Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis.
<h4>Background</h4>Multiple Sclerosis (MS) is the first cause of non-traumatic neurological disability in young adults. Primary and secondary progressive MS are still lacking effective treatments. A new nutraceutical product made of lyophilised leaves of bioengineered kiwi plants (Actini...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2025-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0311214 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850151445520711680 |
|---|---|
| author | Viola Costa Kenda Aluan Irene Schiavetti Caterina Bason Tiziana Vigo Elisa Leveraro Corrado Cabona Valeria Prada Mauro Costagli Vincenzo Daniele Boccia Bruno Ruggiero Giampaolo Brichetto Marco Salvetti Maria Pia Sormani Gianluigi Mancardi Matilde Inglese Mario Alberto Battaglia |
| author_facet | Viola Costa Kenda Aluan Irene Schiavetti Caterina Bason Tiziana Vigo Elisa Leveraro Corrado Cabona Valeria Prada Mauro Costagli Vincenzo Daniele Boccia Bruno Ruggiero Giampaolo Brichetto Marco Salvetti Maria Pia Sormani Gianluigi Mancardi Matilde Inglese Mario Alberto Battaglia |
| author_sort | Viola Costa |
| collection | DOAJ |
| description | <h4>Background</h4>Multiple Sclerosis (MS) is the first cause of non-traumatic neurological disability in young adults. Primary and secondary progressive MS are still lacking effective treatments. A new nutraceutical product made of lyophilised leaves of bioengineered kiwi plants (Actinidia deliciosa) overexpressing osmotin has recently been developed. Osmotin is a protein associated with stress adaptation in plant cells and it shares anti-inflammatory and neuroprotective properties with mammalian adiponectin. The aim of this study is to explore the safety and the efficacy of osmotin in progressive MS (PMS).<h4>Methods</h4>This is a prospective, multicenter, single-arm interventional, baseline vs treatment study that will be carried out by two Italian MS centers, where a total of fifty PMS patients will be recruited. Every patient will take a daily dosage of 5 grams of an osmotin-based nutraceutical, named Forza™ (9th Dimension Biotech, Inc.), for 6 months. Two pre-treatment assessments, at -6 months (-6M) and at baseline visit (M0), and two post-treatment assessments, at month 1 (M1), and at month 6 (M6) will be carried out. ForzaTM safety and activity, assessed by serum Neurofilaments Light (NfL) Chain quantification, are the primary outcomes of the study. Additional assessments will consist of clinical and neuropsychological evaluations, patient reported outcomes (PROs), brain magnetic resonance imaging (MRI), motor evoked potentials (MEPs) and optical coherence tomography (OCT).<h4>Discussion</h4>Disease modifying treatments in MS usually target inflammatory pathways with excellent results on reducing relapse associated disability but fail in preventing progression independent from relapse activity. This is a proof-of-concept study aimed at exploring the safety and the activity of an osmotin-based nutraceutical as an adjuvant treatment in PMS patients.<h4>Trial registration</h4>The trial was registered on July 10th 2023 at www.clinicaltrials.gov having identifier NCT05937802. |
| format | Article |
| id | doaj-art-b166c436eae5406ab1fd4a593c012919 |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-b166c436eae5406ab1fd4a593c0129192025-08-20T02:26:15ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01202e031121410.1371/journal.pone.0311214Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis.Viola CostaKenda AluanIrene SchiavettiCaterina BasonTiziana VigoElisa LeveraroCorrado CabonaValeria PradaMauro CostagliVincenzo Daniele BocciaBruno RuggieroGiampaolo BrichettoMarco SalvettiMaria Pia SormaniGianluigi MancardiMatilde IngleseMario Alberto Battaglia<h4>Background</h4>Multiple Sclerosis (MS) is the first cause of non-traumatic neurological disability in young adults. Primary and secondary progressive MS are still lacking effective treatments. A new nutraceutical product made of lyophilised leaves of bioengineered kiwi plants (Actinidia deliciosa) overexpressing osmotin has recently been developed. Osmotin is a protein associated with stress adaptation in plant cells and it shares anti-inflammatory and neuroprotective properties with mammalian adiponectin. The aim of this study is to explore the safety and the efficacy of osmotin in progressive MS (PMS).<h4>Methods</h4>This is a prospective, multicenter, single-arm interventional, baseline vs treatment study that will be carried out by two Italian MS centers, where a total of fifty PMS patients will be recruited. Every patient will take a daily dosage of 5 grams of an osmotin-based nutraceutical, named Forza™ (9th Dimension Biotech, Inc.), for 6 months. Two pre-treatment assessments, at -6 months (-6M) and at baseline visit (M0), and two post-treatment assessments, at month 1 (M1), and at month 6 (M6) will be carried out. ForzaTM safety and activity, assessed by serum Neurofilaments Light (NfL) Chain quantification, are the primary outcomes of the study. Additional assessments will consist of clinical and neuropsychological evaluations, patient reported outcomes (PROs), brain magnetic resonance imaging (MRI), motor evoked potentials (MEPs) and optical coherence tomography (OCT).<h4>Discussion</h4>Disease modifying treatments in MS usually target inflammatory pathways with excellent results on reducing relapse associated disability but fail in preventing progression independent from relapse activity. This is a proof-of-concept study aimed at exploring the safety and the activity of an osmotin-based nutraceutical as an adjuvant treatment in PMS patients.<h4>Trial registration</h4>The trial was registered on July 10th 2023 at www.clinicaltrials.gov having identifier NCT05937802.https://doi.org/10.1371/journal.pone.0311214 |
| spellingShingle | Viola Costa Kenda Aluan Irene Schiavetti Caterina Bason Tiziana Vigo Elisa Leveraro Corrado Cabona Valeria Prada Mauro Costagli Vincenzo Daniele Boccia Bruno Ruggiero Giampaolo Brichetto Marco Salvetti Maria Pia Sormani Gianluigi Mancardi Matilde Inglese Mario Alberto Battaglia Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis. PLoS ONE |
| title | Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis. |
| title_full | Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis. |
| title_fullStr | Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis. |
| title_full_unstemmed | Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis. |
| title_short | Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis. |
| title_sort | study protocol exploratory trial of forza™ an osmotin based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis |
| url | https://doi.org/10.1371/journal.pone.0311214 |
| work_keys_str_mv | AT violacosta studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT kendaaluan studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT ireneschiavetti studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT caterinabason studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT tizianavigo studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT elisaleveraro studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT corradocabona studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT valeriaprada studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT maurocostagli studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT vincenzodanieleboccia studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT brunoruggiero studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT giampaolobrichetto studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT marcosalvetti studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT mariapiasormani studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT gianluigimancardi studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT matildeinglese studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis AT marioalbertobattaglia studyprotocolexploratorytrialofforzaanosmotinbasednutraceuticalasadjuvantforthetreatmentofprogressivemultiplesclerosis |