The Effect of 8-weeks of Bovine Colostrum and Soy Protein Supplementation in Rugby Players
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedNovember 1, 2016
October 1, 2016
8 months
December 1, 2014
October 30, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
Change in lean tissue mass
baseline, 8 weeks
Change in leg press strength
baseline, 8 weeks
Change in bench press strength
baseline, 8 weeks
Change in aerobic capacity as predicted by the Leger shuttle run test
baseline, 8 weeks
Change in leg power as assessed by vertical jump height
baseline, 8 weeks
Secondary Outcomes (6)
Change in salivary immunoglobulin A
baseline, 8 weeks
Change in salivary interleukin 6
baseline, 8 weeks
Change in salivary interleukin 1-beta
baseline, 8 weeks
Change in salivary c-reactive protein
baseline, 8 weeks
Incidence of upper respiratory tract infections
Up to 8 weeks
- +1 more secondary outcomes
Study Arms (2)
Bovine colostrum
EXPERIMENTAL8 weeks of Bovine colostrum power, 60g per day
Soy powder
ACTIVE COMPARATOR8 weeks of Soy powder, 60g per day
Interventions
Eligibility Criteria
You may qualify if:
- active rugby players
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5B2, Canada
Related 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.
PMID: 24281841BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Chilibeck, PhD
University of Saskatchewan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
December 1, 2014
First Posted
November 1, 2016
Study Start
December 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
November 1, 2016
Record last verified: 2016-10