Evidence map›Paper›PMID 40898346›Full record

ArticleBMC nutrition2025

Modification of metabolic syndrome parameters following the administration of polyglucosamine L112: results of a subgroup analysis of subjects enrolled in a double blind randomised placebo controlled clinical investigation.

Mariangela Rondanelli, Simone Perna, Matteo Della Porta, Federico Lombardoni, Zaira Patelli, Mara Nichetti, Clara Gasparri, Elvira Pistolesi, Benvenuto Cestaro, Roberta Cazzola

Registry-linked trialAbstract read
In one paragraph

Article in BMC nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04375696 (Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects), which is not on this 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.

NCT04375696 phase4completednot on this map

Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects: POSO Study (Polyglucosamine and Overweight)

TypeinterventionalSponsorCertmedica International GmbHRan2020 to 2021Enrolled150ConditionsWeight LossArmsPolyglucosamine L112, Placebo
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

10 authors.

Mariangela RondanelliDepartment of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, 27100, Italy.
Simone PernaDivision of Human Nutrition, Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milano, Milano, 20133, Italy.
Matteo Della PortaDepartment of Biomedical and Clinical Sciences, University of Milano, Milano, 20157, Italy.
Federico LombardoniDepartment of Biomedical and Clinical Sciences, University of Milano, Milano, 20157, Italy.
Zaira PatelliEndocrinology and Nutrition Unit, Azienda di Servizi alla Persona "Istituto Santa Margherita", University of Pavia, Pavia, 27100, Italy.
Mara NichettiEndocrinology and Nutrition Unit, Azienda di Servizi alla Persona "Istituto Santa Margherita", University of Pavia, Pavia, 27100, Italy.
Clara GasparriEndocrinology and Nutrition Unit, Azienda di Servizi alla Persona "Istituto Santa Margherita", University of Pavia, Pavia, 27100, Italy. clara.gasparri01@universitadipavia.it.
Elvira PistolesiPostgraduate Course in Nutritional Food and Applied Nutrition, University of Milano, Milano, 20157, Italy.
Benvenuto CestaroPostgraduate Course in Nutritional Food and Applied Nutrition, University of Milano, Milano, 20157, Italy.
Roberta CazzolaDepartment of Biomedical and Clinical Sciences, University of Milano, Milano, 20157, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUp to now, scientific literature has not reported studies evaluating the efficacy of polyglucosamine L112 on body weight, insulin resistance, and cholesterol levels in patients with metabolic syndrome, despite its known antioxidant properties and potential to reduce these parameters, making it a promising candidate for treating metabolic syndrome.

objectiveThe aim of this study was to examine the activity of L112 in a subgroup of cases suffering from metabolic syndrome (MS).

methodsA subgroup of 26 subjects (8 males and 18 females; age 55 ± 11.3 years; BMI 31.1 ± 1.35 kg/m²) was selected from a previous larger RCT study and statistically analyzed. Among them, 12 subjects were administered a diet and placebo, while 14 were administered a diet and L112 at a dosage of 3 g/day.

resultsIn the placebo group, 3 out of 12 cases (25%) showed resolution of metabolic syndrome (MS), whereas in the L112 group, 7 out of 14 cases (50%) showed resolution. Differences were statistically significant (Fisher χ

conclusionsDespite a relatively short period of administration (3 months), L112 was found to reduce MS in 50% of the cases, acting as a safe medical device as a single daily treatment.

trial registrationCurrent Controlled Trials NCT04375696, 20/12/2021 (https//clinicaltrials.gov/study/NCT04375696), "Retrospectively registered".

Indexed as

Fat massFat-soluble vitaminsInsulin resistanceMetabolic syndromePolyglucosamine L112Visceral adipose tissue

Identifiers

PMID40898346
PMCPMC12403585

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 OpenQuestion graph.