We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of 8-weeks of Bovine Colostrum and Soy Protein Supplementation in Rugby Players

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951923
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE November 1, 2016
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2016)
  • Change in lean tissue mass [ Time Frame: baseline, 8 weeks ]
  • Change in leg press strength [ Time Frame: baseline, 8 weeks ]
  • Change in bench press strength [ Time Frame: baseline, 8 weeks ]
  • Change in aerobic capacity as predicted by the Leger shuttle run test [ Time Frame: baseline, 8 weeks ]
  • Change in leg power as assessed by vertical jump height [ Time Frame: baseline, 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2016)
  • Change in salivary immunoglobulin A [ Time Frame: baseline, 8 weeks ]
  • Change in salivary interleukin 6 [ Time Frame: baseline, 8 weeks ]
  • Change in salivary interleukin 1-beta [ Time Frame: baseline, 8 weeks ]
  • Change in salivary c-reactive protein [ Time Frame: baseline, 8 weeks ]
  • Incidence of upper respiratory tract infections [ Time Frame: Up to 8 weeks ]
  • Adverse events [ Time Frame: Up to 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of 8-weeks of Bovine Colostrum and Soy Protein Supplementation in Rugby Players
Official Title  ICMJE The Effect of 8-weeks of Bovine Colostrum and Soy Protein Supplementation on Fitness, Muscle Mass, Inflammation and Immune Function During Intense Training in Rugby Players
Brief Summary Bovine colostrum is the milk produced by cows immediately after calving. It contains high levels of proteins that improve immune protection and may act to prevent colds. During intense training, athletes often have compromised immune function. This may be especially true in club-level rugby players who abruptly start high intensity training in the spring in preparation for their competitive season. Our study will assess the effects of supplementing these players with bovine colostrum during this intense training. Thirty-six players will be recruited; half will consume colostrum during the 8 weeks of early-season training and half soy protein. The investigators predict the bovine colostrum supplement will improve health during the training and increase fitness levels.
Detailed Description

Bovine colostrum is the first milk secreted by cows after calving. Colostrum is high in protein and contains a number of bioactive substances including growth and antimicrobial factors. Antimicrobial factors in bovine colostrum include immunoglobulin and a variety of other less specific antimicrobial proteins and peptides. Immunoglobulin and other antimicrobials are important for immune system function. This is important to athletes because intense exercise training can compromise the immune system; therefore bovine colostrum has potential to improve exercise performance by preventing immune system dysfunction that is common during periods of heavy exercise training .

Preliminary studies of colostrum supplementation show its potential for increasing human exercise performance. The mechanism through which colostrum acts to benefit performance remains unclear. Similarly, further studies are required to elucidate colostrum-induced effects in individuals of different ages and levels/intensity of physical activity.

The main growth factor in bovine colostrum is insulin-like growth factor-1 (IGF-1). Bovine colostrum supplementation in young individuals increased IGF-1 levels. Insulin-like growth factor-1 stimulates growth of muscle tissue and is important in maintaining muscle mass and function in adults.

Bovine colostrum supplementation has been shown to increase lean tissue (muscle mass) in younger individuals. Eight to 12 weeks of bovine colostrum supplementation during a resistance training program increased lean tissue mass by 1.5 to 2 kg compared to increases of 0 to 1.2 kg while on whey protein supplementation. We have also recently shown that bovine colostrum supplementation increases muscular strength compared to similar amounts of supplementation with whey protein in men and women over 50y.

Examining the effects of colostrum in rugby players presents a unique scientific opportunity because of the nature of their training regime. Rugby players' early season workouts are the most stressful training sessions of the season (after the winter break they must condition quickly for the start of the season with few if any pre-season games and their workouts involve repeated sprint activity in addition to weight training). Rugby players would be most susceptible to overtraining and immune system depression during this time of the year. Bovine colostrum with its high levels of anti-microbials and other bioactive factors may be beneficial to mitigate the deleterious effects of early, high intensity training.

The objective of the proposed internship study is to determine the effects of 8 weeks of bovine colostrum supplementation, compared to soy protein supplementation in rugby players during early season training.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Exercise Performance
  • Body Composition
Intervention  ICMJE
  • Dietary Supplement: Bovine Colostrum
    Bovine colostrum vs. soy during rugby training
  • Dietary Supplement: Soy
Study Arms  ICMJE
  • Experimental: Bovine colostrum
    8 weeks of Bovine colostrum power, 60g per day
    Intervention: Dietary Supplement: Bovine Colostrum
  • Active Comparator: Soy powder
    8 weeks of Soy powder, 60g per day
    Intervention: Dietary Supplement: Soy
Publications * Duff WR, Chilibeck PD, Rooke JJ, Kaviani M, Krentz JR, Haines DM. The effect of bovine colostrum supplementation in older adults during resistance training. Int J Sport Nutr Exerc Metab. 2014 Jun;24(3):276-85. doi: 10.1123/ijsnem.2013-0182. Epub 2013 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • active rugby players

Exclusion Criteria:

  • Not taking nutritional supplements within one month of the study
  • Answered "yes" to a physical activity readiness questionnaire indicating health problems that could be exacerbated with physical activity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02951923
Other Study ID Numbers  ICMJE BIO14-81
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Phil Chilibeck, University of Saskatchewan
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Saskatchewan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Chilibeck, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP