Mediterranean Diet Effects on Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversità degli Studi dell'Insubria
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
PD diagnosis according to international guidelines;
Age between 40 and 85 years;
Naive to medication or with a stable dosage of anti-Parkinson's therapy for at least two weeks;
Hoehn & Yahr stage ≤3;
Disqualifiers
Atypical or secondary parkinsonism;
Underweight (<18.5);
Obesity (BMI>30);
Pregnancy or suspected pregnancy;
Trial design
Design model
Parallel
Treatments tested in this trial
Mediterranean Diet
BehavioralThe 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Intervention group (standard of care + MD)Experimental treatment 1 intervention
Group B: Control group (standard of care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I+II
The primary outcome of this study is the mean (final - baseline) change in disease severity between the control and intervention groups at the end of the intervention, which will be assessed using the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I+II score. Part I of the scale (13 items) investigates non-motor aspects of the disease, whilst part II (13 items) refers to motor aspects. The MDS-UPDRS will be performed at baseline and after 6 months. The scores in each item vary from 0 (normal) to 4(severe), Higher the score, the more severe the condition or symptom.
Time frame
Baseline - 6 monthsSecondary outcomes
1
Immunophenotype
Flow cytofluorimetric assay of the immunophenotype of circulating cells of the adaptive immune system will be performed. The investigated subpopulations include naïve/memory CD4+ and CD8+ T cells, CD4+ helper T subsets (Th1, Th2, and Th17), CD4+ regulatory T cells (conventional, naïve, and activated Treg), monocytes (classical, nonclassical, and intermediate), and Natural Killer (NK CD56 dim CD56 bright) cells.
Time frame
Baseline - 6 months2
Intestinal and Nasal microbiota
In this study, the effect of the MD on the composition (taxonomy) and quantity of the intestinal and nasal microbiota will be evaluated. Both nasal and intestinal microbiota will be analyzed by sequencing the bacterial 16S rRNA gene, which will be amplified using universal bacterial primers to assess the composition and quantity of the intestinal and nasal microbiota. We will examine operational taxonomic units (OTUs) as well as alpha and beta diversity.
Time frame
Baseline - 6 months3
Fecal metabolites
Exposure to phenolic compounds will be assessed by analyzing metabolites and catabolites of (poly)phenols in the collected fecal samples.
Time frame
Baseline - 6 months4
Urinary metabolites
Exposure to phenolic compounds will be assessed by analyzing metabolites and catabolites of (poly)phenols in the collected urinary samples.
Time frame
Baseline - 6 monthsSponsors and contacts
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Università degli Studi dell'Insubria
Lead sponsor
Associazione Parkinson Insubria (AsPI), Section of Varese
Collaborator
University of Piemonte Orientale
Collaborator
Universidade Nova de Lisboa
Collaborator
Source ClinicalTrials.gov