Clinical trial NCT06166030: IMMUNERECOV CONTRIBUTES TO IMPROVEMENT OF RESPIRATORY AND IMMUNOLOGICAL RESPONSE IN POST-COVID-19 PATIENTS.
Official title: EFFECTS OF WHEY PROTEIN SUPPLEMENTATION ON CARDIOPULMONARY, MUSCLE AND IMMUNOHEMATOLOGICAL RESPONSES OF POST-COVID-19 PATIENTS.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Long Covid19
Dietary Supplements
Respiratory Tract Infections
Inflammation
Keywords: COVID-19
dietary supplementation
inflammation
lung function
muscle strength
SARS-CoV-2
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Effects of ImmuneRecov on Lung Function and Immune Response
timeFrame: Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response
Secondary outcomes:
measure: Effects of ImmuneRecov on Peripheral and Respiratory Muscle Strength
timeFrame: Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength
Other outcomes:
Locations:
city: Sao Jose dos Campos
country: Brazil
facility: Laboratory of Pulmonary and Exercise Immunology
state: Sao Paulo
city: São José dos Campos
country: Brazil
facility: Laboratory of Pulmonary and Exercise Immunology - Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Rodolfo de Paula Vieira, BSc., MSc., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.