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Updated: May 22, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
EFINUTRILES Study: Integrative Extra Virgin Olive Oil and Multimodal Lifestyle Interventions for Cardiovascular
Rocío Gil-Gutiérrez1,2,3,4, Irene Medina-Martínez5, Miguel Quesada-Caballero3,6
1Department of Nursing, Faculty of Health Sciences, University of Granada, 18016 Granada, Spain.
Objectives:
To analyze the effects of the combination of Extra Virgin Olive Oil (EVOO) supplementation and a health-related lifestyle intervention on disease activity and cardiovascular disease risk factors in Systemic Lupus Erythematosus (SLE).
Methods:
A total of 38 women with SLE were randomly assigned to EVOO (n = 9) and EVOO combined with multicomponent health promotion and physical exercise program (EVOO + HRLI) (n = 15) or control (CG) (n = 14) groups for 24 weeks. Baseline and post-intervention assessments were performed, collecting data on disease activity, accrual damage, blood biochemical parameters, arterial stiffness parameters, Framingham risk score, anthropometric and body composition measurements, and cardiovascular risk factors.
Results:
No changes in disease activity were observed in any group after the intervention. For cardiovascular risk, significant differences were observed in the intervention groups for systolic and mean blood pressure, with greater reductions in the EVOO + HRLI (p = 0.036 vs. p < 0.001; p = 0.017 vs. p < 0.001, respectively). The EVOO group showed significant reductions in BFM and BFP (p = 0.042, p = 0.022, respectively). The EVOO+ HRLI group also showed significant reductions in triglycerides (p < 0.001), Aix brachial (p = 0.037), central systolic blood pressure (p < 0.001), central pulse pressure (p = 0.05), body mass index (p = 0.006), body fat mass and skeletal muscle mass (p = 0.039) after the intervention.
Conclusions:
Our findings suggest that a multidisciplinary program integrating nutritional interventions, health education, and the promotion of regular physical activity in SLE patients has the potential to significantly improve cardiovascular risk factors and body composition parameters. Thus, integrating this approach into clinical practice alongside usual pharmacological treatments would be beneficial for SLE patients.
Clinical Trial Registration:
NCT05261529.
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