Effects of an intervention with EVOO and physical exercise in systemic lupus erythematosus patients: Efinutriles trial protocol.

Background: Health-related lifestyle management could improve related symptoms and adverse events in patients with systemic lupus erythematosus (SLE). The phenolic compounds in extra virgin olive oil (EVOO) and physical exercise (PE) have both shown benefits for autoimmune conditions, but no intervention has synergised the two approaches.

Aim: To analyse the effects of an intervention combining EVOO and a multicomponent health promotion and physical exercise programme on disease activity, clinical characteristics, cardiovascular risk, physical fitness, and the molecular level in SLE sufferers.

Methods: Three-arm prospective randomised controlled 24-week clinical trial. 90 participants will be randomised into one of three groups: control; EVOO supplements; or EVOO and multicomponent health promotion and PE programme.

Results: Pre-, mid- and post-intervention assessments will record disease activity, clinical characteristics, nutritional evaluation, cardiovascular risk assessment, physical condition and functioning, and molecular markers.

Conclusions: The proposed trial will help clarify whether a combined intervention adding an EVOO supplement to a Mediterranean diet intake pattern and adherence to an active-healthy lifestyle are beneficial for SLE patients, as well as the need for health and pharmacological care, increasing knowledge of the organic mechanisms mediated by EVOO and PE adherence, allowing new useful biomarkers to be characterised at the diagnostic/prognostic level.