Evidence map›Paper›PMID 37630707›Full record

Trial reportNutrients2023

A Randomized Double-Blind Placebo-Controlled Clinical Study to Evaluate the Effect on the Weight of a Medical Device with Polyglucosamine L112 in a Group of Overweight and Obese Subjects.

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

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 20% of its field
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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
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 at 2 institutions in 1 country.

Mariangela RondanelliDepartment of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy.ORCID 0000-0001-8336-4851
Simone PernaDivision of Human Nutrition, Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milano, Italy.ORCID 0000-0002-2720-1473
Matteo Della PortaDepartment of Biomedical and Clinical Sciences, University of Milano, 20157 Milano, Italy.ORCID 0000-0002-1984-1614
Federico LombardoniDepartment of Biomedical and Clinical Sciences, University of Milano, 20157 Milano, Italy.
Zaira PatelliEndocrinology and Nutrition Unit, Azienda di Servizi alla Persona "Istituto Santa Margherita", University of Pavia, 27100 Pavia, Italy.
Mara NichettiEndocrinology and Nutrition Unit, Azienda di Servizi alla Persona "Istituto Santa Margherita", University of Pavia, 27100 Pavia, Italy.
Clara GasparriEndocrinology and Nutrition Unit, Azienda di Servizi alla Persona "Istituto Santa Margherita", University of Pavia, 27100 Pavia, Italy.ORCID 0000-0002-1088-6648
Elvira PistolesiPostgraduate Course in Nutritional Food and Applied Nutrition, University of Milano, 20157 Milano, Italy.
Benvenuto CestaroPostgraduate Course in Nutritional Food and Applied Nutrition, University of Milano, 20157 Milano, Italy.
Roberta CazzolaDepartment of Biomedical and Clinical Sciences, University of Milano, 20157 Milano, Italy.ORCID 0000-0002-0778-8529
University of Milan · ITUniversity of Pavia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOverweight and obesity have reached epidemic proportions and safe treatments are needed to heal these diseases.

objectiveThe objective of this study is to examine the activity of a medical device based on polyglucosamine polymers (PG) on body weight (BW) reduction, insulin resistance, and the serum levels of fat-soluble vitamins and glucosamine.

methodsA double-blind placebo-controlled interventional study comparing PG and a placebo (PL) was conducted. One hundred and fifty overweight or obese cases were treated, divided into two groups for a period of 90 days at the dosage of 3 g/day.

resultsOne hundred and nineteen cases (58 with PG and 61 with PL, respectively) concluded the treatment. PG was more effective than the PL on the reduction of BW and insulin resistance. No modification of fat-soluble vitamins (Vit A, E, D

conclusionsPG acts as a safe medical device, is not absorbed, and binds lipids in the upper gastrointestinal tract, reducing their availability, with a significant activity on the reduction of BW, insulin resistance, and cholesterol levels without the modification of fat-soluble vitamins.

Indexed as

Insulin ResistanceOverweightCholesterolGlucosamineHumansObesityVitaminsWeight LossCholesterolGlucosamineVitaminsbody weightcholesterol levelsfat-soluble vitaminsglucosamineinsulin resistancepolyglucosamine L112

Identifiers

PMID37630707
PMCPMC10459239
OpenAlexW4385737999

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.