Sports NutritionPhase 2/3NCT06390670
The Effect of Colostrum Bovinum Supplementation in Endurance Athletes
A Phase 2/3 study testing Colostrum Bovinum supplementation in people with Sports Nutrition and Biochemical Markers, run by Poznan University of Physical Education at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutrition, Biochemical Markers, Exercise Performance
- What is being tested?
- Colostrum Bovinum supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- 30 Mar 2021to 31 Mar 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site
Department of Sports Dietetics, Poznan University of Physical Education
Poznan, Wielkopolska, 61-871
About this study
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
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.
Read the 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
- Being tested
- Colostrum Bovinum supplementation, Placebo treatment
- Keywords
- Sports dietetics, Immunomodulation, Immunodepression, Physical capacity, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colostrum Bovinum supplementationDietary 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.
Placebo treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COL supplementation | Experimental | 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. Receives: Dietary Supplement: Colostrum Bovinum supplementation |
| PLA treatment | Placebo comparator | 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. Receives: Other: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in saliva secretory IgA (SIgA) concentration after COL supplementation and PLA treatment.
Assessment of the saliva SIgA concentration (μg/mL) at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in upper respiratory tract infections rate during COL supplementation and PLA treatment.
Assessment of the upper respiratory tract infections (URTI) rate by measuring rate ratio of URTI days, rate ratio of episodes of URTI and duration of URTI episodes during assigned interventions (during COL and PLA treatment).
Measured: 12 weeks during COL supplementation and PLA treatment.
Secondary outcomes (19)
Changes in white blood cells count after COL supplementation and PLA treatment.
Assessment of the white blood cells (neutrophils, monocytes, lymphocytes, granulocytes, neutrophils:lymphocytes ratio) (count/L) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in white blood cells differential after COL supplementation and PLA treatment.
Assessment of the white blood cells (neutrophils, monocytes, lymphocytes, granulocytes) (%) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood Tumour Necrosis Factor alpha (TNF- α), Interleukin-6 (IL-6), and Interleukin-10 (IL-10) cytokines after COL supplementation and PLA treatment.
Assessment of the TNF- α, IL-6, and IL-10 cytokines concentration (pg/mL) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood Interferon-gamma cytokine (IFN-γ) after COL supplementation and PLA treatment.
Assessment of the IFN-γ concentration (ng/L) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood immunoglobulins A (IgA), M (IgM), G (IgG) after COL supplementation and PLA treatment.
Assessment of the IgA, IgM, IgG immunoglobulins concentration (g/L) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood immunoglobulins D (IgD) and E (IgE) after COL supplementation and PLA treatment.
Assessment of the IgD, IgE immunoglobulins concentration (IU/mL) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in salivary bacterial load after COL supplementation and PLA treatment.
Assessment of the salivary bacterial load (count/mL) at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood natural killer cells after COL supplementation and PLA treatment.
Assessment of the natural killer cells (count) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in aerobic capacity and incremental rowing test (IRT) performance measured by maximum workload at exhaustion after COL supplementation and PLA treatment.
Assessment of the aerobic capacity and IRT performance (measured by maximum workload at exhaustion in Watts) was carried out by an incremental rowing test to exhaustion at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in aerobic capacity measured by maximal oxygen uptake after COL supplementation and PLA treatment.
Assessment of the aerobic capacity (maximal oxygen uptake in mL/min/kg) was carried out by an incremental rowing test to exhaustion at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in the discipline-specific exercise performance after COL supplementation and PLA treatment.
Assessment of the exercise performance (time trial performance in min) was carried out during a swimming-specific performance test consisting of eight 100-meter-long sections to swim through, of which the sections I-III were performed at level of 75% maximal effort [ME, determined during the familiarization visit], IV-V at 85% ME, VI at 90% ME, VII at 95% ME and VIII at 100% ME), with 1 to 2.5 min of recovery between sections. The test was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in lactate concentration (mmol/L) before and after exercise tests after COL supplementation and PLA treatment.
Assessment of the lactate concentration (mmol/L) was performed at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA) from fingertip capillary blood: a) before and 3-min after the IRT to exhaustion; b) during recovery break between sections of the discipline-specific exercise performance test and 3-min after the last section at four main visits to the laboratory; and c) 1 h after the cessation of the second exercise protocol (the discipline-specific exercise performance test).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in heart rate during exercise protocols.
Assessment of the heart rate (bpm) during both exercise protocols was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood C-C motif chemokines Ligand 2 (CCL2), 3 (CCL3), 4 (CCL4), and C-X-C motif chemokine ligand 9 (CXCL9) after COL supplementation and PLA treatment.
Assessment of the CCL2, CCL3, CCL4, CXCL9 chemokines concentration (pg/mL) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in nutritional status indices (concentration of total protein and albumin, glucose) (g/dL) after COL supplementation and PLA treatment.
Assessment of the nutritional status indices (concentration of total protein, albumin, glucose) concentration (g/dL) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in Insulin-like Growth Factor 1 (IGF-1) (ng/mL) after COL supplementation and PLA treatment.
Assessment of the IGF-1 concentration (ng/mL) in blood at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Analysis of body composition (fat-free mass, fat mass).
Assessment of body composition (fat-free mass, fat mass) (kg) was carried out before the execution of exercise protocols on each research visit.
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Analysis of body composition (% fat-free mass, % fat mass).
Assessment of body composition (% of fat-free mass, and % of fat mass) was carried out before the execution of exercise protocols on each research visit.
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Analysis of body composition (total body water).
Assessment of body composition (total body water) (%) was carried out before the execution of exercise protocols on each research visit.
Measured: Before and after 12 weeks of COL suplementation and PLA treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Mar 2021
- Primary completion1 Mar 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sports NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Foundation, Poznan University of Life Sciences
- Responsible party
- Principal investigator, Krzysztof Durkalec-Michalski, Poznan University of Physical Education
- Investigators
- Krzysztof Durkalec-Michalski, Prof., PhD, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390670
- Sponsor's protocol ID
- ZDS2022_0002
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40254930Durkalec-Michalski K, Glowka N, Podgorski T, Wozniewicz M, Nowaczyk PM. The effect of 12-week high-dose Colostrum Bovinum supplementation on immunological, hematological and biochemical markers in endurance athletes: a randomized crossover placebo-controlled study. Front Immunol. 2024 Oct 21;15:1425785. doi: 10.3389/fimmu.2024.1425785. eCollection 2024.
PubMed 39497827
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06390670
- Acronym / sponsor ID
- ZDS2022_0002
- Conditions
- Sports Nutrition, Biochemical Markers, Exercise Performance, Aerobic Capacity, Supplementation
- Keywords
- Sports dietetics, Immunomodulation, Immunodepression, Physical capacity, Performance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Nutricia Foundation, Poznan University of Life Sciences
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COL supplementation | Experimental | Dietary Supplement: Colostrum Bovinum supplementationThe 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. |
| PLA treatment | Placebo comparator | Other: Placebo treatmentThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colostrum Bovinum supplementationIn 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. | Dietary supplement | COL supplementation |
| Placebo treatmentIn 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. | Other | PLA treatment |
Primary outcome
Changes in saliva secretory IgA (SIgA) concentration after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Assessment of the saliva SIgA concentration (μg/mL) at three time-points (resting [REST]; 3 min [POST-EX] and 60 min after completion of the second test exercise [REC]) was carried out at four main visits to the laboratory (T1-T4; before/after supplementation with COL and PLA).
Changes in upper respiratory tract infections rate during COL supplementation and PLA treatment.
Time frame: 12 weeks during COL supplementation and PLA treatment.
Assessment of the upper respiratory tract infections (URTI) rate by measuring rate ratio of URTI days, rate ratio of episodes of URTI and duration of URTI episodes during assigned interventions (during COL and PLA treatment).
19 secondary outcomes
Changes in white blood cells count after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in white blood cells differential after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood Tumour Necrosis Factor alpha (TNF- α), Interleukin-6 (IL-6), and Interleukin-10 (IL-10) cytokines after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood Interferon-gamma cytokine (IFN-γ) after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood immunoglobulins A (IgA), M (IgM), G (IgG) after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood immunoglobulins D (IgD) and E (IgE) after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in salivary bacterial load after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood natural killer cells after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in aerobic capacity and incremental rowing test (IRT) performance measured by maximum workload at exhaustion after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in aerobic capacity measured by maximal oxygen uptake after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in the discipline-specific exercise performance after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in lactate concentration (mmol/L) before and after exercise tests after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in heart rate during exercise protocols.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in blood C-C motif chemokines Ligand 2 (CCL2), 3 (CCL3), 4 (CCL4), and C-X-C motif chemokine ligand 9 (CXCL9) after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in nutritional status indices (concentration of total protein and albumin, glucose) (g/dL) after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Changes in Insulin-like Growth Factor 1 (IGF-1) (ng/mL) after COL supplementation and PLA treatment.
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Analysis of body composition (fat-free mass, fat mass).
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Analysis of body composition (% fat-free mass, % fat mass).
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Analysis of body composition (total body water).
Time frame: Before and after 12 weeks of COL suplementation and PLA treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 40254930Durkalec-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.
- Derived from this study: PubMed 39497827Durkalec-Michalski K, Glowka N, Podgorski T, Wozniewicz M, Nowaczyk PM. The effect of 12-week high-dose Colostrum Bovinum supplementation on immunological, hematological and biochemical markers in endurance athletes: a randomized crossover placebo-controlled study. Front Immunol. 2024 Oct 21;15:1425785. doi: 10.3389/fimmu.2024.1425785. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Durkalec-Michalski, Prof., PhD principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colostrum Bovinum supplementation in people with Sports Nutrition and Biochemical Markers, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in saliva secretory IgA (SIgA) concentration after COL supplementation and PLA treatment. (time frame: Before and after 12 weeks of COL suplementation and PLA treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06390670, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.