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

Detalhes bibliográficos
Autor(a) principal: Ismael, Shámila
Data de Publicação: 2023
Outros Autores: Vaz, Carlos, Durão, Catarina, Silvestre, Marta P., Calhau, Conceição, Teixeira, Diana, Marques, Cláudia
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/153628
Resumo: Funding 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).
id RCAP_16143c640632b815dfc416d551c6b2b2
oai_identifier_str oai:run.unl.pt:10362/153628
network_acronym_str RCAP
network_name_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository_id_str 7160
spelling 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 trialBariatric surgeryGlycaemic controlHafnia alvei HA4597™ObesityWeight lossMedicine (miscellaneous)Pharmacology (medical)SDG 3 - Good Health and Well-beingFunding 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).Background: 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.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)Comprehensive Health Research Centre (CHRC) - pólo NMSCentro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS)RUNIsmael, ShámilaVaz, CarlosDurão, CatarinaSilvestre, Marta P.Calhau, ConceiçãoTeixeira, DianaMarques, Cláudia2023-06-05T22:21:07Z2023-052023-05-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/153628eng1745-6215PURE: 62792075https://doi.org/10.1186/s13063-023-07383-0info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:36:11Zoai:run.unl.pt:10362/153628Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:55:21.132258Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Ismael, Shámila
Bariatric surgery
Glycaemic control
Hafnia alvei HA4597™
Obesity
Weight loss
Medicine (miscellaneous)
Pharmacology (medical)
SDG 3 - Good Health and Well-being
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author Ismael, Shámila
author_facet Ismael, Shámila
Vaz, Carlos
Durão, Catarina
Silvestre, Marta P.
Calhau, Conceição
Teixeira, Diana
Marques, Cláudia
author_role author
author2 Vaz, Carlos
Durão, Catarina
Silvestre, Marta P.
Calhau, Conceição
Teixeira, Diana
Marques, Cláudia
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
Comprehensive Health Research Centre (CHRC) - pólo NMS
Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS)
RUN
dc.contributor.author.fl_str_mv Ismael, Shámila
Vaz, Carlos
Durão, Catarina
Silvestre, Marta P.
Calhau, Conceição
Teixeira, Diana
Marques, Cláudia
dc.subject.por.fl_str_mv Bariatric surgery
Glycaemic control
Hafnia alvei HA4597™
Obesity
Weight loss
Medicine (miscellaneous)
Pharmacology (medical)
SDG 3 - Good Health and Well-being
topic Bariatric surgery
Glycaemic control
Hafnia alvei HA4597™
Obesity
Weight loss
Medicine (miscellaneous)
Pharmacology (medical)
SDG 3 - Good Health and Well-being
description Funding 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).
publishDate 2023
dc.date.none.fl_str_mv 2023-06-05T22:21:07Z
2023-05
2023-05-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/153628
url http://hdl.handle.net/10362/153628
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1745-6215
PURE: 62792075
https://doi.org/10.1186/s13063-023-07383-0
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
_version_ 1799138140843147264

Registros relacionados