Bovine Colostrum Supplementation in Athletes

NCT06123910 | Completed DMC

• 1 other identifier: JHDEZ/CE/010-1/2018
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Innate Immunity

Outcome Measures

Primary Outcomes (8)

• Neutrophil phagocytic capacity

  Percentage of phagocytic neutrophils

  Before and after 4 weeks of supplementation

• Monocytes phagocytic capacity

  Percentage of phagocytic monocytes

  Before and after 4 weeks of supplementation

• neutrophils producing reactive oxygen species

  percentage of positive cells to fluorescence intensity by flow cytometry

  before and after 4 weeks of supplementation

• neutrophils reactive oxygen species production intensity

  Mean intensity fluorescent by cells measured by flow cytometry

  Before and after 4 weeks of supplementation

• Monocytes producing reactive oxygen species

  percentage of positive cells to fluorescence intensity by flow cytometry

  before and after 4 weeks of supplementation

• Monocytes reactive oxygen species production intensity

  Mean intensity fluorescent by cells measured by flow cytometry

  Before and after 4 weeks of supplementation

• VO2Max

  Indicates participants aerobic condition (ml/kg/min)

  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

  During supplementation 4 weeks of supplementation

Secondary Outcomes (6)

• Weight

  before and after 4 weeks of supplementation

• Height

  before and after 4 weeks of supplementation

• Body fat

  before and after 4 weeks of supplementation

• Fat free mass

  before and after 4 weeks of supplementation

• Energy consumption

  before, after 2 and 4 weeks of supplementation

Study Arms (2)

Colostrum bovine

EXPERIMENTAL

Subjets taking a colostrum supplement

Dietary Supplement: Colostrum bovine

Placebo

PLACEBO COMPARATOR

Subjets taking a commercial dairy product

Other: Placebo

Interventions

Colostrum bovine DIETARY_SUPPLEMENT

Colostrum bovine supplements, 25 kcal per portion, containing 0.25 g fats, 2.0 g CHO and 3 g protein. Lactose reduced.

Also known as: sovereign laboratories colostrum ld powder

Colostrum bovine

Placebo OTHER

Dairy comercial product. 25 kcal per portion, 1.3 g fats, 1.95 CHO and 1.3 protein. Lactose based.

Also known as: Milk powder

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• at least 3 years of training experience
• training for a half marathon competition
• No smokers
• Taking any kind of food supplements
• No alimentary allergies

You may not qualify if:

• Injuries
• not follow experimental indications
• cardiovascular disease
• treatment intolerances

Sponsors & Collaborators

• Centro de Investigación en Alimentación y Desarrollo A.C.: lead

Study Sites (1)

Centro de Investigación en Alimentación y Desarrollo

Hermosillo, Sonora, 83304, Mexico

Location

Related Publications (18)

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  PMID: 23540172 BACKGROUND

• Li 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.

  PMID: 15673097 BACKGROUND

• Peake J, Suzuki K. Neutrophil activation, antioxidant supplements and exercise-induced oxidative stress. Exerc Immunol Rev. 2004;10:129-41.

  PMID: 15633591 BACKGROUND

• Tritto 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.

  PMID: 29511657 BACKGROUND

• Bermon 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.

  PMID: 28224969 BACKGROUND

• Jones 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.

  PMID: 25727914 BACKGROUND

• Shing 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.

  PMID: 17095643 BACKGROUND

• Rathe 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.

  PMID: 24571383 BACKGROUND

• Crooks 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.

  PMID: 16676703 BACKGROUND

• Soligard 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.

  PMID: 28756389 RESULT

• Palmer-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.

  PMID: 25425714 RESULT

• McCarthy 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.

  PMID: 1618188 RESULT

• Davison 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.

  PMID: 20030905 RESULT

• Pyne 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.

  PMID: 7791584 RESULT

• Robson 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.

  PMID: 10190775 RESULT

• Santos VC, Levada-Pires AC, Alves SR, Pithon-Curi TC, Curi R, Cury-Boaventura MF. Changes in lymphocyte and neutrophil function induced by a marathon race. Cell Biochem Funct. 2013 Apr;31(3):237-43. doi: 10.1002/cbf.2877. Epub 2012 Sep 13.

  PMID: 22972482 RESULT

• Brinkworth GD, Buckley JD. Concentrated bovine colostrum protein supplementation reduces the incidence of self-reported symptoms of upper respiratory tract infection in adult males. Eur J Nutr. 2003 Aug;42(4):228-32. doi: 10.1007/s00394-003-0410-x.

  PMID: 12923655 RESULT

• Crooks C, Cross ML, Wall C, Ali A. Effect of bovine colostrum supplementation on respiratory tract mucosal defenses in swimmers. Int J Sport Nutr Exerc Metab. 2010 Jun;20(3):224-35. doi: 10.1123/ijsnem.20.3.224.

  PMID: 20601740 RESULT

MeSH Terms

Interventions

Refit milk powder

Study Officials

• Jesús Hernández, PhD

  Centro de Investigación en Alimentación y Desarrollo A.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 9, 2023
• Study Start: October 10, 2018
• Primary Completion: November 13, 2018
• Study Completion: April 5, 2019
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

ME (1)