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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Intervention Group | Experimental | 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. |
|
| Control Group | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietitian-Guided Nutritional Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dietary intake | Variation in intake of macronutrients and fiber, assessed through 24h food records. | Baseline, 45 days and 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maira Rozenfeld Olchik, PhD | Contact | +55 (51) 33083020 | molchik@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Maira Rozenfeld Olchik, PhD | Federal University of Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre (HCPA) | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36693139 | Background | 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/ | |
| 27406858 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
| 27147121 | Background | 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. |
| 26474316 | Background | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |