IMMUNERECOV CONTRIBUTES TO IMPROVEMENT OF RESPIRATORY AND IMMUNOLOGICAL RESPONSE IN POST-COVID-19 PATIENTS.

Inflammation Clinical Trial

— IRPC  

Official title:

EFFECTS OF WHEY PROTEIN SUPPLEMENTATION ON CARDIOPULMONARY, MUSCLE AND IMMUNOHEMATOLOGICAL RESPONSES OF POST-COVID-19 PATIENTS.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166030
• Other study ID #: 4.637.661
• Status: Recruiting
• Phase: Phase 3
• Start date: December 10, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: December 2023
• Source: Federal University of São Paulo
• Contact: Rodolfo de Paula Vieira, BSc., MSc., PhD.
• Phone: 55 12 991410615
• Email: rodrelena[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients.

Description:

Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients. Design: This is a non-controlled open label prospective clinical study. Methods: Fifty-eight post-COVID-19 patients were recruited and twenty-four accepted to take the nutritional blend, while twenty-four did not accept but required to participate in the evaluations and 10 refused to participate. So, the patients were evaluated before the 14th day after hospital discharge and after 30 days of use of the nutritional blend or control (no supplementation).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 15, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: The inclusion criteria encompassed post-COVID-19 patients with a confirmed COVID-19 diagnosis through a positive RT-PCR test, who also required hospitalization, meeting the criteria for moderate severity classification as defined by the World Health Organization (WHO). In summary, according to the WHO, moderate illness is characterized by individuals who exhibit signs of lower respiratory disease during clinical assessment or imaging and maintain an oxygen saturation level (SpO2) of =94% while breathing room air at sea level.

Exclusion Criteria: Exclusion criteria included individuals discharged from the hospital for more than 14 days and those who initiated physical activity or began taking any dietary supplements or vitamins.

Related Conditions & MeSH terms

• COVID-19
• Dietary Supplements
• Inflammation
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Nutritional blend (ImmuneRecov).
Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response.

Locations

Country	Name	City	State
Brazil	Laboratory of Pulmonary and Exercise Immunology	Sao Jose dos Campos	Sao Paulo
Brazil	Laboratory of Pulmonary and Exercise Immunology - Federal University of Sao Paulo	São José dos Campos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Franco JVA, Garegnani LI, Oltra GV, Metzendorf MI, Trivisonno LF, Sgarbossa N, Ducks D, Heldt K, Mumm R, Barnes B, Scheidt-Nave C. Long-Term Health Symptoms and Sequelae Following SARS-CoV-2 Infection: An Evidence Map. Int J Environ Res Public Health. 2022 Aug 11;19(16):9915. doi: 10.3390/ijerph19169915. — View Citation

Prokopidis K, Mazidi M, Sankaranarayanan R, Tajik B, McArdle A, Isanejad M. Effects of whey and soy protein supplementation on inflammatory cytokines in older adults: a systematic review and meta-analysis. Br J Nutr. 2023 Mar 14;129(5):759-770. doi: 10.1017/S0007114522001787. Epub 2022 Jun 16. — View Citation

Wang S, Qi X. The Putative Role of Astaxanthin in Neuroinflammation Modulation: Mechanisms and Therapeutic Potential. Front Pharmacol. 2022 Jun 24;13:916653. doi: 10.3389/fphar.2022.916653. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of ImmuneRecov on Lung Function and Immune Response	Effects of ImmuneRecov on Lung Function and Immune Response	Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response
Secondary	Effects of ImmuneRecov on Peripheral and Respiratory Muscle Strength	Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength	Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength