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.
Background. Overweight and obesity have reached epidemic proportions and safe treatments are needed to heal these diseases. Objective. The 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,...
| Publicado en: | Nutrients Vol. 15; no. 16; pp. 3516 - 3527 |
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| Autores principales: | , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
MDPI
Aug2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=170737685&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 170737685 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 20726643 B0TT jtl: Nutrients issn: 20726643 maglogo: N pubinfo: dt: Aug2023 vid: 15 iid: 16 pid: 97109 pub: MDPI artinfo: ui: 170737685 170737685 170737685 10.3390/nu15163516 170737685 ppf: 3516 ppct: 11 formats: tig: atl: 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. aug: au: Rondanelli, Mariangela Perna, Simone Della Porta, Matteo Lombardoni, Federico Patelli, Zaira Nichetti, Mara Gasparri, Clara Pistolesi, Elvira Cestaro, Benvenuto Cazzola, Roberta affil: Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy sug: subj: Obesity Equipment and Supplies Weight Loss Drug Effects Glucosamine Pharmacodynamics Insulin Resistance Vitamins Blood Glucosamine Blood Treatment Outcomes Human Randomized Controlled Trials Double-Blind Studies Comparative Studies Cholesterol Descriptive Statistics Random Assignment Funding Source ab: Background. Overweight and obesity have reached epidemic proportions and safe treatments are needed to heal these diseases. Objective. The 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. Methods. A 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. Results. One 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, D3, K1) and glucosamine levels was shown. Total cholesterol levels were significantly more reduced in the PG group compared to the PL group as it was for subjects with a BW decrease of >5%. Conclusions. PG 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. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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