RecruitingNot ApplicableNCT06705517

Mediterranean Diet Effects on Parkinson's Disease

Mediterranean Diet Effects on Parkinson's Disease (MED-PARK): a Randomized Controlled Trial


Sponsor

Università degli Studi dell'Insubria

Enrollment

44 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Currently, there are no disease-modifying treatments for Parkinson's disease (PD), the second most common neurodegenerative disorder worldwide, making it crucial to find interventions that can change the disease's trajectory. Epidemiological studies suggest that the Mediterranean diet (MD) is linked to improved motor and non-motor symptoms, slower disease progression, and lower mortality in PD patients. However, few interventional studies have explored this connection. This study assesses whether an MD can improve motor and non-motor symptoms in PD patients. Additionally, the study will examine the effects of the diet on a patient's quality of life, gastrointestinal symptomatology, adaptive immune system, fecal and nasal microbiome, and fecal and urinary metabolomics. This is a randomized, controlled, non-pharmacological, single-center, masked trial with two parallel groups. It will evaluate the safety and efficacy of the MD on motor and non-motor symptoms reported by PD patients. Forty-four participants, aged 40-85, meeting the inclusion criteria will be enrolled and block-randomized into two groups: one maintaining their usual diet (control) and the other following a MD for six months (intervention). The primary outcome is patient-reported symptoms, measured using the MDS-UPDRS I+II score. Secondary outcomes include the analysis of adaptive immune system cells, nasal and fecal microbiome composition, and inflammatory and metabolic markers. Additional assessments include disease severity (MDS-UPDRS), non-motor symptoms (Non-Motor Symptoms Scale), participant well-being (36-Item Short Form Health Survey), gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale and Patient Assessment of Constipation Quality of Life), and the intensity of dopaminergic therapy (levodopa equivalents). Evaluations will be performed at baseline and after six months.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether following a Mediterranean diet can improve symptoms, slow disease progression, and affect gut bacteria in people with Parkinson's disease. **You may be eligible if...** - You have been diagnosed with Parkinson's disease according to standard guidelines - You are between 40 and 85 years old - You are either not on Parkinson's medication, or your medication dose has been stable for at least two weeks - Your Parkinson's disease is in an early-to-moderate stage (Hoehn & Yahr stage 3 or less) - You can eat independently and are willing to follow dietary instructions and provide blood and stool samples **You may NOT be eligible if...** - You have significant difficulty eating independently - You have dementia or severe cognitive impairment - You have conditions that would make dietary changes unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMediterranean Diet

The MD emphasizes a plant-based approach, with a high consumption of vegetables, fruits, whole grains, legumes, and nuts, alongside moderate amounts of fish, seafood, and dairy, while limiting meat, particularly red and processed varieties. Olive oil serves as the main fat source in the diet. In the case of this study participants will also be instructed to limit dairy intake, that although traditionally part of the MD, might exacerbate disease symptomatology in PD patients, likely due to the urate lowering effect of dairy.


Locations(1)

Centre for Research in Medical Pharmacology

Varese, Varese, Italy

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NCT06705517


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