Endothelial Function, Post COVID Syndrome, Supplemental Nutrition Assistance Program Education
Conditions
Keywords
Post-COVID-19 syndrome, Endothelial function, Body composition, L-citrulline, Physical functionality
Brief summary
This study aims to evaluate the impact of a non-pharmacological treatment (nutritional therapy and pulmonary rehabilitation) on endothelial function, body composition, and physical functionality in recovered COVID-19 patients. The primary research question is: What is the effect of a non-pharmacological treatment (nutritional therapy and pulmonary rehabilitation) on endothelial function, body composition, and physical capacity in recovered COVID-19 patients, compared to those receiving conventional medical management? A nutritional treatment combined with L-citrulline supplementation (intervention group) will be compared against conventional treatment alone (control group). Both groups will undergo pulmonary rehabilitation for a 3-month follow-up. Subjects assigned to the intervention group will be required to: * Take 4 g of L-citrulline daily for 3 months. * Attend an interim session at 1.5 months for review of the nutritional treatment and supplementation. * Keep a record of each supplement intake.
Detailed description
Coronavirus Disease 2019 (COVID-19), caused by SARS-CoV-2, represents a global public health crisis that has resulted in severe complications and death in more than 500,000 individuals worldwide. The risk factors for severe COVID-19 include age over 70 years, hypertension, diabetes mellitus, smoking, coronary artery disease, and obesity, which have been associated with endothelial dysfunction (ED). The coexistence of chronic non-communicable diseases significantly exacerbates the inflammatory response, increasing the risk of adverse events and poor prognosis. Similarly, a high probability of cardiovascular diseases in subjects is at elevated risk of severe COVID-19, due to the overexpression of angiotensin-converting enzyme 2. In addition, in our country, the leading causes of death are related to metabolic diseases: 19% of men and women between the ages of 30 and 69 die from cardiovascular diseases, with diabetes ranking as the second leading cause of death. Furthermore, 76.6% of the population is overweight or obese, and 25.5% has hypertension, factors that render our population particularly susceptible to moderate to severe COVID-19. Moreover, both pharmacological and non-pharmacological treatments have primarily focused on the acute phase of infection. However, it is essential to implement treatment protocols, including pulmonary rehabilitation and nutritional therapy with citrulline supplementation or immunonutrients with anti-inflammatory properties, to prevent Post-Intensive Care Syndrome, reduce systemic inflammation, and improve endothelial function. These interventions may collectively enhance protein synthesis, attenuate muscle mass loss, and promote patient autonomy, functional recovery, and overall quality of life. Post-COVID-19 syndrome Post-COVID-19 syndrome has been defined as the persistence of symptoms and/or delayed long-term remission of complications arising from SARS-CoV-2 infection, occurring beyond 4 weeks after initial symptom onset. Nutritional supplementation L-citrulline L-Citrulline is a non-essential, water-soluble alpha-amino acid and a potent endogenous precursor of L-arginine, which increases the bioavailability of NO. In endothelial cells, NO is synthesized from L-arginine by endothelial nitric oxide synthase, yielding NO and L-citrulline. Endothelial dysfunction ED is a systemic condition in which the endothelium loses its physiological properties, including vascular permeability, vascular tone regulation, and neutrophil recruitment, thereby promoting a prothrombotic, proinflammatory, and pro-oxidant state. General objective: To evaluate the impact of a non-pharmacological intervention (nutritional therapy and pulmonary rehabilitation) on endothelial function, body composition, and physical functionality in recovered COVID-19 patients. Specific objectives: To evaluate the impact of a non-pharmacological intervention (nutritional therapy and pulmonary rehabilitation) on endothelial function in recovered COVID-19 patients. To evaluate the impact of a non-pharmacological intervention (nutritional therapy and pulmonary rehabilitation) on body composition in recovered COVID-19 patients. To evaluate the impact of a non-pharmacological intervention (nutritional therapy and pulmonary rehabilitation) on physical functionality in recovered COVID-19 patients. To evaluate the impact of a non-pharmacological intervention (nutritional therapy and pulmonary rehabilitation) on quality of life in recovered COVID-19 patients. Secondary objectives: To describe the prevalence of sarcopenia in recovered COVID-19 patients. To describe cardiovascular alterations in recovered COVID-19 patients. To describe alterations in body composition in recovered COVID-19 patients. To describe metabolic alterations in recovered COVID-19 patients. To evaluate the effect of a non-pharmacological intervention (nutritional therapy and pulmonary rehabilitation) on muscle strength in recovered COVID-19 patients. To evaluate the effect of a non-pharmacological intervention (nutritional therapy and pulmonary rehabilitation) on pulmonary function in recovered COVID-19 patients.
Interventions
DIETARY_SUPPLEMENTL-citrulline supplementation
Subjects allocated to the intervention group receive 4 grams of L-citrulline supplementation daily, combined with nutritional therapy, over a 3-month period.
Sponsors
Instituto Nacional de Enfermedades Respiratorias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open-label, randomized controlled clinical trial was conducted.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Recovered COVID-19 patients with a negative PCR test for SARS-CoV-2. * Subjects between 40 and 80 years. * Subjects who give written informed consent to participate in the study.
Exclusion criteria
* Subjects diagnosed with Human Immunodeficiency Virus (HIV). * Subjects diagnosed with cancer. * Subjects with a glomerular filtration rate (GFR) \<30 ml/min/1.73 m². * Subjects currently enrolled in another interventional study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial disfunction markers | 3 months | E-Selectin, ng/ml was Serum nitric oxide concentration was assessed indirectly through the enzymatic conversion of nitrate to nitrite (pg/ml). sE-Selectin (ng/ml) and Endothelin-1 (ng/ml) levels were measured using a human enzyme-linked immunosorbent assay (ELISA) kit (R\&D Systems, Inc., Minneapolis, MN, USA). ICAM-1 (ng/mg of protein )and VCAM-1 (ng/mg of protein) was assessed using a method is the sandwich enzyme-linked immunosorbent assay (ELISA). |
| Body composition | 3 months | Body composition was measured using whole-body electrical bioimpedance with RJL Systems Quantum single-frequency. Weight was expressed in kilograms, fat-mass in percentage, phase angle in grades, and the appendicular skeletal muscle mass index in kg/m2. |
| Physical functionality | 3 months | Handgrip strength was measured using a mechanical Smedley Hand Dynamometer, this outcome measure was expressed in kilograms. Exercise tolerance was evaluated using a six-minute walk test, the distance covered was expressed in meters. Pulmonary rehabilitation: static and dynamic balance, gait, fall risk, cognitive function, peripheral strength assessed by manual muscle testing, quality of life, anxiety and depression screening, and perceived disability. The results were presented in scores obtained for each test. |
Countries
Mexico
Outcome results
None listed