Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects

Detalhes bibliográficos
Autor(a) principal: Moreira-Rosário, A
Data de Publicação: 2016
Outros Autores: Pinheiro, H, Calhau, C, Azevedo, LF
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.17/2814
Resumo: INTRODUCTION: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now. Previous studies do not clarify the hypothesised potential causal relationship between the consumption of wheat germ and benefits for human health. METHODS AND ANALYSIS: We are conducting a randomised, double-blinded, crossover, placebo-controlled clinical trial designed to assess the physiological effects of daily consumption of wheat germ-enriched bread (containing 6 g of wheat germ) compared with non-enriched bread, over a 4-week period with a 15-week follow-up, in a healthy human population. A total of 55 participants (healthy volunteers, aged 18-60) have been recruited from the Porto metropolitan area in northern Portugal. Our aim is to evaluate the health effects of wheat germ on blood cholesterol and triglycerides, postprandial glycaemic response, gastrointestinal function and discomfort, and changes in intestinal microbiota and insulin resistance as secondary outcomes. The study follows the best practices for evaluating health claims in food according to the European Food Safety Authority (EFSA) scientific opinion, namely random allocation, double blinding, reporting methods to measure and maximise compliance, and validated outcomes with beneficial physiological effects as recommended by EFSA. ETHICS AND DISSEMINATION: The study has been approved by the Health Ethics Committee of São João Hospital Centre (156-15) and the Ethics Committee of Faculty of Medicine of the University of Porto (PCEDCSS-FMUP07/2015). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.
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spelling Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health EffectsHCC INFBlood Glucose/metabolismBreadCholesterol/bloodCross-Over StudiesDouble-Blind MethodFood, FortifiedGastrointestinal MicrobiomeHealthy DietHealthy VolunteersInsulin ResistancePortugalResearch DesignRisk FactorsSelf ReportTriglycerides/bloodTriticumINTRODUCTION: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now. Previous studies do not clarify the hypothesised potential causal relationship between the consumption of wheat germ and benefits for human health. METHODS AND ANALYSIS: We are conducting a randomised, double-blinded, crossover, placebo-controlled clinical trial designed to assess the physiological effects of daily consumption of wheat germ-enriched bread (containing 6 g of wheat germ) compared with non-enriched bread, over a 4-week period with a 15-week follow-up, in a healthy human population. A total of 55 participants (healthy volunteers, aged 18-60) have been recruited from the Porto metropolitan area in northern Portugal. Our aim is to evaluate the health effects of wheat germ on blood cholesterol and triglycerides, postprandial glycaemic response, gastrointestinal function and discomfort, and changes in intestinal microbiota and insulin resistance as secondary outcomes. The study follows the best practices for evaluating health claims in food according to the European Food Safety Authority (EFSA) scientific opinion, namely random allocation, double blinding, reporting methods to measure and maximise compliance, and validated outcomes with beneficial physiological effects as recommended by EFSA. ETHICS AND DISSEMINATION: The study has been approved by the Health Ethics Committee of São João Hospital Centre (156-15) and the Ethics Committee of Faculty of Medicine of the University of Porto (PCEDCSS-FMUP07/2015). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.BMJ Publishing GroupRepositório do Centro Hospitalar Universitário de Lisboa Central, EPEMoreira-Rosário, APinheiro, HCalhau, CAzevedo, LF2017-11-27T16:02:27Z2016-11-102016-11-10T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.17/2814engBMJ Open. 2016 Nov 10;6(11):e013098.10.1136/bmjopen-2016-013098info: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:RCAAP2023-03-10T09:39:45Zoai:repositorio.chlc.min-saude.pt:10400.17/2814Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T17:20:09.003679Repositório 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 Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
title Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
spellingShingle Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
Moreira-Rosário, A
HCC INF
Blood Glucose/metabolism
Bread
Cholesterol/blood
Cross-Over Studies
Double-Blind Method
Food, Fortified
Gastrointestinal Microbiome
Healthy Diet
Healthy Volunteers
Insulin Resistance
Portugal
Research Design
Risk Factors
Self Report
Triglycerides/blood
Triticum
title_short Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
title_full Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
title_fullStr Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
title_full_unstemmed Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
title_sort Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health Effects
author Moreira-Rosário, A
author_facet Moreira-Rosário, A
Pinheiro, H
Calhau, C
Azevedo, LF
author_role author
author2 Pinheiro, H
Calhau, C
Azevedo, LF
author2_role author
author
author
dc.contributor.none.fl_str_mv Repositório do Centro Hospitalar Universitário de Lisboa Central, EPE
dc.contributor.author.fl_str_mv Moreira-Rosário, A
Pinheiro, H
Calhau, C
Azevedo, LF
dc.subject.por.fl_str_mv HCC INF
Blood Glucose/metabolism
Bread
Cholesterol/blood
Cross-Over Studies
Double-Blind Method
Food, Fortified
Gastrointestinal Microbiome
Healthy Diet
Healthy Volunteers
Insulin Resistance
Portugal
Research Design
Risk Factors
Self Report
Triglycerides/blood
Triticum
topic HCC INF
Blood Glucose/metabolism
Bread
Cholesterol/blood
Cross-Over Studies
Double-Blind Method
Food, Fortified
Gastrointestinal Microbiome
Healthy Diet
Healthy Volunteers
Insulin Resistance
Portugal
Research Design
Risk Factors
Self Report
Triglycerides/blood
Triticum
description INTRODUCTION: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now. Previous studies do not clarify the hypothesised potential causal relationship between the consumption of wheat germ and benefits for human health. METHODS AND ANALYSIS: We are conducting a randomised, double-blinded, crossover, placebo-controlled clinical trial designed to assess the physiological effects of daily consumption of wheat germ-enriched bread (containing 6 g of wheat germ) compared with non-enriched bread, over a 4-week period with a 15-week follow-up, in a healthy human population. A total of 55 participants (healthy volunteers, aged 18-60) have been recruited from the Porto metropolitan area in northern Portugal. Our aim is to evaluate the health effects of wheat germ on blood cholesterol and triglycerides, postprandial glycaemic response, gastrointestinal function and discomfort, and changes in intestinal microbiota and insulin resistance as secondary outcomes. The study follows the best practices for evaluating health claims in food according to the European Food Safety Authority (EFSA) scientific opinion, namely random allocation, double blinding, reporting methods to measure and maximise compliance, and validated outcomes with beneficial physiological effects as recommended by EFSA. ETHICS AND DISSEMINATION: The study has been approved by the Health Ethics Committee of São João Hospital Centre (156-15) and the Ethics Committee of Faculty of Medicine of the University of Porto (PCEDCSS-FMUP07/2015). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.
publishDate 2016
dc.date.none.fl_str_mv 2016-11-10
2016-11-10T00:00:00Z
2017-11-27T16:02:27Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.17/2814
url http://hdl.handle.net/10400.17/2814
dc.language.iso.fl_str_mv eng
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dc.relation.none.fl_str_mv BMJ Open. 2016 Nov 10;6(11):e013098.
10.1136/bmjopen-2016-013098
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eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
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