Mediterranean Diet Effects on Parkinson's Disease

Launched by UNIVERSITÀ DEGLI STUDI DELL'INSUBRIA · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of the Mediterranean diet on patients with Parkinson's disease (PD). Researchers want to see if following this diet can help improve both movement and non-movement symptoms, enhance quality of life, and potentially slow down disease progression. The Mediterranean diet is rich in fruits, vegetables, whole grains, and healthy fats, and some studies suggest it may benefit people with Parkinson's. In this study, 44 participants aged 40 to 85 will be divided into two groups: one group will continue their usual diet, while the other will follow the Mediterranean diet for six months.

To be eligible for the trial, participants must have a confirmed diagnosis of Parkinson's disease, be between 40 and 85 years old, and either not be on any medication or be on a stable dose of PD medication for at least two weeks. Participants should also be able to eat independently and complete questionnaires about their health. Throughout the study, individuals will provide blood and stool samples, and their symptoms and quality of life will be assessed before and after the six-month period. This trial is not yet recruiting participants, but it aims to gather valuable information about how dietary changes might help those living with Parkinson's disease.

Gender

ALL

Eligibility criteria

• 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 ≤3;
• • 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.