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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02951923
Other study ID # BIO14-81
Secondary ID
Status Completed
Phase N/A
First received December 1, 2014
Last updated October 30, 2016
Start date December 2014
Est. completion date August 2015

Study information

Verified date October 2016
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Bovine Colostrum
Bovine colostrum vs. soy during rugby training
Soy


Locations

Country Name City State
Canada College of Kinesiology, University of Saskatchewan Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in lean tissue mass baseline, 8 weeks No
Primary Change in leg press strength baseline, 8 weeks No
Primary Change in bench press strength baseline, 8 weeks No
Primary Change in aerobic capacity as predicted by the Leger shuttle run test baseline, 8 weeks No
Primary Change in leg power as assessed by vertical jump height baseline, 8 weeks No
Secondary Change in salivary immunoglobulin A baseline, 8 weeks No
Secondary Change in salivary interleukin 6 baseline, 8 weeks No
Secondary Change in salivary interleukin 1-beta baseline, 8 weeks No
Secondary Change in salivary c-reactive protein baseline, 8 weeks No
Secondary Incidence of upper respiratory tract infections Up to 8 weeks No
Secondary Adverse events Up to 8 weeks Yes
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