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The impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery — study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trial

2023-05Artigo científico Acesso aberto
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dc.contributor.authorIsmael, Shámila
dc.contributor.authorVaz, Carlos
dc.contributor.authorDurão, Catarina
dc.contributor.authorSilvestre, Marta P.
dc.contributor.authorCalhau, Conceição
dc.contributor.authorCalhau, Conceição
dc.contributor.authorTeixeira, Diana
dc.contributor.authorMarques, Cláudia
dc.contributor.institutionNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
dc.contributor.institutionComprehensive Health Research Centre (CHRC) - pólo NMS
dc.contributor.institutionCentro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS)
dc.contributor.pblBioMed Central (BMC)
dc.date.accessioned2023-06-05T22:21:07Z
dc.date.available2023-06-05T22:21:07Z
dc.date.issued2023-05
dc.descriptionFunding Information: This project has not received direct funding and is supported within the scope of other projects. This support source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. This work is supported by ERDF through the operation POCI-01–0145-ERDF-007746 funded by the Programa Operacional Competitividade e Internacionalização – COMPETE2020 and is financed by FCT—Fundação para a Ciência e a Tecnologia, I.P., through CINTESIS, R&D Unit (UIDB/4255/2020), CHRC (UIDP/04923/2020 and UIDB/04923/2020), and through the project 2020.06333.BD. This study is also supported by Projetos de investigação clínica 2021 grant from the Academia CUF. Publisher Copyright: © 2023, The Author(s).
dc.description.abstractBackground: Subjects with obesity exhibit changes in gut microbiota composition and function (i.e. dysbiosis) that contribute to metabolic dysfunction, including appetite impairment. Although bariatric surgery is an effective treatment for obesity with a great impact on weight loss, some subjects show weight regain due to increased energy intake after the surgery. This surgery involves gut microbiota changes that promote appetite control, but it seems insufficient to completely restore the obesity-associated dysbiosis — a possible contributor for weight regain. Thus, modulating gut microbiota with probiotics that could improve appetite regulation as a complementary approach to post-operative diet (i.e. Hafnia alvei HA4597™), may accentuate post-surgery weight loss and insulin sensitivity. Methods: This is a protocol of a triple-blinded, blocked-randomized, parallel-group, placebo-controlled clinical trial designed to determine the effect of Hafnia alvei HA4597™ supplementation on weight loss and glycaemic control 1 year after bariatric surgery. Patients of Hospital CUF Tejo, Lisbon, that undergo Roux-en-Y gastric bypass are invited to participate in this study. Men and women between 18 and 65 years old, with a BMI ≥ 35 kg/m2 and at least one severe obesity-related comorbidity, or with a BMI ≥ 40 kg/m2, and who are willing to take 2 capsules of Hafnia alvei HA4597™ probiotic supplements (equivalent to 5 × 107 CFU) vs. placebo per day for 90 days are included in this study. Assessments are carried out at baseline, 3, 6, 9, and 12 months after the surgery. Loss of weight in excess and glycated haemoglobin are considered primary outcomes. In addition, changes in other metabolic and inflammatory outcomes, gut microbiota composition and metabolites, as well as gastrointestinal quality of life are also being assessed during the trial. Discussion: The evidence obtained in this study will provide relevant information regarding the profile of the intestinal microbiota of individuals with severe obesity and the identification of the risk/benefit ratio of the use of Hafnia alvei HA4597™ as an adjunctive treatment in the maintenance of metabolic and weight control one year after the surgical intervention. Trial registration: ClinicalTrials.gov NCT05170867. Registered on 28 December 2021.en
dc.description.versionpublishersversion
dc.description.versionpublished
dc.format.extent2893717
dc.identifier.doi10.1186/s13063-023-07383-0
dc.identifier.issn1745-6215
dc.identifier.otherPURE: 62792075
dc.identifier.otherPURE UUID: 1cfef3f9-fe69-4206-a8f2-8f43369f652b
dc.identifier.otherScopus: 85160224078
dc.identifier.otherPubMed: 37248499
dc.identifier.otherORCID: /0000-0001-9327-2897/work/151404641
dc.identifier.urihttp://hdl.handle.net/10362/153628
dc.identifier.urlhttps://www.scopus.com/pages/publications/85160224078
dc.language.isoeng
dc.peerreviewedyes
dc.subjectBariatric surgery
dc.subjectGlycaemic control
dc.subjectHafnia alvei HA4597™
dc.subjectObesity
dc.subjectWeight loss
dc.subjectMedicine (miscellaneous)
dc.subjectPharmacology (medical)
dc.subjectSDG 3 - Good Health and Well-being
dc.titleThe impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery — study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trialen
dc.typejournal article
degois.publication.issue1
degois.publication.titleTrials
degois.publication.volume24
dspace.entity.typePublication
person.familyNameCalhau
person.givenNameConceição
person.identifier.ciencia-id2110-0420-1717
person.identifier.orcid0000-0001-9567-3379
person.identifier.scopus-author-id6701578877
rcaap.rightsopenAccess
relation.isAuthorOfPublication32b016c8-810a-40be-b9ee-ddfb07668a78
relation.isAuthorOfPublication.latestForDiscovery32b016c8-810a-40be-b9ee-ddfb07668a78

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