Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06123910
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-10-16
Brief Title:
Bovine Colostrum Supplementation in Athletes
Sponsor:
Centro de Investigación en Alimentación y Desarrollo AC
Organization:
Centro de Investigación en Alimentación y Desarrollo AC
Study Overview
Official Title:
Effect of Bovine Colostrum Supplementation on Neutrophil Function in Recreational Athletes
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 antibodyantigen 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 andor 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 wont 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 gday 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
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 antibodyantigen 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 andor 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 wont 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 gday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None