BridgeMD
New treatment option for Parkinson
Official title Mediterranean Diet Effects on Parkinson's Disease
ClinicalTrials.gov ID: NCT06705517
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- PD diagnosis according to international guidelines;
- Age between 40 and 85 years;
- Naive to medication or with a stable dosage of anti-Parkinson's therapy for at least two weeks;
- Hoehn \& Yahr stage ≤3;
- Normal independent feeding;
You likely can't join if
- Atypical or secondary parkinsonism;
- Underweight (\<18.5);
- Obesity (BMI\>30);
- Pregnancy or suspected pregnancy;
- Normal assisted nutrition;
- Enteral nutrition;
See the full eligibility criteria
- PD diagnosis according to international guidelines;
- Age between 40 and 85 years;
- Naive to medication or with a stable dosage of anti-Parkinson's therapy for at least two weeks;
- Hoehn \& Yahr stage ≤3;
- Normal independent feeding;
- Ability to complete informed consent;
- Willingness to maintain the usual diet in the period between T0 and T1;
- Willingness to maintain the usual diet if assigned by chance to the control group in the T1-T2 period;
- Willingness to make changes in their diet to follow a Mediterranean diet if assigned by chance to the intervention group in the T1-T2 period;
- Willingness to fill out questionnaires;
- Willingness to provide blood samples during the study collection periods;
- Willingness to provide stool samples during the study collection periods;
- Willingness to fast (without food or drink except water, tea or coffee) at least 12 hours before each sample collection;
- 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;
- No medical and/or social conditions that could interfere with participation in a six-month treatment study.
- Atypical or secondary parkinsonism;
- Underweight (\<18.5);
- Obesity (BMI\>30);
- Pregnancy or suspected pregnancy;
- Normal assisted nutrition;
- Enteral nutrition;
- Chronic autoimmune diseases;
- Chronic use of immunosuppressive drugs in the past year;
- Chronic use of cytotoxic cancer drugs in the past year;
- Major abdominal surgeries;
- Concurrent participation in other treatment studies;
- Intentional change in diet after PD diagnosis.
The study team makes the final eligibility decision.
Where it's taking place
- Varese, Varese, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Varese, Varese, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.