Evidence map›Paper›PMID 41959663›Full record

ArticleFrontiers in aging neuroscience2026

Effects of combined Mediterranean diet and physical activity intervention on the gut microbiome and disease progression in individuals with Parkinson's disease: study protocol for a multicenter, randomized controlled pilot study (PRIME study).

Alice Fognani, Rossella Rotondo, Maria Luisa Savo Sardaro, Antonio de Iure, Maria Gaglione, Miriam Casali, Lorenza Leonardi, Fabiana Giada Radicati, Laura Vacca, Michele Guescini and 5 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in aging neuroscience, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07097103 (A 2x2 Factorial Randomized Controlled Non-pharmacological Interventional Multicenter Pilot Study on the Influence of the Mediterranean Diet and Physical Exercise on the Microbiome of Patients With Parkinson's Disease), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07097103 nanot yet recruitingnot on this map

A 2x2 Factorial Randomized Controlled Non-pharmacological Interventional Multicenter Pilot Study on the Influence of the Mediterranean Diet and Physical Exercise on the Microbiome of Patients With Parkinson's Disease

TypeinterventionalSponsorIRCCS San Raffaele RomaRan2026 to 2029Enrolled80ConditionsParkinson&#39, s Disease (PD)ArmsMediterranean Diet Intervention, Intensive Physical Activity Intervention, Control
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Alice FognaniDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.
Rossella RotondoDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.
Maria Luisa Savo SardaroDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.
Antonio de IureDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.
Maria GaglioneIRCCS San Raffaele Roma, Cassino, Italy.
Miriam CasaliIRCCS San Raffaele Roma, Rome, Italy.
Lorenza LeonardiIRCCS San Raffaele Roma, Cassino, Italy.
Fabiana Giada RadicatiIRCCS San Raffaele Roma, Rome, Italy.
Laura VaccaIRCCS San Raffaele Roma, Rome, Italy.
Michele GuesciniDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.
Sabrina Donati ZeppaDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.
Lucia GattaScientific Direction, IRCCS San Raffaele Roma, Rome, Italy.
Fabrizio StocchiDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.
Barbara PicconiDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.
Maria Francesca De PandisDepartment for the Promotion of Human Science and Quality of Life, San Raffaele University, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and aims: Parkinson's disease (PD) is a neurodegenerative disorder for which no disease-modifying therapy currently exists, making it crucial to investigate alternative strategies that may slow its progression. The PRIME study will investigate the effects of combined dietary and physical activity interventions- performed in rehabilitative settings with health professional supervision and evaluation, versus single interventions on the gut microbiome in PD. The aim is to identify microbiome profiles - comparing traditional 16s rRNA gene sequencing with the third-generation method - as potential non-invasive, stage specific biomarkers of PD. In addition, the study will assess whether the combined intervention affects disease progression, symptoms, cognitive abilities, and quality of life. Methods: Eighty participants with PD will be randomized into four arms: a Mediterranean-diet intervention group; a structured physical-activity group; a combination group receiving both dietary and exercise interventions; a control group receiving standard care only. Conclusion: By integrating microbiome characterization with the evaluation of these interventions, the study aims to explore whether intervention-induced changes in the microbiota are associated with clinical improvement in PD, thus paving the way for the design of future non-pharmacological protocols to slow disease progression, mitigate symptom severity, and promote diagnosis. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT07097103.

Indexed as

Mediterranean dietmicrobiomeParkinson’s diseasePD biomarkersphysical activitypilot studystudy protocol

Identifiers

PMID41959663
PMCPMC13057374

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.