【ChiCTR2200060234】Dietary interventions on constipation and gut outcomes for people with Parkinson’s disease
ChiCTR2200060234
尚未开始
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2022-05-23
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Parkinson's disease
Dietary interventions on constipation and gut outcomes for people with Parkinson’s disease
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
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.
随机平行对照
其它
Participants will be randomly assigned to experimental (MedDiet) or active control (high fibre diet) groups at a 1:1 ratio through a computer-based permuted block randomization, with random block sizes of 4-8. They will be informed of their assigned group by a person not involved in the assessments. The ran
All outcome assessors will be blinded to subject allocation.
N/A
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75
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2022-05-10
2026-12-31
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(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.；
请登录查看(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.；
请登录查看N/A
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