Condition: Parkinson · Parkinson Disease · Parkinson Disease, Idiopathic · Sponsor: Università degli Studi dell'Insubria
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 …
This description comes directly from the study's public registry record.
Marco Cosentino, MD, PhD · 0332217427 · marco.cosentino@uninsubria.it
Franca Marino, M.Sc., PhD · 0332217427 · franca.marino@uninsubria.it
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| Centre for Research in Medical Pharmacology | Varese, Varese, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06705517