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Clinical Trial Summary

The purpose of this study was to verify the effect of chronic 12-week high-dose Colostrum Bovinum (COL) and placebo (PLA) supplementation on immunological, hematological and biochemical markers, as well as physical capacity and discipline-specific exercise performance in endurance athletes, in a randomized, double-blind, placebo-controlled crossover trial.


Clinical Trial Description

Colostrum Bovinum (COL) is a substance produced naturally by mammary glands of mammals for 24-72 h after calving. The significant impact of COL supply on the development of the immune system of the calves has led to the beginning of the use of COL supplementation in humans to improve their immune functions. Intense physical activity suppresses immunity up to several hours after training, which is known as the "open window". Due to large volumes of intense efforts that athletes of endurance sports disciplines undergo (especially swimmers and triathletes), they are at high risk for immunological disorders, especially upper respiratory tract infections (URTI), such as the common cold. There are limited studies applying to the supplementation of COL in athletes in order to positively affect immune system. Currently, there is only one systematic review and meta-analysis of 5 randomized controlled trials showing that oral supplementation of COL can reduce the incidence rate of URTI days and episodes in athletes. In terms of immunological biomarkers, there are conflicting studies. In one of them, a 33% increase in salivary secretory (SIgA) was observed after 2-week of 20g COL supplementation. In the other study, the use of a 12-week period of supplementation of a chocolate drink containing 12 g COL in a group of runners led to a 79% increase in resting SIgA. On the contrary, some of the studies found no significant difference in SIgA between COL-supplemented and placebo groups. However, latter studies found beneficial effects of COL intake on the stimulation of neutrophil oxidative burst, blunting the prolonged exercise-induced decrease in in vivo immune responsiveness to a novel antigen and the reduction in exercise-induced muscle damage and markers of inflammation. Based on these results, it can be concluded that COL supplementation may have a beneficial effect on the immune system of athletes. However, it is required to conduct well-controlled standardized studies, which can be characterized by the sufficient dose and period of the effective supplementation, to identify markers of immune system adequate for evaluation of the response in case of such stimulation. Therefore, the study aimed to examine the effect of chronic 12-week high-dose COL and placebo (PLA) supplementation on immunological, hematological and biochemical markers, as well as physical capacity and discipline-specific exercise performance in endurance athletes, in a randomized, double-blind, placebo-controlled crossover trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06390670
Study type Interventional
Source Poznan University of Physical Education
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 30, 2021
Completion date March 31, 2024

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