Could a mediterranean diet and exercise ease Parkinson's by reshaping the gut?

NCT ID NCT07097103

Disease control Sponsor: IRCCS San Raffaele Roma Source: ClinicalTrials.gov ↗

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This pilot study tests whether a Mediterranean diet and regular exercise can alter the gut microbiome in people with Parkinson's disease. Researchers will track changes in gut bacteria and look for links to symptom severity and quality of life. The study involves 80 participants aged 35–80 with mild to moderate Parkinson's.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Mediterranean diet and physical exercise
What this could lead to: If it works, this could point toward a non-drug way to manage Parkinson's symptoms by targeting the gut microbiome.
What could go wrong: This is a small pilot study, so results may not apply to everyone. The diet and exercise plan requires commitment, and benefits may be modest or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Motor Activity Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson'S disease (PD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a mediterranean diet and exercise ease Parkinson's by reshaping the gut?

What the study statuses mean