RecruitingNot ApplicableNCT07213856

Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease

Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial

Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

54 participants

Start Date

Apr 2, 2026

Study Type

INTERVENTIONAL

Conditions

Parkinsons Disease (PD)Constipation - Functional

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

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria13

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

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Interventions

BEHAVIORALDietitian-Guided Nutritional Intervention

Participants receive a diet plan and nutritional counseling provided by a registered dietitian, based on a standardized protocol aligned with the Dietary Reference Intakes (DRIs) and adapted for the management of Parkinson's disease and constipation. The intervention includes follow-ups with the dietitian over a 3-month period.