Search

Objective Intake of whole grains is associated with a reduced risk of cardiovascular disease (CVD). This evidence is also strong for bran alone, but findings about germ are conflicting. Our aim was to elucidate the role of germ in primary prevention of cardiovascular events, and therefore, a staple food was selected for 6 g of germ supplementation. This corresponds to sixfold increase in the global mean consumption of germ, while preserving the sensory proprieties of refined bread which is crucial for consumer's acceptance. Design Randomised, double-blinded, crossover, controlled clinical trial with 15-week follow-up comprising a 2-week run-in, two intervention periods of 4 weeks each and a 5-week washout period. Setting A single centre in the north of Portugal. Participants 55 eligible healthy adults (mean age of 34 years and body mass index between 19 and 38 kg/m2) were randomly assigned. Interventions The study consisted of two intervention periods including daily intake of refined wheat bread enriched with 6 g of wheat germ and control (non-enriched bread). Outcomes Changes in fasting cholesterol and triglycerides, fasting and postprandial glucose, insulin sensitivity and C reactive protein. Results We observed no significant effect of daily intake of wheat germ on cholesterol and triglycerides levels, on postprandial glucose response and on insulin sensitivity. Incremental area under curve glucose and homeostasis model assessment for insulin resistance did not change, suggesting that 6 g of wheat germ have no effect on glucose metabolism. No effect was also observed in the subgroup of participants who complied with the protocol (n=47). Conclusions The absence of alterations on lipid and glucose profiles suggests that germ up to 6 g/day may have no preventive effect on CVD risk. However, it is important to investigate other food vehicles that can accommodate higher doses of wheat germ in future studies. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]