Clinical trial NCT06390670: The Effect of Colostrum Bovinum Supplementation in Endurance Athletes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sports Nutrition
Biochemical Markers
Exercise Performance
Aerobic Capacity
Supplementation
Keywords: Sports dietetics
Immunomodulation
Immunodepression
Physical capacity
Performance
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
name: Poznan University of Life Sciences
First posted: 2024-04-30
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in saliva secretory IgA (SIgA) concentration after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in upper respiratory tract infections rate during COL supplementation and PLA treatment.
timeFrame: 12 weeks during COL supplementation and PLA treatment.
Secondary outcomes:
measure: Changes in white blood cells count after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in white blood cells differential after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: 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.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in blood Interferon-gamma cytokine (IFN-γ) after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in blood immunoglobulins A (IgA), M (IgM), G (IgG) after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in blood immunoglobulins D (IgD) and E (IgE) after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in salivary bacterial load after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in blood natural killer cells after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in aerobic capacity and incremental rowing test (IRT) performance measured by maximum workload at exhaustion after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in aerobic capacity measured by maximal oxygen uptake after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in the discipline-specific exercise performance after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in lactate concentration (mmol/L) before and after exercise tests after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in heart rate during exercise protocols.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: 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.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in nutritional status indices (concentration of total protein and albumin, glucose) (g/dL) after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Changes in Insulin-like Growth Factor 1 (IGF-1) (ng/mL) after COL supplementation and PLA treatment.
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Analysis of body composition (fat-free mass, fat mass).
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Analysis of body composition (% fat-free mass, % fat mass).
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
measure: Analysis of body composition (total body water).
timeFrame: Before and after 12 weeks of COL suplementation and PLA treatment.
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Sports Dietetics, Poznan University of Physical Education
state: Wielkopolska
Study officials:
affiliation: Poznan University of Physical Education
name: Krzysztof Durkalec-Michalski, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
References: