Innate ImmunityNCT06123910
Bovine Colostrum Supplementation in Athletes
A study testing Colostrum bovine in people with Innate Immunity, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 1 site in Mexico.
Trial summary
32 recreational athletes who will attend to the Grand Marathon in the nort west of Mexico, event that will be held on December 2, 2018 or 21k Trail to be held in April 2019 will be invited to the study. Participants will be informed about the study procedures through a consent informed. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Innate Immunity
- What is being tested?
- Colostrum bovine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 10 Oct 2018to 5 Apr 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 3 years of training experience
- training for a half marathon competition
- No smokers
- Taking any kind of food supplements
- No alimentary allergies
Who cannot join
- Injuries
- not follow experimental indications
- cardiovascular disease
- treatment intolerances
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Investigación en Alimentación y Desarrollo
Hermosillo, Sonora, 83304
About this study
Official title: Effect of Bovine Colostrum Supplementation on Neutrophil Function in Recreational Athletes
32 recreational athletes who will attend to the Grand Marathon in the nort west of Mexico, event that will be held on December 2, 2018 or 21k Trail to be held in April 2019 will be invited to the study. Participants will be informed about the study procedures through a consent informed. Participants will be randomly divided into two groups, 16 in the intervention group and 16 in the comparison group. The participants will be recreational athletes between 18 and 60 years old. They must have athletic experience of at least 3 years. The participants considered will be those who perform vigorous physical activity per week according to the criteria of the short version IPAQ instrument. Smoking subjects with food intolerances and allergies, cardiovascular history will be excluded. Patients who have had a respiratory infection symptom in the last two weeks will not be able to participate in the study. Participants who are consuming some type of food supplement will be excluded.
Two 18 ml of blood samples will be taken from the vein of the forearm by venipuncture of each participant, using K2EDTA tubes after and before supplementation period. Blood samples were taken before a corporal, aerobic and nutritional evaluations.
CB supplementation will begin 4 weeks prior to competition events. One group will consume 20 g of bovine colostrum daily in solution with water. The second group will consume a placebo product with a nutritional composition similar to the group with the treatment of bovine colostrum. Both groups should take the supplement before breakfast with empty stomach.
Read the detailed description
It is widely accepted that exercise provide important health benefits. However, vigorous or extenuate exercise can affect the correct function of the immune system. Athletes who perform extreme physical routines to improve their athletic performance can develop opportunistic infections. After 3 to 72 h of physical activity there is a phase called "open window for infection", which predispose to upper track respiratory infection (UTRI). URTI is the main cause of medical consultation in athletes with vigorous exercise practices.
Neutrophils are one of the most abundant leucocytes in blood; their phagocytic activity is essential to control bacterial infections. Recently, the interest in knowing the participation of these cells in the sport field is growing. Neutrophilia refers to a high concentration of neutrophils in blood, and this is a common condition after exercise. The controversial part is that vigorous exercise could limit some important functions, such as oxidative burst, degranulation and phagocytosis until 6 h after exercise. However, there are contradictory results in this topic.
To alleviate those immunological alterations in athletes, a nutritional intervention should be included. Bovine colostrum has been evaluated as a supplement due to its potential immunomodulatory properties. It improves immunological parameters in individuals who achieve prolonged exercise sessions, allowing URTI reduction. Bovine colostrum is a yellow aqueous compound secreted by cow mammary glands the first 72 h after partum. Bovine colostrum contains anti-microbial peptides, enzymes, immunoglobulins, cytokines, microRNA and growth factors, which are able to modulate the immune system, at local (intestinal) and systemic level. Due to these characteristics, bovine colostrum has been used to improve the immune response under different physiological conditions.
A study showed that bovine colostrum supplementation induces a CD89 expression pre-exercise, after 5 weeks supplementation with 10 g of bovine colostrum. This result is important, since CD89 is a membrane receptor in neutrophils that recognize antibody/antigen complexes to prime phagocytosis and degranulation. In other study, 3 weeks of bovine colostrum supplementation improved neutrophil degranulation 1 h post-exercise in athletes, after 2 h of physical exercise. Authors evaluated neutrophil oxidative burst post-exercise after bovine colostrum supplementation, but no effects were observed. However, these authors found better oxidative burst after 4 weeks bovine colostrum supplementation. At this time, the effect of bovine colostrum in phagocytosis activity is unknown.
Concerning the effects of bovine colostrum supplementation in the URTI incidence, the results are contradictory. Although, others found no benefit in the incidence of URTI after a bovine colostrum supplementation, other studies showed promising results. A retrospective analysis conducted in 2003 showed a reduction of athletes with URTI in the bovine colostrum supplementation group. Likewise, another study reported less episodes and duration of infections in physically active subjects. Other studies described a tendency to decrease the incidence of URTI in swimmers and cyclists.
Study Design
A total of 28 athletes attending the "Hermosillo Grand Marathon" (December 2, 2018) and/or the "Hermosillo Half Marathon" (March 2019) will be part of this study. In this randomized clinical trial, study subjects will be randomly divided in two groups, 14 in the intervention group (bovine colostrum supplementation) and 14 in the comparison group (placebo supplementation). The participants will be recreational athletes between 18 and 60 years old. They must have athletic experience of at least 3 years and have to perform a vigorous physical activity per week according to the criteria of the short version IPAQ instrument. Smoking subjects, with food intolerances, allergies or cardiovascular history will not be included. Athletes with respiratory infection symptoms two weeks before beginning the supplementation won't be part of this protocol. Participants who are consuming some other type of food supplement will not be included. This protocol is currently under evaluation of the Ethics Committee of our institution. Participants will be informed about the study procedures and will sign an informed consent.
Bovine colostrum supplementation will begin 4 weeks prior to the competition event. The intervention group will consume 20 g of bovine colostrum, divided into two doses of 10 g/day. The first dose will be before breakfast and the second before lunch. The comparison group will consume a placebo product.
Two blood samples (24 ml of each one) will be taken from the vein of the forearm of each participant, using tubes with EDTA. The first sample will be taken before the competitive event after 10 min of a sitting rest. The second sample will be obtained immediately at the end of the test with 3 minutes of sitting rest.
- Conditions
- Innate Immunity
- Being tested
- Colostrum bovine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colostrum bovineDietary supplement
Also called sovereign laboratories colostrum ld powder
Colostrum bovine supplements, 25 kcal per portion, containing 0.25 g fats, 2.0 g CHO and 3 g protein. Lactose reduced.
PlaceboOther
Also called Milk powder
Dairy comercial product. 25 kcal per portion, 1.3 g fats, 1.95 CHO and 1.3 protein. Lactose based.
| Study group | Role | What they receive |
|---|---|---|
| Colostrum bovine | Experimental | Subjets taking a colostrum supplement Receives: Dietary Supplement: Colostrum bovine |
| Placebo | Placebo comparator | Subjets taking a commercial dairy product Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil phagocytic capacity
Percentage of phagocytic neutrophils
Measured: Before and after 4 weeks of supplementation
Monocytes phagocytic capacity
Percentage of phagocytic monocytes
Measured: Before and after 4 weeks of supplementation
neutrophils producing reactive oxygen species
percentage of positive cells to fluorescence intensity by flow cytometry
Measured: before and after 4 weeks of supplementation
neutrophils reactive oxygen species production intensity
Mean intensity fluorescent by cells measured by flow cytometry
Measured: Before and after 4 weeks of supplementation
Monocytes producing reactive oxygen species
percentage of positive cells to fluorescence intensity by flow cytometry
Measured: before and after 4 weeks of supplementation
Monocytes reactive oxygen species production intensity
Mean intensity fluorescent by cells measured by flow cytometry
Measured: Before and after 4 weeks of supplementation
VO2Max
Indicates participants aerobic condition (ml/kg/min)
Measured: Before and after 4 weeks of supplementation
Days presenting upper respiratory tract symptoms
Total of days that participants refers any kind of upper respiratory symptoms
Measured: During supplementation 4 weeks of supplementation
Secondary outcomes (6)
Weight
Weight in kilograms
Measured: before and after 4 weeks of supplementation
Height
Height in meters
Measured: before and after 4 weeks of supplementation
Body fat
Body fat percentage
Measured: before and after 4 weeks of supplementation
Fat free mass
fat free mass percentage
Measured: before and after 4 weeks of supplementation
Energy consumption
Measure of regular calories consumption in kcal by 24 h records method
Measured: before, after 2 and 4 weeks of supplementation
Macronutrient consumption
Measure of regular consumption of carbohydrates in grams, Protein in grams, fats in grams by 24 h records method
Measured: before, after 2 weeks and 4 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start10 Oct 2018
- Primary completion13 Nov 2018
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Innate ImmunityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesús Hernández, PhD, Principal investigator, Centro de Investigación en Alimentación y Desarrollo A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123910
- Sponsor's protocol ID
- JHDEZ/CE/010-1/2018
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hackney AC, Koltun KJ. The immune system and overtraining in athletes: clinical implications. Acta Clin Croat. 2012 Dec;51(4):633-41.
PubMed 23540172Li TL, Gleeson M. The effect of single and repeated bouts of prolonged cycling on leukocyte redistribution, neutrophil degranulation, IL-6, and plasma stress hormone responses. Int J Sport Nutr Exerc Metab. 2004 Oct;14(5):501-16. doi: 10.1123/ijsnem.14.5.501.
PubMed 15673097Peake J, Suzuki K. Neutrophil activation, antioxidant supplements and exercise-induced oxidative stress. Exerc Immunol Rev. 2004;10:129-41.
PubMed 15633591Tritto ACC, Amano MT, De Cillo ME, Oliveira VA, Mendes SH, Yoshioka C, Roschel H, Camara NOS, Gualano B, Artioli GG. Effect of rapid weight loss and glutamine supplementation on immunosuppression of combat athletes: a double-blind, placebo-controlled study. J Exerc Rehabil. 2018 Feb 26;14(1):83-92. doi: 10.12965/jer.1835154.577. eCollection 2018 Feb.
PubMed 29511657Bermon S, Castell LM, Calder PC, Bishop NC, Blomstrand E, Mooren FC, Kruger K, Kavazis AN, Quindry JC, Senchina DS, Nieman DC, Gleeson M, Pyne DB, Kitic CM, Close GL, Larson-Meyer DE, Marcos A, Meydani SN, Wu D, Walsh NP, Nagatomi R. Consensus Statement Immunonutrition and Exercise. Exerc Immunol Rev. 2017;23:8-50.
PubMed 28224969Jones AW, Thatcher R, March DS, Davison G. Influence of 4 weeks of bovine colostrum supplementation on neutrophil and mucosal immune responses to prolonged cycling. Scand J Med Sci Sports. 2015 Dec;25(6):788-96. doi: 10.1111/sms.12433. Epub 2015 Feb 28.
PubMed 25727914Shing CM, Peake J, Suzuki K, Okutsu M, Pereira R, Stevenson L, Jenkins DG, Coombes JS. Effects of bovine colostrum supplementation on immune variables in highly trained cyclists. J Appl Physiol (1985). 2007 Mar;102(3):1113-22. doi: 10.1152/japplphysiol.00553.2006. Epub 2006 Nov 9.
PubMed 17095643Rathe M, Muller K, Sangild PT, Husby S. Clinical applications of bovine colostrum therapy: a systematic review. Nutr Rev. 2014 Apr;72(4):237-54. doi: 10.1111/nure.12089. Epub 2014 Feb 26.
PubMed 24571383Crooks CV, Wall CR, Cross ML, Rutherfurd-Markwick KJ. The effect of bovine colostrum supplementation on salivary IgA in distance runners. Int J Sport Nutr Exerc Metab. 2006 Feb;16(1):47-64. doi: 10.1123/ijsnem.16.1.47.
PubMed 16676703Soligard T, Steffen K, Palmer D, Alonso JM, Bahr R, Lopes AD, Dvorak J, Grant ME, Meeuwisse W, Mountjoy M, Pena Costa LO, Salmina N, Budgett R, Engebretsen L. Sports injury and illness incidence in the Rio de Janeiro 2016 Olympic Summer Games: A prospective study of 11274 athletes from 207 countries. Br J Sports Med. 2017 Sep;51(17):1265-1271. doi: 10.1136/bjsports-2017-097956. Epub 2017 Jul 29.
PubMed 28756389Palmer-Green D, Elliott N. Sports injury and illness epidemiology: Great Britain Olympic Team (TeamGB) surveillance during the Sochi 2014 Winter Olympic Games. Br J Sports Med. 2015 Jan;49(1):25-9. doi: 10.1136/bjsports-2014-094206. Epub 2014 Nov 25.
PubMed 25425714McCarthy DA, Macdonald I, Grant M, Marbut M, Watling M, Nicholson S, Deeks JJ, Wade AJ, Perry JD. Studies on the immediate and delayed leucocytosis elicited by brief (30-min) strenuous exercise. Eur J Appl Physiol Occup Physiol. 1992;64(6):513-7. doi: 10.1007/BF00843760.
PubMed 1618188Davison G, Diment BC. Bovine colostrum supplementation attenuates the decrease of salivary lysozyme and enhances the recovery of neutrophil function after prolonged exercise. Br J Nutr. 2010 May;103(10):1425-32. doi: 10.1017/S0007114509993503. Epub 2009 Dec 24.
PubMed 20030905Pyne DB, Baker MS, Fricker PA, McDonald WA, Telford RD, Weidemann MJ. Effects of an intensive 12-wk training program by elite swimmers on neutrophil oxidative activity. Med Sci Sports Exerc. 1995 Apr;27(4):536-42.
PubMed 7791584Robson PJ, Blannin AK, Walsh NP, Castell LM, Gleeson M. Effects of exercise intensity, duration and recovery on in vitro neutrophil function in male athletes. Int J Sports Med. 1999 Feb;20(2):128-35. doi: 10.1055/s-2007-971106.
PubMed 10190775
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bovine Colostrum Supplementation on Neutrophil Function in Recreational Athletes
- ClinicalTrials.gov ID
- NCT06123910
- Acronym / sponsor ID
- JHDEZ/CE/010-1/2018
- Conditions
- Innate Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 9 Nov 2023 (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.
32 recreational athletes who will attend to the Grand Marathon in the nort west of Mexico, event that will be held on December 2, 2018 or 21k Trail to be held in April 2019 will be invited to the study. Participants will be informed about the study procedures through a consent informed. Participants will be randomly divided into two groups, 16 in the intervention group and 16 in the comparison group. The participants will be recreational athletes between 18 and 60 years old. They must have athletic experience of at least 3 years. The participants considered will be those who perform vigorous physical activity per week according to the criteria of the short version IPAQ instrument. Smoking subjects with food intolerances and allergies, cardiovascular history will be excluded. Patients who have had a respiratory infection symptom in the last two weeks will not be able to participate in the study. Participants who are consuming some type of food supplement will be excluded.
Two 18 ml of blood samples will be taken from the vein of the forearm by venipuncture of each participant, using K2EDTA tubes after and before supplementation period. Blood samples were taken before a corporal, aerobic and nutritional evaluations.
CB supplementation will begin 4 weeks prior to competition events. One group will consume 20 g of bovine colostrum daily in solution with water. The second group will consume a placebo product with a nutritional composition similar to the group with the treatment of bovine colostrum. Both groups should take the supplement before breakfast with empty stomach.
Detailed description
It is widely accepted that exercise provide important health benefits. However, vigorous or extenuate exercise can affect the correct function of the immune system. Athletes who perform extreme physical routines to improve their athletic performance can develop opportunistic infections. After 3 to 72 h of physical activity there is a phase called "open window for infection", which predispose to upper track respiratory infection (UTRI). URTI is the main cause of medical consultation in athletes with vigorous exercise practices.
Neutrophils are one of the most abundant leucocytes in blood; their phagocytic activity is essential to control bacterial infections. Recently, the interest in knowing the participation of these cells in the sport field is growing. Neutrophilia refers to a high concentration of neutrophils in blood, and this is a common condition after exercise. The controversial part is that vigorous exercise could limit some important functions, such as oxidative burst, degranulation and phagocytosis until 6 h after exercise. However, there are contradictory results in this topic.
To alleviate those immunological alterations in athletes, a nutritional intervention should be included. Bovine colostrum has been evaluated as a supplement due to its potential immunomodulatory properties. It improves immunological parameters in individuals who achieve prolonged exercise sessions, allowing URTI reduction. Bovine colostrum is a yellow aqueous compound secreted by cow mammary glands the first 72 h after partum. Bovine colostrum contains anti-microbial peptides, enzymes, immunoglobulins, cytokines, microRNA and growth factors, which are able to modulate the immune system, at local (intestinal) and systemic level. Due to these characteristics, bovine colostrum has been used to improve the immune response under different physiological conditions.
A study showed that bovine colostrum supplementation induces a CD89 expression pre-exercise, after 5 weeks supplementation with 10 g of bovine colostrum. This result is important, since CD89 is a membrane receptor in neutrophils that recognize antibody/antigen complexes to prime phagocytosis and degranulation. In other study, 3 weeks of bovine colostrum supplementation improved neutrophil degranulation 1 h post-exercise in athletes, after 2 h of physical exercise. Authors evaluated neutrophil oxidative burst post-exercise after bovine colostrum supplementation, but no effects were observed. However, these authors found better oxidative burst after 4 weeks bovine colostrum supplementation. At this time, the effect of bovine colostrum in phagocytosis activity is unknown.
Concerning the effects of bovine colostrum supplementation in the URTI incidence, the results are contradictory. Although, others found no benefit in the incidence of URTI after a bovine colostrum supplementation, other studies showed promising results. A retrospective analysis conducted in 2003 showed a reduction of athletes with URTI in the bovine colostrum supplementation group. Likewise, another study reported less episodes and duration of infections in physically active subjects. Other studies described a tendency to decrease the incidence of URTI in swimmers and cyclists.
Study Design
A total of 28 athletes attending the "Hermosillo Grand Marathon" (December 2, 2018) and/or the "Hermosillo Half Marathon" (March 2019) will be part of this study. In this randomized clinical trial, study subjects will be randomly divided in two groups, 14 in the intervention group (bovine colostrum supplementation) and 14 in the comparison group (placebo supplementation). The participants will be recreational athletes between 18 and 60 years old. They must have athletic experience of at least 3 years and have to perform a vigorous physical activity per week according to the criteria of the short version IPAQ instrument. Smoking subjects, with food intolerances, allergies or cardiovascular history will not be included. Athletes with respiratory infection symptoms two weeks before beginning the supplementation won't be part of this protocol. Participants who are consuming some other type of food supplement will not be included. This protocol is currently under evaluation of the Ethics Committee of our institution. Participants will be informed about the study procedures and will sign an informed consent.
Bovine colostrum supplementation will begin 4 weeks prior to the competition event. The intervention group will consume 20 g of bovine colostrum, divided into two doses of 10 g/day. The first dose will be before breakfast and the second before lunch. The comparison group will consume a placebo product.
Two blood samples (24 ml of each one) will be taken from the vein of the forearm of each participant, using tubes with EDTA. The first sample will be taken before the competitive event after 10 min of a sitting rest. The second sample will be obtained immediately at the end of the test with 3 minutes of sitting rest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostrum bovine | Experimental | Dietary Supplement: Colostrum bovineSubjets taking a colostrum supplement |
| Placebo | Placebo comparator | Other: PlaceboSubjets taking a commercial dairy product |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- at least 3 years of training experience
- training for a half marathon competition
- No smokers
- Taking any kind of food supplements
- No alimentary allergies
Key exclusion criteria (4 listed)
- Injuries
- not follow experimental indications
- cardiovascular disease
- treatment intolerances
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 bovineAlso: sovereign laboratories colostrum ld powderColostrum bovine supplements, 25 kcal per portion, containing 0.25 g fats, 2.0 g CHO and 3 g protein. Lactose reduced. | Dietary supplement | Colostrum bovine |
| PlaceboAlso: Milk powderDairy comercial product. 25 kcal per portion, 1.3 g fats, 1.95 CHO and 1.3 protein. Lactose based. | Other | Placebo |
Primary outcome
Neutrophil phagocytic capacity
Time frame: Before and after 4 weeks of supplementation
Percentage of phagocytic neutrophils
Monocytes phagocytic capacity
Time frame: Before and after 4 weeks of supplementation
Percentage of phagocytic monocytes
neutrophils producing reactive oxygen species
Time frame: before and after 4 weeks of supplementation
percentage of positive cells to fluorescence intensity by flow cytometry
neutrophils reactive oxygen species production intensity
Time frame: Before and after 4 weeks of supplementation
Mean intensity fluorescent by cells measured by flow cytometry
Monocytes producing reactive oxygen species
Time frame: before and after 4 weeks of supplementation
percentage of positive cells to fluorescence intensity by flow cytometry
Monocytes reactive oxygen species production intensity
Time frame: Before and after 4 weeks of supplementation
Mean intensity fluorescent by cells measured by flow cytometry
VO2Max
Time frame: Before and after 4 weeks of supplementation
Indicates participants aerobic condition (ml/kg/min)
Days presenting upper respiratory tract symptoms
Time frame: During supplementation 4 weeks of supplementation
Total of days that participants refers any kind of upper respiratory symptoms
6 secondary outcomes
Weight
Time frame: before and after 4 weeks of supplementation
Height
Time frame: before and after 4 weeks of supplementation
Body fat
Time frame: before and after 4 weeks of supplementation
Fat free mass
Time frame: before and after 4 weeks of supplementation
Energy consumption
Time frame: before, after 2 and 4 weeks of supplementation
Macronutrient consumption
Time frame: before, after 2 weeks and 4 weeks of supplementation
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 9 Nov 2023.
- Background: PubMed 23540172Hackney AC, Koltun KJ. The immune system and overtraining in athletes: clinical implications. Acta Clin Croat. 2012 Dec;51(4):633-41.
- Background: PubMed 15673097Li TL, Gleeson M. The effect of single and repeated bouts of prolonged cycling on leukocyte redistribution, neutrophil degranulation, IL-6, and plasma stress hormone responses. Int J Sport Nutr Exerc Metab. 2004 Oct;14(5):501-16. doi: 10.1123/ijsnem.14.5.501.
- Background: PubMed 15633591Peake J, Suzuki K. Neutrophil activation, antioxidant supplements and exercise-induced oxidative stress. Exerc Immunol Rev. 2004;10:129-41.
- Background: PubMed 29511657Tritto ACC, Amano MT, De Cillo ME, Oliveira VA, Mendes SH, Yoshioka C, Roschel H, Camara NOS, Gualano B, Artioli GG. Effect of rapid weight loss and glutamine supplementation on immunosuppression of combat athletes: a double-blind, placebo-controlled study. J Exerc Rehabil. 2018 Feb 26;14(1):83-92. doi: 10.12965/jer.1835154.577. eCollection 2018 Feb.
- Background: PubMed 28224969Bermon S, Castell LM, Calder PC, Bishop NC, Blomstrand E, Mooren FC, Kruger K, Kavazis AN, Quindry JC, Senchina DS, Nieman DC, Gleeson M, Pyne DB, Kitic CM, Close GL, Larson-Meyer DE, Marcos A, Meydani SN, Wu D, Walsh NP, Nagatomi R. Consensus Statement Immunonutrition and Exercise. Exerc Immunol Rev. 2017;23:8-50.
- Background: PubMed 25727914Jones AW, Thatcher R, March DS, Davison G. Influence of 4 weeks of bovine colostrum supplementation on neutrophil and mucosal immune responses to prolonged cycling. Scand J Med Sci Sports. 2015 Dec;25(6):788-96. doi: 10.1111/sms.12433. Epub 2015 Feb 28.
- Background: PubMed 17095643Shing CM, Peake J, Suzuki K, Okutsu M, Pereira R, Stevenson L, Jenkins DG, Coombes JS. Effects of bovine colostrum supplementation on immune variables in highly trained cyclists. J Appl Physiol (1985). 2007 Mar;102(3):1113-22. doi: 10.1152/japplphysiol.00553.2006. Epub 2006 Nov 9.
- Background: PubMed 24571383Rathe M, Muller K, Sangild PT, Husby S. Clinical applications of bovine colostrum therapy: a systematic review. Nutr Rev. 2014 Apr;72(4):237-54. doi: 10.1111/nure.12089. Epub 2014 Feb 26.
- Background: PubMed 16676703Crooks CV, Wall CR, Cross ML, Rutherfurd-Markwick KJ. The effect of bovine colostrum supplementation on salivary IgA in distance runners. Int J Sport Nutr Exerc Metab. 2006 Feb;16(1):47-64. doi: 10.1123/ijsnem.16.1.47.
- Results publication: PubMed 28756389Soligard T, Steffen K, Palmer D, Alonso JM, Bahr R, Lopes AD, Dvorak J, Grant ME, Meeuwisse W, Mountjoy M, Pena Costa LO, Salmina N, Budgett R, Engebretsen L. Sports injury and illness incidence in the Rio de Janeiro 2016 Olympic Summer Games: A prospective study of 11274 athletes from 207 countries. Br J Sports Med. 2017 Sep;51(17):1265-1271. doi: 10.1136/bjsports-2017-097956. Epub 2017 Jul 29.
- Results publication: PubMed 25425714Palmer-Green D, Elliott N. Sports injury and illness epidemiology: Great Britain Olympic Team (TeamGB) surveillance during the Sochi 2014 Winter Olympic Games. Br J Sports Med. 2015 Jan;49(1):25-9. doi: 10.1136/bjsports-2014-094206. Epub 2014 Nov 25.
- Results publication: PubMed 1618188McCarthy DA, Macdonald I, Grant M, Marbut M, Watling M, Nicholson S, Deeks JJ, Wade AJ, Perry JD. Studies on the immediate and delayed leucocytosis elicited by brief (30-min) strenuous exercise. Eur J Appl Physiol Occup Physiol. 1992;64(6):513-7. doi: 10.1007/BF00843760.
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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.
Jesús Hernández, PhD principal investigator
Centro de Investigación en Alimentación y Desarrollo A.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colostrum bovine in people with Innate Immunity, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 1 site in Mexico.
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 9 Nov 2023. 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 Mexico. 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.
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?
Neutrophil phagocytic capacity (time frame: Before and after 4 weeks of supplementation). The study lists 8 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 NCT06123910, which also lists 18 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 9 Nov 2023.