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โ† Trials
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Mediterranean Diet Effects on Parkinson's Disease

RecruitingNAAges 40 Years - 85 YearsAllUniversitร  degli Studi dell'Insubria
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In plain words

What the trial is, and whether it could suit you

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 eva

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. PD diagnosis according to international guidelines; 2. Age between 40 and 85 years; 3. Naive to medication or with a stable dosage of anti-Parkinson's therapy for at least two weeks; 4. Hoehn \& Yahr stage โ‰ค3; 5. Normal independent feeding; 6. Ability to complete informed consent; 7. Willingness to maintain the usual diet in the period between T0 and T1; 8. Willingness to maintain the usual diet if randomized to the control group in the T1-T2 period; 9. Willingness to make changes in their diet to follow a Mediterranean diet if randomized to the intervention group in the T1-T2 period; 10. Willingness to fill out questionnaires; 11. Willingness to provide blood samples during the study collection periods; 12. Willingness to provide stool samples during the study collection periods; 13. Willingness to fast (without food or drink except water, tea or coffee) at least 12 hours before each sample collection; 14. 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; 15. No medical and/or social conditions that could interfere with participation in a six-month interventional study. Exclusion Criteria: 1. Atypical or secondary parkinsonism; 2. Underweight (\<18.5); 3. Obesity (BMI\>30); 4. Pregnancy or suspected pregnancy; 5. Normal assisted nutrition; 6. Enteral nutrition; 7. Chronic autoimmune diseases; 8. Chronic use of immunosuppressive drugs in the past year; 9. Chronic use of cytotoxic cancer drugs in the past year; 10. Major abdominal surgeries; 11. Concurrent participation in other interventional studies; 12. Intentional change in diet after PD diagnosis.
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What it tests

  • Mediterranean Diet
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Where

1 site
Centre for Research in Medical Pharmacology
Varese, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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