Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
NCT ID: NCT07213856
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
54 participants
INTERVENTIONAL
2025-10-31
2029-08-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Dietitian-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.
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).
No interventions assigned to this group
Interventions
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Dietitian-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On a stable dose of levodopa for at least 3 months
* Diagnosis of Functional Constipation by the Rome IV protocol
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Maira Rozenfeld Olchik, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Rio Grande do Sul
Locations
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Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Food and Nutrition Board; Committee on the Dietary Reference Intakes for Energy. Dietary Reference Intakes for Energy. Washington (DC): National Academies Press (US); 2023 Jan 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK588659/
Barichella M, Cereda E, Cassani E, Pinelli G, Iorio L, Ferri V, Privitera G, Pasqua M, Valentino A, Monajemi F, Caronni S, Lignola C, Pusani C, Bolliri C, Faierman SA, Lubisco A, Frazzitta G, Petroni ML, Pezzoli G. Dietary habits and neurological features of Parkinson's disease patients: Implications for practice. Clin Nutr. 2017 Aug;36(4):1054-1061. doi: 10.1016/j.clnu.2016.06.020. Epub 2016 Jul 5.
Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
Other Identifiers
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2025-0374
Identifier Type: -
Identifier Source: org_study_id
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