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Abstract
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.
Trial registration number NCT02405507; pre-results.
- wheat germ
- health claims
- randomized controlled trial
- cardiovascular risk
- gastrointestinal discomfort
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors AMR was partially responsible for study design, statistical analysis plan, carrying out the trial, protocol manuscript writing and final revision. HP was partially responsible for study design, carrying out the trial, manuscript writing and final revision. CC was responsible for the general coordination of the project, study design, protocol manuscript writing and final revision. LFA was responsible for the general coordination of the project, study design, statistical analysis plan, protocol manuscript writing and final revision.
Funding This work was supported by FEDER through the operations FCOMP-01-0202-FEDER-038861 and POCI-01-0145-FEDER-007746 funded by the Programa Operacional Competitividade e Internacionalização – COMPETE2020 and by National Funds through FCT - Fundação para a Ciência e a Tecnologia within CINTESIS, R&D Unit (reference UID/IC/4255/2013).
Disclaimer The funder had no role in study design and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Competing interests None declared.
Ethics approval Health Ethics Committee of São João Hospital Centre (reference 156-15) and the Ethics Committee of the Faculty of Medicine of the University of Porto (reference PCEDCSS-FMUP 07/2015).
Provenance and peer review Not commissioned; externally peer reviewed.