Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT07097103
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Parkinson's disease according to United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria;
* aged 35-80 years;
* Hoehn \& Yahr stage \> 1 and \< 3 in the clinical "ON" state;
* MoCA score ≥17.54;
* MMSE ≥24;
* Stable dopaminergic midication regimen for ≥ 4 weeks;
* Ability to interact with the research team and provide informed consent in Italian;
* Suitable to physical exercise;
* Able to walk unassisted (no walking aids);
* Willingness and ability to comply with all study procedures;
* Willingness to maintain usual diet during a ≥ 4-week pre-baseline period;
* Willingness to switch to a Mediterranean-style diet during the intervention;
* Ability to provide stool samples at each collection timepoint;
* Willing to avoid strenuous exercise and alcohol for 24 hours prior to each visits.
Exclusion Criteria:
* Pre-existing psychiatric disorders;
* Atypical or secondary Parkinsonism;
* Presence of pacemakers or other subcutaneous electronic devices;
* Any other neurological or neurodegenerative disorders;
* Moderate to severe cognitive decline;
* Beck Depression Inventory-II (BDI-II)\] score ≥28;
* Dementia diagnosis;
* Thyroid dysfunctions;
* Type1 Diabetes Mellitus;
* Type 2 diabetes mellitus with HbA₁c ≥ 8% or on insulin therapy;
* Acute diseases;
* Active Neoplasia;
* IBD or IBS;
* Celiac disease;
* History of major gastrointestinal surgery or acute GI conditions (e.g., gastroenteritis) within the past 3-6 months;
* Chronic corticosteroid therapy;
* Use of proton pump inhibitors within the past 30 days;
* Acute, antibiotic-resistant infections;
* Antibiotic intake within the past 30 days;
* Prebiotic/probiotic supplement use in the past 30 days;
* Prolonged intake of anxiolytic drugs, antidepressants, antipsychotics, cognitive stimulants, and analogs in the past 3 months;
* Underweight (BMI \<18.5);
* History of deep brain stimulation (DBS) surgery;
* Pregnancy or lactation;
* Regular use of enemas or suppositories to alleviate constipation;
* Use of experimental products in the 3 months prior to the screening visit
* Patients who, for medical reasons, are required to follow special dietary regimens that could interfere with the adoption or effectiveness of the Mediterranean model;
* Vegan/Vegetarian diet or any other dietary behaviour that excludes one or more of the typical food groups of the Mediterranean model.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT07097103
Study Brief:
Protocol Section:
NCT07097103