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,...
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| Veröffentlicht in: | Nutrients 2023-08, Vol.15 (16), p.3516 |
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| creator | Rondanelli, Mariangela Perna, Simone Della Porta, Matteo Lombardoni, Federico Patelli, Zaira Nichetti, Mara Gasparri, Clara Pistolesi, Elvira Cestaro, Benvenuto Cazzola, Roberta |
| description | 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. |
| doi_str_mv | 10.3390/nu15163516 |
| format | Article |
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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.</description><identifier>ISSN: 2072-6643</identifier><identifier>EISSN: 2072-6643</identifier><identifier>DOI: 10.3390/nu15163516</identifier><identifier>PMID: 37630707</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>Binge eating ; Body composition ; Body mass index ; Cardiovascular diseases ; Clinical trials ; Diet ; Disease ; Double-blind studies ; Drugs ; Eating disorders ; Energy ; Exercise ; Gastrointestinal surgery ; Gastrointestinal system ; Insulin resistance ; Intervention ; Liraglutide ; Medical equipment ; Medical technology ; Obesity ; Overweight ; Physical fitness ; Physiological apparatus ; Polymers ; Psychotropic drugs ; Type 2 diabetes ; Weight control</subject><ispartof>Nutrients, 2023-08, Vol.15 (16), p.3516</ispartof><rights>COPYRIGHT 2023 MDPI AG</rights><rights>2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2023 by the authors. 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c410t-b20e4484543f6227fbff3ca32dbc48e40dcd0eb04c53fe47144ffe9c48bc330a3</cites><orcidid>0000-0002-1984-1614 ; 0000-0002-2720-1473 ; 0000-0002-1088-6648 ; 0000-0001-8336-4851 ; 0000-0002-0778-8529</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10459239/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10459239/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27903,27904,53769,53771</link.rule.ids></links><search><creatorcontrib>Rondanelli, Mariangela</creatorcontrib><creatorcontrib>Perna, Simone</creatorcontrib><creatorcontrib>Della Porta, Matteo</creatorcontrib><creatorcontrib>Lombardoni, Federico</creatorcontrib><creatorcontrib>Patelli, Zaira</creatorcontrib><creatorcontrib>Nichetti, Mara</creatorcontrib><creatorcontrib>Gasparri, Clara</creatorcontrib><creatorcontrib>Pistolesi, Elvira</creatorcontrib><creatorcontrib>Cestaro, Benvenuto</creatorcontrib><creatorcontrib>Cazzola, Roberta</creatorcontrib><title>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</title><title>Nutrients</title><description>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.</description><subject>Binge eating</subject><subject>Body composition</subject><subject>Body mass index</subject><subject>Cardiovascular diseases</subject><subject>Clinical trials</subject><subject>Diet</subject><subject>Disease</subject><subject>Double-blind studies</subject><subject>Drugs</subject><subject>Eating disorders</subject><subject>Energy</subject><subject>Exercise</subject><subject>Gastrointestinal surgery</subject><subject>Gastrointestinal system</subject><subject>Insulin resistance</subject><subject>Intervention</subject><subject>Liraglutide</subject><subject>Medical equipment</subject><subject>Medical technology</subject><subject>Obesity</subject><subject>Overweight</subject><subject>Physical fitness</subject><subject>Physiological apparatus</subject><subject>Polymers</subject><subject>Psychotropic drugs</subject><subject>Type 2 diabetes</subject><subject>Weight control</subject><issn>2072-6643</issn><issn>2072-6643</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNptUt1uFCEUnhiNbWpvfAISb4zJVAaYn70y63ZtTdZsYzVeEmAOu2wYWIdhm_XRfLoyu421RgiBw_dzOORk2esCX1A6we9dLMqiomk9y04JrkleVYw-_-t8kp2HsMHjqHFd0ZfZCU3bGJxmv6foq3Ct78wvaNGlj9JC_tEa16IbKxRIn8-8G3pvbcJnCTBKWHQ7xHaPBo_mO2GjGAANa0BzrUENyLtD9APMap0ijQT6Au1Bdwk7owDdmWGNbrzdr2xUPojOOECLoiDIuMS-6n3cjsLlDvq7o016JFpKCIBuo9ykNOFV9kILG-D8YT_Lvn-af5td54vl1efZdJErVuAhlwQDYw0rGdUVIbWWWlMlKGmlYg0w3KoWg8RMlVQDqwvGUhmThElFKRb0LPtw9N1G2UGrIH2HsHzbm070e-6F4U8RZ9Z85Xe8wKycEDpJDm8fHHr_M0IYeGeCAmuFAx8DJ01ZN6ypWJWob_6hbnzsXarvwGJ4Qil5ZK2EBW6c9imxGk35tK4Ia1JSllgX_2Gl2UJnlHegTbp_Inh3FKjeh9CD_lNkgfnYbfyx2-g9lxrF_Q</recordid><startdate>20230801</startdate><enddate>20230801</enddate><creator>Rondanelli, Mariangela</creator><creator>Perna, Simone</creator><creator>Della Porta, Matteo</creator><creator>Lombardoni, Federico</creator><creator>Patelli, Zaira</creator><creator>Nichetti, Mara</creator><creator>Gasparri, Clara</creator><creator>Pistolesi, Elvira</creator><creator>Cestaro, Benvenuto</creator><creator>Cazzola, Roberta</creator><general>MDPI AG</general><general>MDPI</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1984-1614</orcidid><orcidid>https://orcid.org/0000-0002-2720-1473</orcidid><orcidid>https://orcid.org/0000-0002-1088-6648</orcidid><orcidid>https://orcid.org/0000-0001-8336-4851</orcidid><orcidid>https://orcid.org/0000-0002-0778-8529</orcidid></search><sort><creationdate>20230801</creationdate><title>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</title><author>Rondanelli, Mariangela ; Perna, Simone ; Della Porta, Matteo ; Lombardoni, Federico ; Patelli, Zaira ; Nichetti, Mara ; Gasparri, Clara ; Pistolesi, Elvira ; Cestaro, Benvenuto ; Cazzola, Roberta</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-b20e4484543f6227fbff3ca32dbc48e40dcd0eb04c53fe47144ffe9c48bc330a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Binge eating</topic><topic>Body composition</topic><topic>Body mass index</topic><topic>Cardiovascular diseases</topic><topic>Clinical trials</topic><topic>Diet</topic><topic>Disease</topic><topic>Double-blind studies</topic><topic>Drugs</topic><topic>Eating disorders</topic><topic>Energy</topic><topic>Exercise</topic><topic>Gastrointestinal surgery</topic><topic>Gastrointestinal system</topic><topic>Insulin resistance</topic><topic>Intervention</topic><topic>Liraglutide</topic><topic>Medical equipment</topic><topic>Medical technology</topic><topic>Obesity</topic><topic>Overweight</topic><topic>Physical fitness</topic><topic>Physiological apparatus</topic><topic>Polymers</topic><topic>Psychotropic drugs</topic><topic>Type 2 diabetes</topic><topic>Weight control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rondanelli, Mariangela</creatorcontrib><creatorcontrib>Perna, Simone</creatorcontrib><creatorcontrib>Della Porta, Matteo</creatorcontrib><creatorcontrib>Lombardoni, Federico</creatorcontrib><creatorcontrib>Patelli, Zaira</creatorcontrib><creatorcontrib>Nichetti, Mara</creatorcontrib><creatorcontrib>Gasparri, Clara</creatorcontrib><creatorcontrib>Pistolesi, Elvira</creatorcontrib><creatorcontrib>Cestaro, Benvenuto</creatorcontrib><creatorcontrib>Cazzola, Roberta</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Nutrients</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rondanelli, Mariangela</au><au>Perna, Simone</au><au>Della Porta, Matteo</au><au>Lombardoni, Federico</au><au>Patelli, Zaira</au><au>Nichetti, Mara</au><au>Gasparri, Clara</au><au>Pistolesi, Elvira</au><au>Cestaro, Benvenuto</au><au>Cazzola, Roberta</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Nutrients</jtitle><date>2023-08-01</date><risdate>2023</risdate><volume>15</volume><issue>16</issue><spage>3516</spage><pages>3516-</pages><issn>2072-6643</issn><eissn>2072-6643</eissn><abstract>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.</abstract><cop>Basel</cop><pub>MDPI AG</pub><pmid>37630707</pmid><doi>10.3390/nu15163516</doi><orcidid>https://orcid.org/0000-0002-1984-1614</orcidid><orcidid>https://orcid.org/0000-0002-2720-1473</orcidid><orcidid>https://orcid.org/0000-0002-1088-6648</orcidid><orcidid>https://orcid.org/0000-0001-8336-4851</orcidid><orcidid>https://orcid.org/0000-0002-0778-8529</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Binge eating Body composition Body mass index Cardiovascular diseases Clinical trials Diet Disease Double-blind studies Drugs Eating disorders Energy Exercise Gastrointestinal surgery Gastrointestinal system Insulin resistance Intervention Liraglutide Medical equipment Medical technology Obesity Overweight Physical fitness Physiological apparatus Polymers Psychotropic drugs Type 2 diabetes Weight control |
| title | 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 |
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