NCT02951923

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

December 1, 2014

Last Update Submit

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

EXPERIMENTAL

8 weeks of Bovine colostrum power, 60g per day

Dietary Supplement: Bovine Colostrum

Soy powder

ACTIVE COMPARATOR

8 weeks of Soy powder, 60g per day

Dietary Supplement: Soy

Interventions

Bovine ColostrumDIETARY_SUPPLEMENT

Bovine colostrum vs. soy during rugby training

Bovine colostrum
SoyDIETARY_SUPPLEMENT
Soy powder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

  • Philip Chilibeck, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

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

Locations