Evidence map›Paper›PMID 42278649›Full record

Trial reportInternational journal of molecular sciences2026

Evaluating a Coenzyme Q10-Based Food for Special Medical Purpose, for Mitochondrial Diseases Management: An Open-Label, Pilot Trial.

Lucia Chico, Piervito Lopriore, Giulia Cecchi, Adriana Meli, Clara Bernardini, Linda Balestrini, Maico Polzella, Vincenzo Montano, Michelangelo Mancuso

Abstract readClinical Trial
In one paragraph

Trial report in International journal of molecular sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Lucia ChicoLaboratori Aliveda S.r.l., Crespina Lorenzana, 56042 Pisa, Italy.ORCID 0000-0001-5832-7098
Piervito LoprioreDepartment of Clinical and Experimental Medicine, Neurological Institute, University of Pisa, 56100 Pisa, Italy.
Giulia CecchiDepartment of Clinical and Experimental Medicine, Neurological Institute, University of Pisa, 56100 Pisa, Italy.
Adriana MeliDepartment of Clinical and Experimental Medicine, Neurological Institute, University of Pisa, 56100 Pisa, Italy.
Clara BernardiniDepartment of Clinical and Experimental Medicine, Neurological Institute, University of Pisa, 56100 Pisa, Italy.
Linda BalestriniLaboratori Aliveda S.r.l., Crespina Lorenzana, 56042 Pisa, Italy.
Maico PolzellaLaboratori Aliveda S.r.l., Crespina Lorenzana, 56042 Pisa, Italy.
Vincenzo MontanoDepartment of Clinical and Experimental Medicine, Neurological Institute, University of Pisa, 56100 Pisa, Italy.ORCID 0000-0002-7548-7699
Michelangelo MancusoDepartment of Clinical and Experimental Medicine, Neurological Institute, University of Pisa, 56100 Pisa, Italy.ORCID 0000-0003-2738-8562

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Primary mitochondrial diseases (PMD) are rare disorders with limited therapeutic options. Coenzyme Q10 (CoQ10) supplementation is widely used, although formulation differences can affect absorption and efficacy. This open-label pilot feasibility trial evaluated a food for special medical purposes (FSMP) containing high-dose CoQ10 (250 mg per capsule) in patients with PMD. Ten patients (mean age: 55.5 ± 8.6 years) were enrolled. Serum/plasma biomarkers, including CoQ10, fibroblast growth factor 21 (FGF21), growth differentiation factor 15 (GDF15), ferric-reducing antioxidant power (FRAP), total sulfhydryl groups (t-SH), and advanced oxidation protein products (AOPP), were assessed at baseline (T0, after ≥30 days of conventional ubidecarenone) and after 30 days of FSMP administration (T1). Fatigue severity scale (FSS) and 5-times sit-to-stand test (5xSST) were evaluated at both timepoints. FSMP was administered at 250 or 500 mg/day. Twenty sex- and age-matched healthy controls were included for CoQ10 comparison. Absolute CoQ10 concentrations remained stable overall at T1, with all patients maintaining levels above 390 ng/mL (100% vs. 60% at T0), although concentrations remained lower than in healthy controls (

Indexed as

Dietary SupplementsMitochondrial DiseasesUbiquinoneAdultAgedBiomarkersFemaleHumansMaleMiddle AgedPilot ProjectsBiomarkerscoenzyme Q10Ubiquinoneantioxidantscoenzyme Q10food for special medical purposesmitochondrial diseases

Identifiers

PMID42278649
PMCPMC13257338

What Socratic holds

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Registered trials

None linked

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.