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

NCT ID: NCT05261529

Last Updated: 2022-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2023-06-30

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.

Detailed Description

SLE is one of the more representative autoimmune diseases that courses with several manifestations which are cutaneous-mucosal, joint, hematologic, neuropsychiatric and/or renal. In addition to the different pharmacological therapies available for its treatment, the adequate management of 'health-related lifestyles' becomes a relevant strategy by balancing, among others, the dysbiosis of the microbiota, the production of metabolites and the alteration of the immune response, with positive repercussions on all organic processes. Mediterranean Diet (MD), and the intake of EVOO in specific, which is its most representative food, has been shown to be a proven dietary pattern of protection against chronic non-communicable diseases. In line with this, Physical Exercise (PE) is another strategy on the rise. Regular exercise at moderate intensity has great impact on the immune system, the central nervous system, as a regulator of hormones and blood glucose levels, and on the psychosocial and cognitive spheres, ultimately leading to the appearance of numerous beneficial modifications in the face of external pathogenic aggressions and inflammatory processes.

Therefore, the synergy between DM and PE could enhance the known beneficial effects of both types of approaches in patients with SLE, as the scientific literature has shown in other chronic diseases such as obesity or cancer, among others. However, there are currently few studies that include PE interventions, and there is also some contradiction in the results. In addition, there is no study that synergizes both approaches in a coincident manner over time. The present study, whose main objective is to analyze the influence of the addition to a supplementation with EVOO of a multimodal combined physical exercise intervention in patients with SLE, is developed under the hypothesis that: The combination of dietary supplementation with EVOO together with the follow-up of a multimodal PE program will result in superior benefits in SLE patients with respect to a group of patients solely supplemented with EVOO, showing changes in SLE phenotype and parameters such as levels of chronicity/severity of the disease, levels of biochemical, immunological, inflammatory and oxidative stress markers, markers of cardiovascular risk and early atherosclerosis and endothelial function, cardiorespiratory status and body composition.

For this purpose, a 24-week clinical trial will be developed with three groups of patients with SLE (30 patients/group): a control group (no intervention), another that will add to the usual intake pattern of 40ml of EVOO daily during 24 weeks, and a third group that will add to this additional intake of EVOO the follow-up of a specific PE program in the middle of the intervention (12 weeks).

Data collection in all groups will be perform before the intervention, at an intermediate stage and coinciding with the beginning of the PE program (12 weeks), and at the end of the study (24 weeks).

The study will be carried out in three phases:

STAGE 1: Reinforcement of adherence to DM. In order to guarantee during the intervention the maintenance of the levels of adherence to DM established as inclusion criteria, previously and in both groups the basic principles of DM will be recalled by a nutritionist, through group sessions of 1 hour of duration.

STAGE 2: Intervention. EVOO supplementation, or EVOO supplementation + PE under the conditions previously described. The intervention, which will be extended over 24 weeks, will consist of the daily consumption of 40 ml of EVOO in a single daily intake, added to the usual intake pattern of the participants.

• CG. The participants' usual lifestyle (dietary pattern and physical activity) will not be modified.
• Intervention Group 1. Patients will take the EVOO supplementation as describe below, without changing their physical activity routines.
• Intervention Group 2. In addition to taking EVOO supplementation, patients will start following a Multimodal Physical Exercise (MFE) program during the remaining 12 weeks of intervention, guided by personnel with experience in the area: 3 days per week, groupal sessions (≤10 participants/group) on non-consecutive days, both online and face-to-face sessions. Continuous (4-6weeks) and intervallic (week 5-7 to 24) cardiovascular exercise will be worked at moderate-intense intensity, controlled by HR in reserve, with a duration of 15-45 minutes. In addition, sympathetic modulation exercises (stretching, breathing, meditation) will be used as methods to promote recovery, with a duration of 10-30 minutes. In this group, supplementation will take place after exertion.

STAGE 3: Post-intervention data collection (week 25).

Conditions

Lupus Erythematosus, Systemic

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oil Group

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.

Group Type: EXPERIMENTAL

Extra Virgin Olive Oil (EVOO)

Intervention Type: DIETARY_SUPPLEMENT

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

Oil + Exercise Group

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.

Group Type: EXPERIMENTAL

Extra Virgin Olive Oil (EVOO)

Intervention Type: DIETARY_SUPPLEMENT

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

Physical Exercise Program

Intervention Type: 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.

Interventions

Extra Virgin Olive Oil (EVOO)

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

Intervention Type: DIETARY_SUPPLEMENT

Physical Exercise Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Consejería de Economía, Innovación y Ciencia. Proyectos de I+D+I en el marco operativo Feder Andalucía 2014-2020

UNKNOWN

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

María Correa-Rodríguez

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María Correa Rodríguez, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Universidad de Granada

Granada, Granada, Spain, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

María Corea Rodríguez, Professor

Role: CONTACT

Phone: 958243494

Email: macoro@ugr.es

Blanca M Rueda Medina, Professor

Role: CONTACT

Phone: 958243494

Email: blarume@ugr.es

Facility Contacts

María Correa Rodríguez, Professor

Role: primary

Blanca M Rueda Medina, Professor

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 32594173 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40292522 (View on PubMed)

Other Identifiers

2099-N-21

Identifier Type: -

Identifier Source: org_study_id