Effects of a Nutricional Intervention With EVOO Oil and Physical Activity in Patients With Systemic Lupus Erythematosus: Effect on Clinical Course, Epigenetic and Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- SLEDAI Systemic Lupus Erythematosus Disease Activity Index
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible if they have been diagnosed with SLE for at least one year and have been seen at the Outpatient Clinic of the Systemic Autoimmune Diseases Unit of the Hospital Universitario Clínico San Cecilio of Granada (Spain), meet the revised American College of Rheumatology (ACR), SLICC or ACR/EULAR criteria of 2019 and maintain a stable SLEDAI-2K, without treatment modifications, in the previous 3 months.
- •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).
排除标准
- •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)
研究组 & 干预措施
Control Group
Control Group with 30 patients diagnosed with SLE following their normal lifestyle in terms of dietary intake and physical exercise.
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.
干预措施: Extra Virgin Olive Oil (EVOO) (Dietary Supplement)
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.
干预措施: Extra Virgin Olive Oil (EVOO) (Dietary Supplement)
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.
干预措施: Physical Exercise Program (Behavioral)
结局指标
主要结局
SLEDAI Systemic Lupus Erythematosus Disease Activity Index
时间窗: Participants will be followed over 24 weeks.
SLE-specific index that assess disease activity through a combination of data from clinical records, physical examination, organ-specific functional tests and serological studies.
次要结局
- Microbiome characteristics analysis(Participants will be followed over 24 weeks.)
- Super Oxide Dismutase concentration(Participants will be followed over 24 weeks.)
- 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.)
- Creatinine level(Participants will be followed over 24 weeks.)
- Lipid profile analysis(Participants will be followed over 24 weeks.)
- Creatine Kinase concentration(Participants will be followed over 24 weeks.)
- Hemoglobin concentration(Participants will be followed over 24 weeks.)
- Number of lymphocytes(Participants will be followed over 24 weeks.)
- Number of platelets(Participants will be followed over 24 weeks.)
- Number of leukocytes(Participants will be followed over 24 weeks.)
- Inflammation(Participants will be followed over 24 weeks.)
- Anti phospholipid antibodies concentration(Participants will be followed over 24 weeks.)
- Double-stranded anti-DNA antibodies concentration(Participants will be followed over 24 weeks.)
- Complement fraction C3 concentration(Participants will be followed over 24 weeks.)
- Complement fraction C4 concentration(Participants will be followed over 24 weeks.)
- Cardiorespiratory Fitness(Participants will be followed over 24 weeks.)
- Functional capacity(Participants will be followed over 24 weeks.)
- Hight(Participants will be followed over 24 weeks.)
- Weight(Participants will be followed over 24 weeks.)
- Skeletal Muscle Mass(Participants will be followed over 24 weeks.)
- Body Fat Mass(Participants will be followed over 24 weeks.)
- Body Mass Index(Participants will be followed over 24 weeks.)
- Body Fat Index(Participants will be followed over 24 weeks.)
- Waist-to-hip ratio in centimeters(Participants will be followed over 24 weeks.)
- Obesity degree(Participants will be followed over 24 weeks.)
- Body Cell Mass(Participants will be followed over 24 weeks.)
- Bone Mineral Content(Participants will be followed over 24 weeks.)
- Basal Metabolic Rate(Participants will be followed over 24 weeks.)
- Visceral Fat Area(Participants will be followed over 24 weeks.)
- Bone density(Participants will be followed over 24 weeks.)
- Human Vascular Cell Adhesion Molecule-1 concentration(Participants will be followed over 24 weeks.)
- Intercellular Adhesion Molecule-1concentration(Participants will be followed over 24 weeks.)
- E-Selectin concentration(Participants will be followed over 24 weeks.)
- Glutathione concentration(Participants will be followed over 24 weeks.)
- Total Antioxidant Capacity concentration(Participants will be followed over 24 weeks.)
- Thiobarbituric Acid Reactive Substances concentration(Participants will be followed over 24 weeks.)
- Malondialdehyde concentration(Participants will be followed over 24 weeks.)
- Advanced Oxidation Protein Products concentration(Participants will be followed over 24 weeks.)
- Total proteins concentration(Participants will be followed over 24 weeks.)
- Endothelial Function(Participants will be followed over 24 weeks.)
- miRNA expression profile quantification(Participants will be followed over 24 weeks.)
研究者
María Correa-Rodríguez
Associate Professor
Universidad de Granada