An interventional study of Mediterranean Diet in Parkinson, Parkinson Disease and Parkinson Disease, Idiopathic, sponsored by Università degli Studi dell'Insubria. Recruiting at 1 site in Italy. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Università degli Studi dell'Insubria · Not applicable, Interventional, and Supportive care
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Among 347 studies in Parkinson Disease with a site in Italy — 90 open to participants now, 108 under way, 4 of them phase 3. Parkinson Disease · Italy.
Among the 347 studies in Parkinson Disease with a site in Italy, this one is the 168th largest by planned enrollment of the 244 interventional ones that give a count, is one of 28 that started in 2025, is one of 146 with no phase, reaches primary completion later than 33 of the 107 other live ones, and was the 288th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →90 of the 347 studies in Parkinson Disease with a site in Italy are open now. Recruiting first, the newest first:
University Hospital Tuebingen · Sites in Italy, France, Germany and 4 more countries
Ages 35–80
Newronika · Sites in Italy
Ages 18+
University Hospital of Ferrara · Sites in Italy
Ages 18+
Universita di Verona · Sites in Italy
Ages 18+
Neuromed IRCCS · Sites in Italy
Ages 18+ · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
347 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 37 · Phase 3 49 · Phase 4 13
First in 2002; this study’s year is marked. 28 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 44 is close to the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 82 across the 244 interventional studies, 145 across the 102 observational. Of the 184 that completed or were terminated, 50 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
109 of 347 have an industry lead sponsor. The 10 most frequent:
Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
Università degli Studi dell'Insubria has 1 study filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
22 of the studies in Parkinson Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502066IRCCS San Camillo, Venezia, ItalyClinical Efficacy of a telerehabilItation Protocol, for the Improvement of Balance in Degenerative Neurological Diseases | 2026-12 |
| NCT07485218University of Applied Sciences and Arts of Southern SwitzerlandMultidimensional Assessment of Fatigability in Older Adults Living in Southern Switzerland and Elderly With Parkinson's Disease | 2026-12 |
| NCT07637123IRCCS San Raffaele RomaEvaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients | 2026-12 |
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
| NCT06814431Azienda USL Reggio Emilia - IRCCSStudy on the Incidence of Malignant Neoplasms in Patients With Parkinson's Disease and Heterozygous Mutation of the GBA Gene | 2026-12 |
Add all 22 to your calendar (.ics) → With an account.
Among the 347 studies in Parkinson Disease with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
PD is a progressive neurodegenerative disorder marked by both motor and non-motor symptoms, leading to reduced quality of life and increased economic burden for patients and caregivers. Prior to diagnosis, patients often experience a prodromal phase characterized by symptoms such as anosmia, constipation, and sleep disturbances. PD is the second most common neurodegenerative disease globally and the fastest-growing, with an increasing prevalence since 1990.
The disease is linked to the buildup of α-synuclein in Lewy bodies within the brain and neuroinflammation caused by microglial activation. This process results in the degeneration of dopaminergic neurons in the substantia nigra, which is central to PD pathology. Recent research has highlighted the role of immune dysfunction in PD, with alterations observed in adaptive and innate immune responses. A reduction in specific T cells (e.g., CD4+ T cells, Th2, Th17, and T regulatory cells) and a shift towards a pro-inflammatory Th1 response have been associated with neuronal damage in PD. Moreover, aberrant α-synuclein may trigger an adaptive immune response, highlighting the relevance of the immune system as a potential therapeutic target.
Gut and nasal microbiota also appear to play a role in PD. Alterations in the gut microbiome, including changes in short-chain fatty acid-producing bacteria, have been observed in PD patients. Notably, increases in Lactobacillus, Akkermansia, and Bifidobacterium have been reported in the gut, while the Lachnospiraceae family and Faecalibacterium genus are reduced.
Moreover, although still unconfirmed, nasal microbiota may contribute to neurodegeneration by traveling through the olfactory and trigeminal pathways, possibly initiating or exacerbating brain inflammation.
Evidence suggests that specific dietary patterns may influence PD risk and progression. Foods like dairy are associated with an increased risk of PD, while coffee, nicotine-containing vegetables (e.g., peppers and tomatoes), and high consumption of vegetables, nuts, and fish may reduce symptomatology.
The MD, a plant-based diet rich in vegetables, fruits, whole grains, and healthy fats like olive oil, has been linked to numerous health benefits, including improved cognitive function, cardiovascular health, and a reduced risk of developing PD.
Studies show that a high-fiber diet can positively impact α-synuclein aggregation and microglial activation. Adherence to the MD may lower PD risk by up to 26%, slow disease progression, and improve both motor and non-motor symptoms. In contrast to pharmacological treatments, the MD has minimal side effects and could address several unmet needs in PD management, particularly in slowing disease progression and reducing comorbidities such as dementia.
This six-month randomized controlled trial aims to explore whether strict adherence to the MD can stabilize or slow the progression of motor and non-motor symptoms in PD patients. It will also investigate the impact of the MD on the immune system, gut and nasal microbiota, and fecal metabolomics, making it the first trial to assess these factors together. The study's primary goal is to determine the benefits of MD adherence on symptom management while also exploring correlations between immune function, microbiota composition, fecal and urinary metabolomics, and diet adherence levels.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group will participate in a six-month program aimed at promoting adherence to the MD. At the start, participants will be given a physical booklet outlining foods to prioritize and avoid. They will also receive monthly recipes featuring seasonal ingredients. In addition, cooking classes will be offered, with caregiver involvement encouraged.
Behavioral: Mediterranean Diet
The control group will be asked to maintain their current dietary habits and usual standard care. They will undergo the same routine examinations and check-ups as the intervention group.
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.
Also known as: Dietary intervention
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 months
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 months
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 months
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 months
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 months
Non-Motor Symptom Scale (NMSS)
The NMSS is a 30-item rater-based scale that assesses the severity and frequency of non-motor symptoms across nine dimensions. Total scores range from 0 to 360, with higher scores indicating greater symptom burden.
Time frame: Baseline - 6 months
Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is a partly rater-based and partly patient-based questionnaire that assesses disease severity through 65 items divided into four domains: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). The MDS-UPDRS is designed to assess the presence and severity of clinically relevant problems in various domains. Scores range from 0 to 272, with higher scores indicating greater severity. The full MDS-UPDRS will be assessed by the study neurologist during in-person visits. For each domain of the MDS-UPDRS and for the total scores of the MDS-UPDRS within each of the two study arms, baseline and final scores will be collected for each patient and each domain.
Time frame: Baseline - 6 months
GSRS (Gastrointestinal Symptom Rating Scale)
The GSRS is a self-reported 15-item questionnaire that assesses the severity of gastrointestinal symptoms over the course of one week. It evaluates the severity of gastrointestinal symptoms across five domains: reflux, abdominal pain, indigestion, diarrhea, and constipation. Scores range from 1 to 7, with higher scores indicating greater symptom severity.
Time frame: Baseline - 6 months
The Pac-QoL (Patient Assessment of Constipation Quality of Life)
The Pac-QoL is a self-reported 28-item questionnaire assessing the quality of life-related to constipation over the past two weeks. The PAC-QOL measures the impact of constipation on quality of life across four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction. Scores range from 0 to 4, with higher scores indicating greater negative impact and lower scores reflecting better quality of life
Time frame: Baseline - 6 months
Diet adherence - MEDAS (Mediterranean Diet Adherence Screener)
The MEDAS questionnaire is a self-reported 14-item questionnaire that investigates eating habits and will allow the measurement of adherence to the MD, diet modification, and effectiveness of the lifestyle intervention. The MEDAS assesses adherence to the Mediterranean diet through 14 items, each scored as 1 (criterion met) or 0 (not met). Total scores range from 0 to 14, with ≥9 indicating good adherence and \<9 reflecting moderate or low adherence. Higher scores suggest better alignment with Mediterranean dietary patterns, often linked to improved health outcomes.
Time frame: Baseline - 6 months
Quality of life - SF-36 (36-Item Short Form Health Survey)
The SF-36 is a standardized tool for assessing health-related quality of life across eight domains. Each domain is scored on a scale from 0 to 100, with 0 representing the poorest health and 100 representing the best possible health. These domains evaluate various aspects of physical and mental health, including physical functioning, bodily pain, vitality, and mental well-being.
Time frame: Baseline - 6 months
Body Mass Index (BMI)
Height will be measured while standing without shoes. Weight will be recorded without footwear and in light clothing using a digital scale with a precision of 100 grams. BMI will be determined by dividing weight by the square of height, expressed in kilograms per square meter (kg/m²).
Time frame: Baseline - 6 months
Waist circumference
Waist circumference will be measured according to the WC-mid protocol, following World Health Organization recommendations
Time frame: Baseline - 6 months
Daily Levodopa Equivalent Dose
Levodopa equivalents will be calculated using the free platform EQUIDopa to assess the intensity of dopaminergic replacement therapy and facilitate the confrontation of different therapy schedules. Physicians will collect data during inpatient visits at baseline and after 6 months.
Time frame: Baseline - 6 months
Complete blood count with formula
Collect the data of complete blood count with formula from blood test
Time frame: Baseline - 6 months
Total Cholesterol
Collect the data of serum concentration of Total Cholesterol from blood test
Time frame: Baseline - 6 months
HDL Cholesterol
Collect the data of serum concentration of HDL Cholesterol from blood test
Time frame: Baseline - 6 months
LDL Cholesterol
Collect the data of serum concentration of LDL Cholesterol from blood test
Time frame: Baseline - 6 months
Triglycerides
Collect the data of serum Triglycerides levels from blood test
Time frame: Baseline - 6 months
Glycemia
Collect the data of glucose levels from blood test
Time frame: Baseline - 6 months
GOT (transaminase)
Collect the data of GOT from blood test
Time frame: Baseline - 6 months
GPT (transaminase)
Collect the data of GOT from blood test
Time frame: Baseline - 6 months
Gamma-glutamyl transferase
Collect the data of Ggt from blood test
Time frame: Baseline - 6 months
Erythrocyte Sedimentation Rate
Collect the data of erythrocyte Sedimentation Rate from blood test
Time frame: Baseline - 6 months
Creatinine
Collect the data on creatinine levels from blood test
Time frame: Baseline - 6 months
Azotemia
Collect the data on nitrogen-containing compounds from blood test
Time frame: Baseline - 6 months
Uricemia
Collect the data on uric acid levels from blood test
Time frame: Baseline - 6 months
Plan to share: Yes — After publication, upon reasonable request, the anonymized dataset will be provided.
Supporting information: Study protocol, Informed consent form
Time frame: After the study conclusion and publication of results
Started Jan 2025 (actual). Primary completion is estimated for Feb 2026, 13 months after the start.
Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 13 months is below that.
Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Università degli Studi dell'Insubria