Clinical Trial to Analyze the Effectiveness of a Natural Compound on Chronic Immune-mediated Inflammatory Status in Subjects Who Have Had SARS-CoV-2 Infection.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Universidad Católica San Antonio de Murcia
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Immunoinflammatory profile
概览
简要总结
A controlled, randomized clinical trial is proposed to demonstrate the effectiveness of the experimental product in controlling hepato-pulmonary inflammation and neurovascular encephalic inflammation, which may constitute the etiopathogenic basis of persistent COVID. In addition, an individualized training program will be implemented for each participant in order to improve chronic symptoms and, consequently, their quality of life.
详细描述
Randomized, placebo-controlled, double-blind clinical trial with four parallel arms based on the product consumed (placebo or experimental product) and the performance of physical exercise (exercise or no exercise), designed to analyze the effectiveness of the product under investigation in reducing chronic immune-mediated inflammatory status in subjects who have had SARS-CoV-2 infection and present persistent symptoms 3 months after the onset of the infectious process.
The efficacy of the experimental product, consumed over a period of 4 months, will be determined in terms of reducing chronic inflammation and improving the quality of life of people suffering from this condition.
Clinical manifestations and chronic symptoms, quality of life, response to the individualized physical exercise program, and product safety will be taken into account.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind study in relation to product consumption. Blinding cannot be performed in relation to physical exercise.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes.
- •Subjects over 18 and under 70 years of age who have had a SARS-CoV-2 infection diagnosed by PDIA.
- •Subjects with a history of SARS-CoV-2 infection who, three months after the onset of COVID-19, continue to experience symptoms lasting at least two months that cannot be explained by another cause. These symptoms may be newly developed after initial recovery from an acute COVID-19 episode or persist from the initial illness.
- •No history of sequelae from a severe acute illness.
排除标准
- •Subjects with an underlying disease that explains the clinical manifestations.
- •Presence of chronic inflammatory diseases.
- •Subjects with acute infections.
- •Evidence of active thromboembolic disorder, defined as those receiving parenteral anticoagulant or thrombolytic treatment.
- •Excessive alcohol consumption.
- •Hypersensitivity or intolerance to any of the components of the study products.
- •Use of any nutraceutical or dietary supplement.
- •Severe or terminal illnesses.
- •Subjects with a body mass index (BMI) over
- •Pregnant or lactating women.
研究组 & 干预措施
Placebo
Subjects in this group will consume a placebo product (maltodextrin) with the same organoleptic characteristics as the investigational product.
干预措施: Control placebo (Dietary Supplement)
Placebo
Subjects in this group will consume a placebo product (maltodextrin) with the same organoleptic characteristics as the investigational product.
干预措施: No Physical Exercise (Other)
Natural extract
Subjects in this group will consume the investigational product (experimental product composed of a combination of six natural extracts: grapefruit extract, apigenin, orange extract, luteolin, yerba mate extract, and olive leaf extract).
干预措施: Experimental Product (Dietary Supplement)
Natural extract
Subjects in this group will consume the investigational product (experimental product composed of a combination of six natural extracts: grapefruit extract, apigenin, orange extract, luteolin, yerba mate extract, and olive leaf extract).
干预措施: No Physical Exercise (Other)
Physical exercise and consumption of experimental product
During the study, subjects must consume the experimental product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.
干预措施: Experimental Product (Dietary Supplement)
Physical exercise and consumption of experimental product
During the study, subjects must consume the experimental product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.
干预措施: Physical exercise (Other)
Physical exercise and consumption of placebo product
During the study, subjects must consume the placebo product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.
干预措施: Control placebo (Dietary Supplement)
Physical exercise and consumption of placebo product
During the study, subjects must consume the placebo product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.
干预措施: Physical exercise (Other)
结局指标
主要结局
Immunoinflammatory profile
时间窗: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 120 days of product intake.
Antibody assay for molecular biomarkers of the brain-liver-lung axis, blood-brain barrier, immunometabolic pathways, and immune-inflammatory and immuno-angiogenic cardiac remodeling.
次要结局
- Clinical signs(It will be recorded twice, before starting the consumption of the product and before the end of consumption (120 days))
- Short Form 12 Health Survey(It will be measured twice, once at baseline and at the end of the study after 120 days of consumption.)
- Sleep quality(Progress will be measured after 120 days of consumption.)
- Sleep efficiency(Progress will be measured after 120 days of consumption.)
- Fatigue(Progress will be measured after 120 days of consumption.)
- Dyspnea(Progress will be measured after 120 days of consumption.)
- Depression(Progress will be measured after 120 days of consumption.)
- Anxiety(Progress will be measured after 120 days of consumption.)
- Hospital Anxiety and Depression(Progress will be measured after 120 days of consumption.)
- Stress level(Progress will be measured after 120 days of consumption.)
- Cardiorespiratory fitness.(Progress will be measured after 120 days of consumption.)
- The Rate of Force Development(Progress will be measured after 120 days of consumption.)
- Adverse events(After 16 weeks of consumption.)
- Maximum Voluntary Isometric Contraction(Progress will be measured after 120 days of consumption.)
- Body composition(The test will be measured at baseline and after 16 weeks of consumption.)
- Liver safety variables(Hematological samples were taken before (day 0) and after consumption of the product (day 120) both in the control group and in the experimental group.)
研究者
Francisco Javier López Román
Bachelor of Medicine
Universidad Católica San Antonio de Murcia