Constipation - Functional, Parkinsons Disease (PD)
Conditions
Keywords
Microbiota, Diet, Diet, Protein-Restricted, Diet Therapy, Diet, Healthy, Nutrition Therapy, Constipation, Non-Motor Symptoms, Nutritionists
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
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.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weekly bowel movement frequency | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in relative abundance of gut microbial taxa | Baseline and 90 days | Change in the relative abundance of selected bacterial genera associated with constipation and Parkinson's disease, measured by 16S rRNA sequencing of stool samples. |
Countries
Brazil
Contacts
CONTACTMaira Rozenfeld Olchik, PhD
PRINCIPAL_INVESTIGATORMaira Rozenfeld Olchik, PhD
Federal University of Rio Grande do Sul
Outcome results
None listed