Dietitian-led intervention to manage constipation in Parkinson's disease: Study protocol for a parallel-group randomized controlled trial (NUTRI-GUT-PD).
Dietitian-led intervention to manage constipation in Parkinson's disease: Study protocol for a parallel-group randomized controlled trial (NUTRI-GUT-PD).
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The study site has not been established. Author addresses may differ from where the research occurred.
Rio Grande, BR · Author affiliation
Graduate Program in Medical Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.Location evidence
Porto Alegre, BR · Author affiliation
Graduate Program in Medical Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.Location evidence
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Dietitian support for constipation
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Original abstract
BACKGROUND: Constipation is a frequent non-motor symptom in Parkinson's Disease (PD). Standard care includes dietary and lifestyle guidance or the use of laxatives. Diet represents a promising non-pharmacological approach, but its management in PD is complex and goes beyond simple dietary recommendations. This study protocol aims to examine whether nutritional counseling delivered by a dietitian is more effective than usual care in reducing constipation symptoms in PD patients. METHODS: This 90-day randomized controlled superiority trial uses a parallel-group design. A total of 54 outpatients with PD without dementia and fulfilling the Rome IV criteria for functional constipation will be included. Baseline assessments comprise demographics, nutritional evaluation (anthropometric measurements and sarcopenia indicators), neurological assessment, and the Constipation Scoring System (CSS) scores. Participants will perform stool sample collection for microbiota analysis and will be requested to complete three 24-hour dietary recalls over the subsequent week. After baseline, participants will be randomly allocated to either the control group (usual care) or the intervention group (nutritional counseling delivered by a dietitian). At the first study visit, participants will deliver the stool sample and dietary recalls. The intervention will last for 90 days and will include one in person consultations and bi-weekly follow-up phone calls. Nutritional counseling will address four main topics: healthy eating, food processing, fiber and fluid intake, and levodopa interactions with diet. In addition, participants in the intervention group will receive an individualized diet plan. All baseline assessments will be repeated at the 90-day endpoint. The primary outcome is the change in weekly bowel movement frequency from baseline to day 90, measured through the stool diary. Secondary outcomes include CSS, changes in fecal gut microbiota, macronutrient distribution, diet quality, body composition and sarcopenia indicators. Trial registration number: NCT07213856.