Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390670
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-21
Brief Title:
The Effect of Colostrum Bovinum Supplementation in Endurance Athletes
Sponsor:
Poznan University of Physical Education
Organization:
Poznan University of Physical Education
Study Overview
Official Title:
The Effect of Colostrum Bovinum Supplementation on Upper Respiratory Tract Infections Rate and Selected Immunological Biomarkers in Trained Athletes a Randomized Crossover Placebo-controlled Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None