2.1. Design
inflammation
INFLAMMATION
To evaluate the effect of breakfast fat composition on cytokine and other inflammation-related factors, a prospective, randomized cross-over trial was conducted. The design employed in the present research, which focused on modifying breakfast to enhance cardiovascular health within a controlled setting, stands out as particularly robust due to its adept handling of confounding factors. By conducting the study within a controlled setting, the work gained a level of control over various environmental variables that could otherwise introduce noise and uncertainty into the results. This setting enables the attenuation of potential confounders, such as dietary habits influenced by communal lifestyle factors, and consistent adherence to a shared routine. Consequently, the findings are poised to provide a clearer and more accurate reflection of the impact of a modified breakfast on inflammation markers, bolstering the internal validity of the present research.Participants received three different breakfasts: a high-PUFA breakfast (B1: containing 20 g of margarine with no trans fatty acids), a high-SFA breakfast (B2: containing 20 g of butter), and a high-MUFA breakfast (B3: containing 20 g of virgin olive oil). Detailed nutrient analysis of the three breakfasts is provided in The researchers provided the breakfasts to the participants for 30 consecutive days. Subsequently, a 45-day washing-out period was implemented. The subjects were randomized to partake of one of the three breakfasts, and the type of intervention was alternated, according to a Latin square sequence. The randomization was carried out with the assistance of the Microsoft ExcelAfter obtaining authorization from the Ethics Committee of the Catholic University of Murcia (N # 1874), the patients were informed both verbally and in writing about the study’s design and purpose. They were also provided with an explanation of the ethical aspects of the project, including the main study objective and assurances of their ability to withdraw from the study at any time. Anonymity and the confidentiality of data were also guaranteed. The study adhered to the ethical principles outlined in the Declaration of Helsinki and Spanish legislation on biomedical research. Signing the informed consent was a prerequisite for participation. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN) under number #12611000456954 (detailed information available at: 