Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dietitian-Guided Nutritional Intervention
BehavioralParticipants 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.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Nutritional Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in weekly bowel movement frequency
Mean change in the number of spontaneous bowel movements per week from baseline to 12 weeks, based on participant-reported bowel diaries.
Time frame
Baseline and 90 daysSecondary outcomes
1
Change in relative abundance of gut microbial taxa
Change in the relative abundance of selected bacterial genera associated with constipation and Parkinson's disease, measured by 16S rRNA sequencing of stool samples.
Time frame
Baseline and 90 daysOther outcomes
1
Change in dietary intake
Variation in intake of macronutrients and fiber, assessed through 24h food records.
Time frame
Baseline, 45 days and 90 daysSponsors and contacts
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Source ClinicalTrials.gov