The objective was to investigate the effects of substitution (SUB) dietary guidelines (DG) targeted at the prevention of IHD on dietary intake and IHD risk factors in Danish adults with minimum one self-assessed IHD risk factor. A 6-month single-blinded parallel randomised controlled trial with a follow-up at month 12 included 219 subjects (median age 51 years, 59 % female, 73 % overweight or obese) randomised into an SUB DG, an official (OFF) DG or a control group following their habitual diet (HAB). Participants in the DG intervention groups received bi-weekly reminders of their DG and recipes for dishes and the HAB group received a greeting. Dietary intake and fasting blood, anthropometric and blood pressure measurements were obtained at baseline, month 6 and month 12. Linear regression analyses were applied. At month 6, when compared with the HAB, the SUB had a greater impact on the extent of dietary changes with increased intake of whole grains, dietary fibre and low fibre vegetables compared with the OFF DG, and both DG groups had similar decreased percentage of energy (E%) intake from SFA. The extent of dietary changes was similar at month 12. No overall significant changes from baseline were found in blood pressure, anthropometrics and IHD risk markers. In conclusion, both SUB and OFF DG resulted in cardioprotective dietary changes. However, neither the SUB nor the OFF DG resulted in any overall effects on the selected intermediate risk factors for IHD.

Background Peristomal skin complications (PSCs) are the most predominant complication for people living with a stoma negatively affecting the health-related quality of life (QoL). PSCs may also have an impact on healthcare costs for the society with more visits to healthcare professionals and increased consumption of products and treatment strategies which amplifies the need for new strategies to reduce or prevent PSCs. Aim To evaluate the performance of an ostomy baseplate with a skin protection technology. The target group was people living with a stoma with liquid faecal effluent, who struggled with PSCs. Design and methods A randomized, controlled, open-labeled, cross-over trial conducted from September 2021 to February 2022 in five different countries. Each participant tested the investigational product against a comparator product (SenSura® Mio). The Ostomy Skin Tool 2.0 was used to evaluate the peristomal skin and health-related QoL was measured using the Dermatology Life Quality Index (DLQI) questionnaire. Data were analysed in mixed repeated measures models. Results A total of 79 adult participants (mean age 54.5 years, female 45.6%) were included in the intention-to-treat (ITT) population. A significant reduction in PSCs (p = 0.015) and health-related QoL (p = 0.035) was found for the investigational product when compared to the comparator product. Also, significantly more study participants preferred the investigational product when compared to the comparator product (p = 0.017) Conclusion The investigational product; an ostomy baseplate with a skin protective technology reduced PSCs and improved health-related QoL of people living with a stoma with liquid faecal effluent. Consequently, the investigational product was the preferred ostomy appliance by the participants. Thus, the product investigated in this study may be a new solution to be included in everyday clinical practice to overcome leakage-induced PSCs for people living with a stoma.