Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Change in weekly bowel movement frequency
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate whether a dietitian-guided nutritional intervention can improve constipation symptoms in people with Parkinson's disease (PD). The main questions it aims to answer are:
- Can a dietitian-guided nutritional intervention increase the number of weekly bowel movements in individuals with PD and functional constipation?
- Can this intervention positively influence gut microbiota composition, dietary intake, and nutritional status?
Researchers will compare the intervention group to a control group that will receive general dietary guidance only after the study period, to see if the intervention leads to improvements in bowel function and related health outcomes.
Participants will:
- Follow a diet plan developed by a dietitian, based on dietary reference intakes and tailored to the needs of individuals with PD and constipation
- Participate in follow-up sessions with the dietitian for 3 months
- Complete assessments at baseline, midpoint, and end of the intervention to evaluate bowel function, constipation symptoms, gut microbiota, nutritional status, and diet quality
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults with a previous diagnosis of Parkinson's disease
- •On a stable dose of levodopa for at least 3 months
- •Diagnosis of Functional Constipation by the Rome IV protocol
Exclusion Criteria
- •Diagnosis of atypical or secondary parkinsonism
- •Hoehn and Yahr stage greater than 2
- •Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures
- •Previous diagnosis of dementia
- •Presence of comorbidities such as active cancer, chronic obstructive pulmonary disease (COPD), heart failure, and/or chronic kidney disease
- •History of gastrointestinal cancers, inflammatory bowel diseases, or surgeries involving the gastrointestinal tract
- •Constipation secondary to clinical conditions such as hypothyroidism or diabetes mellitus
- •Use of opioids
- •Use of probiotics or antibiotics in the past 8 weeks
- •Continuous use of laxatives in the past 8 weeks
- •Presence of severe dysphagia according to the Functional Oral Intake Scale (FOIS)
- •Individuals receiving enteral or parenteral nutrition
- •Individuals under nutritional follow-up in the past 3 months
Arms & Interventions
Nutritional Intervention Group
Participants will receive a tailored diet plan made by a registered dietitian, with follow-ups for 3 months. The plan is based on Dietary Reference Intakes and adapted to Parkinson's disease and constipation management guidelines.
Intervention: Dietitian-Guided Nutritional Intervention (Behavioral)
Control Group
Participants will not receive individualized nutritional support during the study period. They will receive the dietary guidance only after the end of the study (3 months).
Outcomes
Primary Outcomes
Change in weekly bowel movement frequency
Time Frame: Baseline and 90 days
Mean change in the number of spontaneous bowel movements per week from baseline to 12 weeks, based on participant-reported bowel diaries.
Secondary Outcomes
- Change in relative abundance of gut microbial taxa(Baseline and 90 days)