The Effect of Colostrum Bovinum Supplementation in Endurance Athletes

Poznan University of Physical Education

Status and phase: Completed; Phase 3; Phase 2

Conditions: Supplementation; Aerobic Capacity; Biochemical Markers; Sports Nutrition; Exercise Performance

Treatments: Other: Placebo treatment; Dietary Supplement: Colostrum Bovinum supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06390670

ZDS2022_0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• written consent to participate,
• a good health condition without chronic health disorders,
• a valid and up-to-date medical certificate confirming the athlete's ability to practice sports,
• at least 5 years of triathlon/swimming training experience,
• regular participation in triathlon/swimming competitions on at least national level.

Exclusion criteria

• allergy to cow's milk proteins,
• lactose intolerance,
• any autoimmune diseases,
• reporting symptoms of infection or taking any medication (longer than 3 days) for 4 weeks before the enrollment to the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

COL supplementation

Experimental group

Description:

The experimental procedure for each participant in this group includes a 12-week period of COL supplementation. The entire study protocol included familiarization and 4 main visits to the laboratory (T1-T4; pre/post supplementation with COL and PLA). After the familiarization, enrolled volunteers were randomly assigned (stratified randomization) to the treatment order by an impartial biostatistician. A 4-week washout period was introduced between treatments. The main study protocol included body mass and composition evaluation, 3 saliva and blood samplings (resting \[REST\]; 3 min \[POST-EX\] and 60 min after completion of the second test exercise \[REC\]) and 2 exercise protocols during each of T1-T4 study visit (interspaced with 50 min of passive rest and 10 min of warm-up before the second exercise test). All testings were performed in the morning hours at the same time for the participant, to avoid physiological diurnal fluctuations in measured saliva and blood outcomes.

Treatment:

Dietary Supplement: Colostrum Bovinum supplementation

PLA treatment

Placebo Comparator group

Description:

The experimental procedure for each participant in this group includes a 12-week period of PLA supplementation. The entire study protocol included familiarization and 4 main visits to the laboratory (T1-T4; pre/post supplementation with COL and PLA). After the familiarization, enrolled volunteers were randomly assigned (stratified randomization) to the treatment order by an impartial biostatistician. A 4-week washout period was introduced between treatments. The main study protocol included body mass and composition evaluation, 3 saliva and blood samplings (resting \[REST\]; 3 min \[POST-EX\] and 60 min after completion of the second test exercise \[REC\]) and 2 exercise protocols during each of T1-T4 study visit (interspaced with 50 min of passive rest and 10 min of warm-up before the second exercise test). All testings were performed in the morning hours at the same time for the participant, to avoid physiological diurnal fluctuations in measured saliva and blood outcomes.

Treatment:

Other: Placebo treatment