The Effect of Colostrum Bovinum Supplementation in Endurance Athletes

NCT06390670 | Completed Phase 2

• 1 other identifier: ZDS2022_0002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sports dietetics; Immunomodulation; Immunodepression; Physical capacity; Performance

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  12 weeks during COL supplementation and PLA treatment.

Secondary Outcomes (19)

• Changes in white blood cells count after COL supplementation and PLA treatment.

  Before and after 12 weeks of COL suplementation and PLA treatment.

• Changes in white blood cells differential after COL supplementation and PLA treatment.

  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.

  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.

  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.

  Before and after 12 weeks of COL suplementation and PLA treatment.

Study Arms (2)

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.

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.

Other: Placebo treatment

Interventions

Colostrum Bovinum supplementation 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.

COL supplementation

Placebo treatment 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.

PLA treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• Nutricia Foundation: collaborator
• Poznan University of Life Sciences: collaborator

Study Sites (1)

Department of Sports Dietetics, Poznan University of Physical Education

Poznan, Wielkopolska, 61-871, Poland

Location

Related Publications (1)

• 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.

  PMID: 40254930 DERIVED

Study Officials

• Krzysztof Durkalec-Michalski, Prof., PhD

  Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr hab., PhD

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 30, 2024
• Study Start: March 30, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

PL (1)