The Effect of Colostrum Bovinum Supplementation in Endurance Athletes

NCT ID: NCT06390670

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2024-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

COL supplementation

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.

Group Type: EXPERIMENTAL

Colostrum Bovinum supplementation

Intervention Type: DIETARY_SUPPLEMENT

In the experimental procedure each athlete was supplemented with a chronic dose of 25 g/day of COL. Supplement was particularly prepared for the study from a first post-delivery milking and had a high content of IgG (60%; certified Colostrum Bovinum; Agrapak, Poland). The COL was provided in the powder form and were taken twice a day (12.5 g in the morning and 12.5 g in the afternoon). Participants were instructed to dissolved each portion of the COL supplement in 250 mL of plain water.

PLA treatment

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.

Group Type: PLACEBO_COMPARATOR

Placebo treatment

Intervention Type: OTHER

In the control procedure each athlete was supplemented with a chronic dose of 25 g/day of placebo (PLA). PLA was particularly prepared for the study, and was an isoenergetic/isomacronutrient product (high quality protein) prepared for the trial (Agrapak, Poland). The PLA was provided in the powder form and were taken twice a day (12.5 g in the morning and 12.5 g in the afternoon). Participants were instructed to dissolved each portion of the PLA preparation in 250 mL of plain water.

Interventions

Colostrum Bovinum supplementation

In the experimental procedure each athlete was supplemented with a chronic dose of 25 g/day of COL. Supplement was particularly prepared for the study from a first post-delivery milking and had a high content of IgG (60%; certified Colostrum Bovinum; Agrapak, Poland). The COL was provided in the powder form and were taken twice a day (12.5 g in the morning and 12.5 g in the afternoon). Participants were instructed to dissolved each portion of the COL supplement in 250 mL of plain water.

Intervention Type: DIETARY_SUPPLEMENT

Placebo treatment

In the control procedure each athlete was supplemented with a chronic dose of 25 g/day of placebo (PLA). PLA was particularly prepared for the study, and was an isoenergetic/isomacronutrient product (high quality protein) prepared for the trial (Agrapak, Poland). The PLA was provided in the powder form and were taken twice a day (12.5 g in the morning and 12.5 g in the afternoon). Participants were instructed to dissolved each portion of the PLA preparation in 250 mL of plain water.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Foundation

OTHER

Sponsor Role: collaborator

Poznan University of Life Sciences

OTHER

Sponsor Role: collaborator

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Krzysztof Durkalec-Michalski

Prof Dr hab., PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krzysztof Durkalec-Michalski, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Physical Education

Locations

Department of Sports Dietetics, Poznan University of Physical Education

Poznan, Wielkopolska, Poland

Countries

Poland

References

Durkalec-Michalski K, Glowka N, Podgorski T, Wochna K, Wozniewicz M, Nowaczyk PM. Twelve-Week Colostrum Bovinum Supplementation Supports Aerobic Capacity but has No Effect on Body Composition in Endurance-Trained Males: A Randomized Placebo-Controlled Crossover Study. Eur J Sport Sci. 2025 May;25(5):e12288. doi: 10.1002/ejsc.12288.

Reference Type: DERIVED

PMID: 40254930 (View on PubMed)

Other Identifiers

ZDS2022_0002

Identifier Type: -

Identifier Source: org_study_id