Intervention design and adherence to Mediterranean diet in the Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat (CADIMED) randomized trial

Abstract

Effective interventions targeting modifiable cardiovascular disease (CVD) risk factors, such as diet, are urgently needed. The Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat (CADIMED) study hypothesizes that eliminating red and processed meat in the context of a Mediterranean diet (MD) will significantly modify circulating low-density lipoprotein cholesterol (LDL-C) concentration and the fatty acid profile compared to general CVD prevention advice. Here we describe the intervention design and summarize baseline dietary intakes (mean±SD) related to MD adherence and red/processed meat intakes in a sample of 81 participants. The CADIMED study is a two-arm, 8-week parallel randomized controlled intervention trial involving a final sample of 156 adults (≥18 years) with dyslipidemia (not undergoing pharmacological treatment) recruited from healthcare and community settings in Granada (Spain). The primary outcome will assess changes in circulating LDL-C and the fatty acid profile, whilst secondary outcomes will measure changes in CVD-related metabolites/biomarkers, gut microbiome, diet/lifestyle and intervention feasibility/acceptability. Preliminary findings indicate low MD adherence (Mediterranean Diet Adherence Screener score 7.6±1.9), and high consumption of red and processed meat (1.04±0.90) servings/day). These results underscore the need for targeted dietary interventions to address the growing burden of dyslipidemia and CVD. If successful, this intervention holds potential for scalability and significant impact on public health, dietary guidelines, and advancements in nutrition science by improving MD adherence and reducing CVD risk factors in adults with dyslipidemia. This trial was registered at clinicaltrials.gov (NCT05778656). Date: March 21, 2023.