Long-term bovine colostrum supplementation in football players
| ISRCTN | ISRCTN13834604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13834604 |
- Submission date
- 18/10/2023
- Registration date
- 07/11/2023
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Physical exercise, especially of high intensity, is a significant burden to the athlete's body. It should be emphasized that achieving high results in competitive sports requires the use of significant, sometimes extreme, exercise loads during training, which may result in homeostasis disorders, adversely affecting the fitness of athletes. The supplementation of bovine colostrum (BC) has a documented immunomodulatory effect on the players' diet and may be one of the elements of a safe and gentle intervention that restores homeostasis e.g., the balance of the immune system. There is also increasing evidence that BC may be a valuable supplement for athletes to aid exercise performance and recovery
Thus the study aims to investigate the effects of 6 months of bovine colostrum supplementation on indicators of immune system functioning, selected parameters related to iron management, pro-anti inflammatory and anabolic/catabolic balance in young football players.
Who can participate?
The research participants were men, football players who met the following criteria: the inclusion criteria included: 1) competitive football training for at least 3 years; 2) male; 3) not taking any medications throughout the study and 4) providing voluntary consent for participation in the study. The exclusion criteria included: 1) any health problems.
What does the study involve?
The study is a randomized clinical trial designed to compare the effects of 6 months of bovine colostrum supplementation on the functioning of the immune system of soccer players. A standardized stress test will be performed at the beginning of the trial and after 3 and 6 months of supplementation. Blood samples were taken before and after the stress test and after 3 hours of rest. Blood will be taken from each athlete from the ulnar vein in the amount of 2x4ml (clot test tube and EDTAK2 tube): on an empty stomach, immediately after exercise and 3 hours after exercise The level of: IGF-1, testosterone, cortisol, IL-10, IL-6, TNF-α, IgG, lactoferrin, iron, hepcidin, TIBC, UIBC will be determined. A significant increase in IgG levels was seen, accompanied by a decrease in inflammatory markers (TNF-α).
What are the possible benefits and risks of participating?
The main benefits of taking the supplement are shortening the time and improving post-exercise regeneration processes in athletes, improving the functioning of the immune system, strengthening immunity, and regulating hormonal balance, which in intensively training athletes are disturbed by physical exercise. Previously conducted studies indicate that the dose administered in our studies is safe for humans and does not cause side effects.
Where is the study run from?
Department of Human Physiology, Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz (Poland)
Department of Biological Sciences, Faculty of Physical Culture in Gorzow Wielkopolski, Poznan University of Physical Education (Poland)
When is the study starting and how long is it expected to run for?
February 2017 to November 2018
Who is funding the study?
Regional Operational Program—Lubuskie 2020 (Poland)
Who is the main contact?
Dr Joanna Ostapiuk-Karolczuk, j.ostapiuk@awf-gorzow.edu.pl
Contact information
Public, Scientific, Principal Investigator
ul. Estkowskiego 13
Gorzow Wielkopolski
66-400
Poland
 ORCID ID |
0000-0003-4214-1488 |
|---|---|
| Phone | +48 95 729246 |
| j.ostapiuk@awf-gorzow.edu.pl |
Study information
| Study design | Interventional randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Fitness/sport facility, Laboratory |
| Study type | Prevention |
| Participant information sheet | 44440 PIS.pdf |
| Scientific title | The influence of the supply of polyphenol compounds on the parameters of the pro-oxidant and pro-oxidant balance and inflammation indicators in physically active people |
| Study acronym | LTBCSFP |
| Study objectives | H1. Bovine colostrum supplementation will improve iron metabolism in training soccer players in response to intense physical exercise. H2. Bovine colostrum supplementation will improve the functioning of the immune system in training soccer players in response to intense physical exercise. H3. Bovine colostrum supplementation will have a positive effect on the pro-anti-inflammatory balance in training football players in response to intense physical exercise. H4. Bovine colostrum supplementation will influence the hormonal balance in training football players in response to intense physical exercise. |
| Ethics approval(s) |
Approved 13/06/2017, Bioethics Committee of the Nico-laus Copernicus University in Toruń at the Collegium Medicum Ludwik Rydygier (M.Skłodowskiej-Curie 9, Bydgoszcz, 85-094, Poland; +48 52 585 25 63; komisja.bioetyczna@cm.umk.pl), ref: KB 382/2017 |
| Health condition(s) or problem(s) studied | Prevention of iron, inflammatory, and hormonal disturbances in trained athletes after intense exercise. |
| Intervention | Before the supplementation, the players were randomly divided into two groups. The supplemented group (n=19) received four gastro-resistant capsules of BC (produced by AGRAPAK, Poland) every morning and evening. One gel capsule contained 0.4 g of colostrum. The composition of the supplement per day dose of 3.2 g of colostrum (four capsules in the morning and four in the evening): total protein - 2.620 g, lactose - 0.16 g, fat - 0.05 g, active protein substances (lactoferrin - 30 mg, PRP (platelet-rich plasma) - 0.16 g, IgG - 1050 mg, IGF - 16 µg, LZM - 21.2 mg, and αLA - 30 mg). The PRP content was estimated by measuring the content and ratio of amino acids (Pro and Val) based on the conducted research and analysis of bibliographic data. The placebo group (n=9) received powdered milk in the same dose, form, and date as the competitors. The composition of the placebo was calculated for a single dose of 3.2 g: lactose 1.6 g, protein 1.08 g, fat 0.04 g, and ash 0.25. The supplementation period lasted for 24 weeks in total. The supplement study was performed using two types of preparations: a supplement and a placebo. Identical-looking capsules were prepared for both preparations. The contents (supplement and placebo) were very similar to each other (white powder) with virtually identical taste and smell consistency. Both preparations were packed in identical packages, marked with numbers that corresponded to the numbers assigned to the athletes during randomization. Only the study leader knew the details of the coding and he supervised the distribution of preparations for athletes. Neither the participants nor the people conducting the experiment had access to key information that could influence its course. This information is available only to the main coordinator of the experiment - the study leader, who does not participate in the experiment himself, but analyzes its results after other people have completed collecting all the data. |
| Intervention type | Supplement |
| Primary outcome measure | Immune system activity and inflammatory response were measured using IgG level, IL-6, TNF-α, IL-10, at baseline, immediately after exercise, and 3h at each performed exercise test. |
| Secondary outcome measures | 1. Speed of exercise measured during the Beep Test at baseline (before supplementation) and after 3 and 6 months of supplementation 2 Number of sections run in the Beep Test t baseline (before supplementation) and after 3 and 6 months of supplementation |
| Overall study start date | 01/02/2017 |
| Completion date | 15/11/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Days |
| Upper age limit | 30 Days |
| Sex | Male |
| Target number of participants | Participants were assessed and randomly allocated to one of two groups: supplemented (n=19) and placebo (n=9). |
| Total final enrolment | 28 |
| Key inclusion criteria | 1. Competitive football training for at least 3 years 2. Male 3. Not taking any medications throughout the study 4. Provide voluntary consent for participation in the study |
| Key exclusion criteria | Any health problems. |
| Date of first enrolment | 07/05/2018 |
| Date of final enrolment | 10/05/2018 |
Locations
Countries of recruitment
- Poland
Study participating centres
Bydgoszcz
85-092
Poland
Bydgoszcz
58-064
Poland
Gorzow Wielkopolski
66-400
Poland
Sponsor information
Government
ul. Chrobrego 1
Zielona Góra
65-043
Poland
| Phone | +48 68 4565 480 |
|---|---|
| pife.zielonagora@lubuskie.pl | |
| Website | https://rpo.lubuskie.pl/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 06/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be published in Nutrients (IF 5,9; open access) |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from (please provide contact name and email address) for 12 months from the publication date of the article. Mirosława Cieślicka e-mail: m.cieslicka@cm.umk.pl |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/10/2023 | No | Yes | ||
| Results article | 14/11/2023 | 21/01/2025 | Yes | No |
Additional files
Editorial Notes
21/01/2025: Publication reference added.
19/10/2023: Trial's existence confirmed by Bioethics Committee of the Nico-laus Copernicus University in Toruń at the Collegium Medicum Ludwik Rydygier.
