NCT05261529: EFINUTRILES

Effects of an Intervention With EVOO and Physical Activity in Patients With Systemic Lupus Erythematosus

Status unknown NA Last updated 20 December 2022

What this trial tests

NA trial testing Extra Virgin Olive Oil (EVOO) in Lupus Erythematosus, Systemic in 90 participants. Status unknown.

Timeline

3 November 2021

Primary endpoint
30 December 2022

30 June 2023

Quick facts

Lead sponsor	Universidad de Granada
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	90
Start date	3 November 2021
Primary completion	30 December 2022
Estimated completion	30 June 2023
Sites	1 location across Spain

Drugs / interventions tested

• Extra Virgin Olive Oil (EVOO)
• Physical Exercise Program

Conditions studied

• Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →

Sponsor

Universidad de Granada — full company profile →

Who can join

Adults 18 to 70, female only, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In addition to the different pharmacological therapies available for the treatment of Systemic Lupus Erythematosus (SLE) as well as for its numerous associated complications (cutaneous, articular, hematological, neuropsychiatric, renal...), it has recently been proposed that 'health-related lifestyles' could have a determining role in balancing numerous organic processes at all levels. In line with this, the benefits of following a healthy dietary pattern such as the Mediterranean Diet and, specifically, the intake of Extra Virgin Olive Oil (EVOO) as well as the realization of regular physical exercise (PE) have been examined in numerous chronic non-communicable diseases such as obesity or cancer. However, in patients with autoimmune diseases, such as SLE, the possible effects of this synergy has not been investigated to date. Having demonstrated both the protective effect of a healthy dietary pattern and that of regular PE on the progression and risks associated with SLE in cross-sectional studies, non-intervention research has been developed that combines both strategies simultaneously, with nutritional supplementation or PE occurring independently. It is hypothesized that supplementation with EVOO in these patients together with PE will produce superior benefits compared to EVOO supplementation alone, showing changes in the phenotype of SLE and other parameters such as levels of chronicity/gravity, biomarkers (oxidative stress, immunological, inflammation), cardiovascular status and body composition.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. EFINUTRILES Study: Integrative Extra Virgin Olive Oil and Multimodal Lifestyle Interventions for Cardiovascular Health and SLE Management.
   Gil-Gutiérrez R, Medina-Martínez I, Quesada-Caballero M, de la Hera-Fernández FJ, et al · · 2025 · cited 1× · PMID 40292522 · DOI 10.3390/nu17061076
2. Profiling miRNA in Systemic Lupus Erythematosus Patients Adhering to a Mediterranean Diet: An Interventional Pilot Study
   Gil-Gutiérrez R, Medina-Martínez I, Membrive-Jiménez M, Caballero-Mateos A, et al · · 2026