movements
研究概览
简要总结
To investigate the effects and acceptability of Mediterranean diet versus high-fibre diet on constipation and gut outcomes in Chinese PD patients over the 8-week study period.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- All outcome assessors will be blinded to subject allocation.
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •(i) A diagnosis of idiopathic mild-to-moderate PD, as indicated by the Hoehn & Yahr Scale37 Stage I-III (presenting with mild-to-moderate unilateral/bilateral symptoms, some postural instability, physically independent); (ii) be aged ≥18 years; (iii) meet Rome III criteria for functional constipation38 (See Table 1 for the detailed diagnostic criteria); and (iv) be able to give written consent.
排除标准
- •(i) Those currently on specific diet prescription/ use of probiotics; (ii) use of antibiotics within 6 weeks before the start of the study; (iii) any inflammatory bowel disease/previous GI tract surgery; (iv) significant cognitive impairment indicated by an Abbreviated Mental Test score ≤6 (sensitivity: 96%; specificity: 94%)39; (v) history of laxative abuse; (vi) other contraindication that may limit full participation (e.g., severe dysphagia); and/or (vii) allergic to one or more of the following: nuts, fish or olive oil.
研究组 & 干预措施
2
High Fibre Diet
1
Mediterranean diet
结局指标
主要结局
Number of complete bowel movements
次要结局
- Gut microbiome composition
- Health related quality of life
- Dietary habits
- PD-related motor and non-motor symptoms
- Bowel movement
- Stool consistency
- Use of laxative
研究者
研究点 (1)
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