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

NCT05261529 | Unknown

• 1 other identifier: 2099-N-21
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lupus Erythematosus, Systemic

Keywords

Mediterranean Diet; Olive Oil; Physical Exercise; Autoimmune Diseases; Systemic Lupus Erythematosus; Microbiome; Epigenetcis

Outcome Measures

Primary Outcomes (1)

• SLEDAI Systemic Lupus Erythematosus Disease Activity Index

  SLE-specific index that assess disease activity through a combination of data from clinical records, physical examination, organ-specific functional tests and serological studies.

  Participants will be followed over 24 weeks.

Secondary Outcomes (45)

• Cumulative manifestations

  Participants will be followed over 24 weeks.

• SLICC/ACR (Systemic Lupus International Collaborating clinics/American College of Rheumatology) Damage Index for Systemic Lupus Erythematosus.

  Participants will be followed over 24 weeks.

• Pharmacological prescription

  Participants will be followed over 24 weeks.

• Glucose level

  Participants will be followed over 24 weeks.

• Urea level

  Participants will be followed over 24 weeks.

Study Arms (3)

Control Group

NO INTERVENTION

Control Group with 30 patients diagnosed with SLE following their normal lifestyle in terms of dietary intake and physical exercise.

Oil Group

EXPERIMENTAL

Group with 30 patients diagnosed with SLE that add to their normal dietary intake a supplementation with 40ml of EVOO daily during 24 weeks, without changing their lifestyle in terms of physical exercise.

Dietary Supplement: Extra Virgin Olive Oil (EVOO)

Oil + Exercise Group

EXPERIMENTAL

Group with 30 patients diagnosed with SLE that besides adding to their normal dietary intake a supplementation with 40ml of EVOO daily during 24 weeks, will follow a physical exercise multimodal program the 12 last weeks.

Dietary Supplement: Extra Virgin Olive Oil (EVOO); Behavioral: Physical Exercise Program

Interventions

Extra Virgin Olive Oil (EVOO) DIETARY_SUPPLEMENT

Daily intake of 40ml EVOO added to the normal intake of EVOO of the participants.

Oil + Exercise Group; Oil Group

Physical Exercise Program BEHAVIORAL

Besides the EVOO supplementation in the same conditions as the 'Intervention 1 Group', participants will add the follow-up of a Multimodal Physical Exercise (MFE) program during the remaining 12 weeks of intervention, 3 days per week, online and face-to-face group sessions on non-consecutive days. Continuous and intervalic cardiovascular exercise at moderate-intense intensity, controlled by the HR in reserve, with a duration of 15-45 minutes, also including sympathetic modulation exercises (stretching, breathing and meditation) and methods to promote recovery, with a duration of 10-30 minutes.

Oil + Exercise Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medium (8 to 11 points) to high (12 to 14 points) level of adherence to DM as measured by the 14-point DM adherence scale of the PREDIMED study.
• Sedentary, inactive or non-performing subjects of structured PE (+5h sitting or doing less than 300min of weekly physical activity or \<60min structured exercise per week).

You may not qualify if:

• Terminal stages of the disease
• Serum creatinine levels ≥1.5mg / dl
• Type 1 Diabetes Mellitus
• Infection, trauma or surgery six months prior to intervention
• SLICC\> 5
• Pregnant, with intention, or breastfeeding
• Diagnosis of other autoimmune / inflammatory diseases
• Participation in other PE guided programs
• Contraindication for PE: psychiatric or cognitive disorders, acute or chronic conditions (advanced lung disease, high requirements, stenosis\> 70%)
• BMI of morbid obesity (≥40)

Sponsors & Collaborators

• Universidad de Granada: lead
• Consejería de Economía, Innovación y Ciencia. Proyectos de I+D+I en el marco operativo Feder Andalucía 2014-2020: collaborator

Study Sites (1)

Universidad de Granada

Granada, Granada, Spain, 18016, Spain

RECRUITING

Related Publications (2)

• Pocovi-Gerardino G, Correa-Rodriguez M, Callejas-Rubio JL, Rios-Fernandez R, Martin-Amada M, Cruz-Caparros MG, Rueda-Medina B, Ortego-Centeno N. Beneficial effect of Mediterranean diet on disease activity and cardiovascular risk in systemic lupus erythematosus patients: a cross-sectional study. Rheumatology (Oxford). 2021 Jan 5;60(1):160-169. doi: 10.1093/rheumatology/keaa210.

  PMID: 32594173 BACKGROUND

• Gil-Gutierrez R, Medina-Martinez I, Quesada-Caballero M, de la Hera-Fernandez FJ, Zamora-Pasadas M, Cantarero-Villanueva I, Albendin-Garcia L, Parola V, Rueda-Medina B, Correa-Rodriguez M. EFINUTRILES Study: Integrative Extra Virgin Olive Oil and Multimodal Lifestyle Interventions for Cardiovascular Health and SLE Management. Nutrients. 2025 Mar 19;17(6):1076. doi: 10.3390/nu17061076.

  PMID: 40292522 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Motor Activity; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Behavior

Study Officials

• María Correa Rodríguez, Professor

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Corea Rodríguez, Professor

CONTACT

958243494; macoro@ugr.es

Blanca M Rueda Medina, Professor

CONTACT

958243494; blarume@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants randomly assigned in a 1:1:1 ratio to each of the three groups established through a centralized method with computer support (OxMaR software).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Three-arm prospective randomized controlled 24-week clinical trial of patients diagnosed with SLE.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 2, 2022
• Study Start: November 3, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)