An interventional study of Mediterranean Diet Intervention and Intensive Physical Activity Intervention in Parkinson's Disease (PD), sponsored by IRCCS San Raffaele Roma. Not yet recruiting at 2 sites in Italy. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Prevention
Among 186 studies in Motor Activity with a site in Italy — 62 open to participants now, 72 under way, none of them phase 3. Motor Activity · Italy.
Among the 186 studies in Motor Activity with a site in Italy, this one is the 79th largest by planned enrollment of the 143 interventional ones, is one of 12 that started in 2026, is one of 130 with no phase, reaches primary completion later than 67 of the 71 other live ones, and was the 164th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →62 of the 186 studies in Motor Activity with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 35 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →186 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 12 started in 2026.
Median enrollment 100 across the 143 interventional studies, 180 across the 43 observational. Of the 88 that completed or were terminated, 3 (3%) have results posted.
8 of 186 have an industry lead sponsor. The 10 most frequent:
IRCCS San Raffaele Roma is the lead sponsor of 71 studies on the registry; 25 are open to participants now.
IRCCS San Raffaele Roma has 2 studies filed under Motor Activity — fewer than ten, so there is no comparison to draw.
13 of the studies in Motor Activity 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 |
|---|---|
| NCT06783387Centro Universitario Ricerca Interdipartimentale Attivita' MotoriaPhysical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach | 2026-12-15 |
| NCT06884631Centro Cardiologico MonzinoMetabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure | 2026-12-31 |
| NCT05934084Fondazione Italiana Linfomi - ETSLifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors | 2027-02-01 |
| NCT03799354Istituti Clinici Scientifici Maugeri SpAStudy on Impact of Maximal Strength Training in Patients With COPD | 2027-02-28 |
| NCT05708443Istituti Clinici Scientifici Maugeri SpAEffect of Combined Endurance Training on ADL and Walking in COPD Patients | 2027-02-28 |
Among the 186 studies in Motor Activity with a site in Italy, from their registry updates:
This 2x2 factorial, randomized, controlled pilot study aims to identify a specific microbiota pattern, which could constitute a biomarker of Parkinson's disease, and to evaluate whether specific pathotypes can be associated with different stages of the disease; furthermore, the investigators are committed to evaluating how and to what extent the changes induced by a personalized nutritional intervention combined with physical exercise affect the symptoms and quality of life of patients.
The study will last 60 months, and the following activities are planned:
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Participants receive a structured Mediterranean Diet intervention, including personalized counseling, meal plans, educational sessions and monitoring.
Behavioral: Mediterranean Diet Intervention
Participants engage in a supervised structured physical activity program.
Behavioral: Intensive Physical Activity Intervention
Participants will receive both dietary and physical activity interventions.
Behavioral: Mediterranean Diet Intervention · Behavioral: Intensive Physical Activity Intervention
Participants continue their usual Parkinson's disease treatments according to clinical guidelines, without any additional specific dietary or exercise interventions provided by the study.
Other: Control
Participants will follow a personalized diet plan over 24 weeks, based on the guidelines of the Mediterranean diet and defined according to their needs and the state of the disease; no food category will be excluded a priori. Individualized nutritional counseling and support materials (weekly meal plans, sample recipes, portion guides) will be provided by a qualified nutritionist. Adherence to the Mediterranean diet will be monitored periodically. Participants will maintain their usual diet during a pre-baseline period of at least 4 weeks, then switch to the Mediterranean plan under the supervision of a nutritionist.
Participants will perform exercise, over 24 weeks, according to WHO recommendations for adults, including those aged ≥ 64 years, to achieve at least 150-300 minutes of moderate-intensity aerobic physical activity, or at least 75-100 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate and vigorous activity during the week. The WHO 2020 also recommend moderate-intensity or greater muscle-strengthening exercises involving alla major muscle groups for 2 or more days per week. Adherence will be monitored during in-person sessions and through wearable devices for activity tracking.
Participants will continue their usual medical management for early Parkinson's disease according to current clinical guidelines, without any additional dietary or exercise interventions provided by the study, and will be monitored through standard follow-up visits but will not receive any study-specific dietary or physical activity programs.
Alpha Diversity of the fecal microbiota.
Changes in fecal microbiota alpha diversity, a measure of the richness and evenness of microbial species within a sample, will be assessed.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Beta Diversity of the fecal microbiota
Changes in fecal microbiota beta diversity, refers to the degree of difference in microbial community composition between different fecal samples, will be assessed.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Enterobacteriaceae species abundance across Parkinson's disease stage
Changes in fecal microbial composition will be assessed. Specifically, we will measure the relative abundance of Enterobacteriaceae species and pathotypes across different stages of Parkinson's disease.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Fecal Microbial relative quantification
Changes in relative quantification
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Intestinal Inflammation
Changes in fecal calprotectin (a valid and non-invasive marker of mucosal inflammation) will be assessed using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Intestinal Permeability
Changes in fecal zonulin will be assessed using enzyme-linked immunosorbent assay (ELISA). The unit for measuring zonulin in stool samples is nanograms per milliliter (ng/mL). The Protein Zonulin is a very important indicator for leaky gut.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in extracellular vesicle concentration (particles/mL) in saliva and plasma will be assessed.
To evaluate the effect of the combined diet and physical activity intervention on extracellular vesicles (EVs), EVs will be isolated from saliva and plasma by serial ultracentrifugation and size-exclusion chromatography. EV concentration and size distribution will be determined by nanoparticle tracking analysis (NTA).
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in protein marker expression in saliva and plasma.
Extracellular Vesicles (EVs)-associated proteins (CD63, CD9, α-synuclein, BDNF, L1CAM, and CD56) will be quantified by dot blot and confirmed by fluorescent NTA and/or cytofluorimetric analysis.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Total score on the Digestion-Associated Quality of Life Questionnaire (DQLQ)
Participants will complete the Digestion-Associated Quality of Life Questionnaire (DQLQ) for a total of 9 statements. Possible totale score ranges from 0 to 9, with a higher score indicates a lower (worse) digestion-associated QoL
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in non-motor symptoms MDS-UPDRS Part I
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I (non-motor symptoms of daily living) scores will be assessed. The minimum score on the MDS-UPDRS Part I is 0 and the maximum is 52, with higher scores representing worse non-motor symptoms of daily living.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in motor symptoms MDS-UPDRS Part II
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (motor symptoms of daily living) scores will be assessed. The minimum score on the MDS-UPDRS Part II is 0 and the maximum is 52, with higher scores representing worse motor symptoms of daily living.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in motor symptoms MDS-UPDRS Part III
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (motor examination) scores will be assessed. The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132, with higher scores representing worse motor symptoms.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in motor symptoms MDS-UPDRS Part IV
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV (motor complications) scores will be assessed. The minimum score on the MDS-UPDRS Part IV is 0 and the maximum is 24, with higher scores representing worse motor complications.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in motor symptoms (H&Y)
Changes in The Hoehn \& Yahr scale (H\&Y) scale will be assessed. H\&Y scale is a system used to describe the progression of motor symptoms in PD - it ranges from Stage 0 (no signs of disease) to Stage 5 (wheelchair-bound or bedridden).
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in movement analysis (TUG)
Changes in the execution time of the Timed Up \& Go (TUG) test-a reliable and valid measure of mobility, balance, walking ability, and fall risk-will be assessed.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Change in postural instability
Changes in Berg Balance Scale (BBS), a 14-item objective measure that assesses static balance and fall risk in adults. Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to independent complete the task ,
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Change in movement analysis - propulsion
Changes in propulsion (anterior-posterior peak acceleration during the lower-limb swing phase, measured by a wearable G-sensor in m/s²) will be assessed.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Change in walking capacity
Changes in the 10-Meter Walking Test, a standardized method used to assess gait speed and functional mobility.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in Gastrointestinal symptoms
Changes in "Gastrointestinal Symptom Rating Scale" (GSRS), a specific tool consisting of 15 items, that are grouped into five symptom clusters: reflux, abdominal pain, indigestion, diarrhea, constipation.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in stool types
Changes in Bristol Stool Scale, a diagnostic medical tool designed to classify the form of human faeces into seven categories (Type 1 and 2: May be difficult to pass, may indicate constipation; Type 3 and 4: Ideal stools; Type 5: Trending toward diarrhea; Type 6 and 7: Diarrhea).
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Change in non-motor symptoms (NMSS)
Changes in Non-motor Symptom Scale (NMSS), a 30-item scale including the following 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems, attention/memory, gastrointestinal, urinary, sexual function and miscellaneous.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in severity of depressive symptomatology
Changes in Beck Depression Inventory-II (BDI-II), a 21-item self-report inventory measuring the severity of depression.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in quality of life
Changes in Parkinson's Disease Questionnaire-39 (PDQ-39), a tool assessing QoL in eight domains (mobility, daily activities, emotional well-being, stigma, social support, knowledge, communication, and physical discomfort). It's a 5-point scale for each of the 39 questions (0=Never; 1=Rarely; 2=Sometimes; 3=Often; 4=Always). The minimum score is 0 means good health, maximum score is 100 means bad health; a higher score indicates a lower QoL.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in cognitive function - Mini-Mental State Examination (MMSE)
Changes in Mini-Mental State Examination (MMSE), a 30-point items to measure cognitive impairment examining functions like registration, attention and calculation, recall, language, ability to follow simple commands and orientation.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Change in cognitive function - Montreal Cognitive Assessment (MoCA)
Changes in Montreal Cognitive Assessment (MoCA), a 10-minute test used to detect cognitive impairment related to PD.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Change in cognitive function - Frontal Assessment Battery (FAB)
Changes in Frontal Assessment Battery (FAB), a 10 minutes tool evaluating the executive functions located in the frontal lobes, consisting of 6 tests that correspond to each specific cognitive or behavioral domain related to the frontal lobes; FAB scores range between 0 and 18, with higher scores representing a better outcome.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)
Changes in cognitive abilities
Changes in Clock Drawing Test, a simple tool used to check for signs of dementia, that measures several cognitive abilities at once, including attention, hearing comprehension, visual memory, and motor skills.
Time frame: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)Chan
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jul 2029, 34 months later.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 34 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele Roma