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| Name | Class |
|---|---|
| San Raffaele Cassino, Cassino, Italy | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet Intervention (Group A) | Experimental | Participants receive a structured Mediterranean Diet intervention, including personalized counseling, meal plans, educational sessions and monitoring. |
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| Intensive Physical Activity Intervention (Group B) | Experimental | Participants engage in a supervised structured physical activity program. |
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| Mediterranean Diet + Intensive Physical Activity Combined Intervention (Group C=A+B) | Experimental | Participants will receive both dietary and physical activity interventions. |
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| Controls (Group D) | Active Comparator | Participants continue their usual Parkinson's disease treatments according to clinical guidelines, without any additional specific dietary or exercise interventions provided by the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal Inflammation | Changes in fecal calprotectin (a valid and non-invasive marker of mucosal inflammation) will be assessed using enzyme-linked immunosorbent assay (ELISA). | Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48) |
| Intestinal Permeability |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Fognani | Contact | +39 0652253440 | alice.fognani@uniroma5.it | |
| Lucia Gatta, PhD | Contact | +39 0652253440 | lucia.gatta@sanraffaele.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41959663 | Derived | Fognani A, Rotondo R, Savo Sardaro ML, de Iure A, Gaglione M, Casali M, Leonardi L, Radicati FG, Vacca L, Guescini M, Zeppa SD, Gatta L, Stocchi F, Picconi B, De Pandis MF. Effects of combined Mediterranean diet and physical activity intervention on the gut microbiome and disease progression in individuals with Parkinson's disease: study protocol for a multicenter, randomized controlled pilot study (PRIME study). Front Aging Neurosci. 2026 Mar 25;18:1743490. doi: 10.3389/fnagi.2026.1743490. eCollection 2026. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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It's a 2x2 factorial, randomized, controlled, non-pharmacological intervention pilot study
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| Intensive Physical Activity Intervention | Behavioral | 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. |
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| Control | Other | 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. |
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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. |
| 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). | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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 , | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)Chan |