ParkinsonMED-PARKNCT06705517
Mediterranean Diet Effects on Parkinson's Disease
A study testing Mediterranean Diet in people with Parkinson and Parkinson Disease, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson, Parkinson Disease, Parkinson Disease, Idiopathic
- What is being tested?
- Mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Normal independent feeding;
- Ability to complete informed consent;
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- Willingness to maintain the usual diet in the period between T0 and T1;
- Willingness to maintain the usual diet if randomized to the control group in the T1-T2 period;
- Willingness to make changes in their diet to follow a Mediterranean diet if randomized to the intervention group in the T1-T2 period;
- Willingness to fill out questionnaires;
- Willingness to provide blood samples during the study collection periods;
- Willingness to provide stool samples during the study collection periods;
- Willingness to fast (without food or drink except water, tea or coffee) at least 12 hours before each sample collection;
- Willingness to discontinue taking supplements, probiotics, herbal or high- dose vitamins or minerals that could impact inflammation during the period between T0 and T1 and for the duration of the study protocol;
- No medical and/or social conditions that could interfere with participation in a six-month interventional study.
Who cannot join
- Atypical or secondary parkinsonism;
- Underweight (<18.5);
- Obesity (BMI>30);
- Pregnancy or suspected pregnancy;
- Normal assisted nutrition;
- Enteral nutrition;
Show all 12Show fewer
- Chronic autoimmune diseases;
- Chronic use of immunosuppressive drugs in the past year;
- Chronic use of cytotoxic cancer drugs in the past year;
- Major abdominal surgeries;
- Concurrent participation in other interventional studies;
- Intentional change in diet after PD diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centre for Research in Medical Pharmacology
Varese, Varese, 21100
Marco Cosentino, MD, PhD, +39 0332217427, marco.cosentino@uninisubria.it
Franca Marino, M.Sc., PhD, franca.marino@uninsubria.it
About this study
Official title: Mediterranean Diet Effects on Parkinson's Disease (MED-PARK): a Randomized Controlled 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).
Read more
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.
Read the detailed description
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.
- Being tested
- Mediterranean Diet
- Keywords
- Diet, Mediterranean Diet, Parkinson, Parkinson disease, MIND diet, plant based diet, unprocessed diet
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
Also called Dietary intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (standard of care + MD) | Experimental | 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. Receives: Behavioral: Mediterranean Diet |
| Control group (standard of care) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 6 months
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline - 6 months
Waist circumference
Waist circumference will be measured according to the WC-mid protocol, following World Health Organization recommendations
Measured: 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.
Measured: Baseline - 6 months
Complete blood count with formula
Collect the data of complete blood count with formula from blood test
Measured: Baseline - 6 months
Total Cholesterol
Collect the data of serum concentration of Total Cholesterol from blood test
Measured: Baseline - 6 months
HDL Cholesterol
Collect the data of serum concentration of HDL Cholesterol from blood test
Measured: Baseline - 6 months
LDL Cholesterol
Collect the data of serum concentration of LDL Cholesterol from blood test
Measured: Baseline - 6 months
Triglycerides
Collect the data of serum Triglycerides levels from blood test
Measured: Baseline - 6 months
Glycemia
Collect the data of glucose levels from blood test
Measured: Baseline - 6 months
GOT (transaminase)
Collect the data of GOT from blood test
Measured: Baseline - 6 months
GPT (transaminase)
Collect the data of GOT from blood test
Measured: Baseline - 6 months
Gamma-glutamyl transferase
Collect the data of Ggt from blood test
Measured: Baseline - 6 months
Erythrocyte Sedimentation Rate
Collect the data of erythrocyte Sedimentation Rate from blood test
Measured: Baseline - 6 months
Creatinine
Collect the data on creatinine levels from blood test
Measured: Baseline - 6 months
Azotemia
Collect the data on nitrogen-containing compounds from blood test
Measured: Baseline - 6 months
Uricemia
Collect the data on uric acid levels from blood test
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start17 Jan 2025
- Primary completionFeb 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional, non-pharmacological, superiority, randomized, controlled, single-center, masked study with two parallel groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Parkinson Insubria (AsPI), Section of Varese, University of Piemonte Orientale, Universidade Nova de Lisboa
- Responsible party
- Principal investigator, Franca Marino, Università degli Studi dell'Insubria
- Investigators
- Marco Cosentino, MD, PhD, Principal investigator, Università degli studi dell InsubriaFranca Marino, M.Sc., PhD, Principal investigator, Università degli studi dell InsubriaElenamaria Pirovano, MD, Principal investigator, Università degli studi dell Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705517
- Sponsor's protocol ID
- MED-PARK
- Acronym
- MED-PARK
- Status last verified
- Mar 2025
- First submitted
- 14 Nov 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, upon reasonable request, the anonymized dataset will be provided.
Publications
Kustrimovic N, Rasini E, Legnaro M, Bombelli R, Aleksic I, Blandini F, Comi C, Mauri M, Minafra B, Riboldazzi G, Sanchez-Guajardo V, Marino F, Cosentino M. Dopaminergic Receptors on CD4+ T Naive and Memory Lymphocytes Correlate with Motor Impairment in Patients with Parkinson's Disease. Sci Rep. 2016 Sep 22;6:33738. doi: 10.1038/srep33738.
PubMed 27652978Kustrimovic N, Comi C, Magistrelli L, Rasini E, Legnaro M, Bombelli R, Aleksic I, Blandini F, Minafra B, Riboldazzi G, Sturchio A, Mauri M, Bono G, Marino F, Cosentino M. Parkinson's disease patients have a complex phenotypic and functional Th1 bias: cross-sectional studies of CD4+ Th1/Th2/T17 and Treg in drug-naive and drug-treated patients. J Neuroinflammation. 2018 Jul 12;15(1):205. doi: 10.1186/s12974-018-1248-8.
PubMed 30001736Pirovano E, Marino F, Rossi E, Gennari A, Rasini E, Uslenghi M, Figueira I, Iacoviello L, Ferrari M, Cosentino M. Modified Mediterranean diet effects on Parkinson's disease (MED-PARK): a single-centre randomised controlled trial protocol. BMJ Open. 2025 Oct 5;15(10):e101946. doi: 10.1136/bmjopen-2025-101946.
PubMed 41047258
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet Effects on Parkinson's Disease (MED-PARK): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06705517
- Acronym / sponsor ID
- MED-PARK / MED-PARK
- Keywords
- Diet, Mediterranean Diet, Parkinson, Parkinson disease, MIND diet, plant based diet, unprocessed diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Collaborators
- Associazione Parkinson Insubria (AsPI), Section of Varese, University of Piemonte Orientale, Universidade Nova de Lisboa
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is an interventional, non-pharmacological, superiority, randomized, controlled, single-center, masked study with two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (standard of care + MD) | Experimental | Behavioral: Mediterranean DietThe 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. |
| Control group (standard of care) | No intervention | –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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
- Normal independent feeding;
Key exclusion criteria (12 listed)
- Atypical or secondary parkinsonism;
- Underweight (<18.5);
- Obesity (BMI>30);
- Pregnancy or suspected pregnancy;
- Normal assisted nutrition;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietAlso: Dietary interventionThe 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. | Behavioural | Intervention group (standard of care + MD) |
Primary outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I+II
Time frame: Baseline - 6 months
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.
26 secondary outcomes
Immunophenotype
Time frame: Baseline - 6 months
Intestinal and Nasal microbiota
Time frame: Baseline - 6 months
Fecal metabolites
Time frame: Baseline - 6 months
Urinary metabolites
Time frame: Baseline - 6 months
Non-Motor Symptom Scale (NMSS)
Time frame: Baseline - 6 months
Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline - 6 months
GSRS (Gastrointestinal Symptom Rating Scale)
Time frame: Baseline - 6 months
The Pac-QoL (Patient Assessment of Constipation Quality of Life)
Time frame: Baseline - 6 months
Diet adherence - MEDAS (Mediterranean Diet Adherence Screener)
Time frame: Baseline - 6 months
Quality of life - SF-36 (36-Item Short Form Health Survey)
Time frame: Baseline - 6 months
Body Mass Index (BMI)
Time frame: Baseline - 6 months
Waist circumference
Time frame: Baseline - 6 months
Daily Levodopa Equivalent Dose
Time frame: Baseline - 6 months
Complete blood count with formula
Time frame: Baseline - 6 months
Total Cholesterol
Time frame: Baseline - 6 months
HDL Cholesterol
Time frame: Baseline - 6 months
LDL Cholesterol
Time frame: Baseline - 6 months
Triglycerides
Time frame: Baseline - 6 months
Glycemia
Time frame: Baseline - 6 months
GOT (transaminase)
Time frame: Baseline - 6 months
GPT (transaminase)
Time frame: Baseline - 6 months
Gamma-glutamyl transferase
Time frame: Baseline - 6 months
Erythrocyte Sedimentation Rate
Time frame: Baseline - 6 months
Creatinine
Time frame: Baseline - 6 months
Azotemia
Time frame: Baseline - 6 months
Uricemia
Time frame: Baseline - 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 27652978Kustrimovic N, Rasini E, Legnaro M, Bombelli R, Aleksic I, Blandini F, Comi C, Mauri M, Minafra B, Riboldazzi G, Sanchez-Guajardo V, Marino F, Cosentino M. Dopaminergic Receptors on CD4+ T Naive and Memory Lymphocytes Correlate with Motor Impairment in Patients with Parkinson's Disease. Sci Rep. 2016 Sep 22;6:33738. doi: 10.1038/srep33738.
- Background: PubMed 30001736Kustrimovic N, Comi C, Magistrelli L, Rasini E, Legnaro M, Bombelli R, Aleksic I, Blandini F, Minafra B, Riboldazzi G, Sturchio A, Mauri M, Bono G, Marino F, Cosentino M. Parkinson's disease patients have a complex phenotypic and functional Th1 bias: cross-sectional studies of CD4+ Th1/Th2/T17 and Treg in drug-naive and drug-treated patients. J Neuroinflammation. 2018 Jul 12;15(1):205. doi: 10.1186/s12974-018-1248-8.
- Derived from this study: PubMed 41047258Pirovano E, Marino F, Rossi E, Gennari A, Rasini E, Uslenghi M, Figueira I, Iacoviello L, Ferrari M, Cosentino M. Modified Mediterranean diet effects on Parkinson's disease (MED-PARK): a single-centre randomised controlled trial protocol. BMJ Open. 2025 Oct 5;15(10):e101946. doi: 10.1136/bmjopen-2025-101946.
- Individual participant dataSharing planned: Yes. After publication, upon reasonable request, the anonymized dataset will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Cosentino, MD, PhD principal investigator
Università degli studi dell Insubria
Franca Marino, M.Sc., PhD principal investigator
Università degli studi dell Insubria
Elenamaria Pirovano, MD principal investigator
Università degli studi dell Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet in people with Parkinson and Parkinson Disease, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Cosentino, MD, PhD (0332217427 ext. +39, marco.cosentino@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) I+II (time frame: Baseline - 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.