- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02951923
The Effect of 8-weeks of Bovine Colostrum and Soy Protein Supplementation in Rugby Players
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology, University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Bovine colostrum
8 weeks of Bovine colostrum power, 60g per day
|
Bovine colostrum vs. soy during rugby training
|
|
ACTIVE_COMPARATOR: Soy powder
8 weeks of Soy powder, 60g per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in lean tissue mass
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Change in leg press strength
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Change in bench press strength
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Change in aerobic capacity as predicted by the Leger shuttle run test
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Change in leg power as assessed by vertical jump height
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in salivary immunoglobulin A
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Change in salivary interleukin 6
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Change in salivary interleukin 1-beta
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Change in salivary c-reactive protein
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
|
Incidence of upper respiratory tract infections
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
|
Adverse events
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BIO14-81
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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