A controlled, randomized clinical trial is proposed to demonstrate the effectiveness ofthe experimental product in controlling hepato-pulmonary inflammation and neurovascularencephalic inflammation, which may constitute the etiopathogenic basis of persistentCOVID. In addition, an individualized training program will be implemented for eachparticipant in order to improve chronic symptoms and, consequently, their quality oflife.
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.
Dietary Supplement: Experimental Product
Supplement consisting of orange extract, apigenin, luteolin, yerba mate extract,
grapefruit extract, and olive leaf extract.
Dietary Supplement: Control placebo
Product with identical characteristics to the experimental product.
Other: Physical exercise
During the study, subjects will have to develop a training program. A multicomponent
program will be carried out during the 4 months of product consumption. The sessions will
last 60 minutes and will be held 2-3 times per week.
Other: No Physical Exercise
During the study, subjects will only consume the product assigned to them in the
randomization.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 32.
- Pregnant or lactating women.
UCAM HiTech, Sport & Health Innovation Hub
Murcia, Spain
Investigator: Francisco Javier López Román
Contact: 968278157
jlroman@ucam.edu
Francisco Javier López Román
968278157 - 157
jlroman@ucam.edu
Not Provided