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The Effect of Bovine Colostrum Supplementation in Older Adults

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ClinicalTrials.gov Identifier: NCT01792297
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Mitacs
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE February 4, 2013
First Posted Date  ICMJE February 15, 2013
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE December 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
  • change from baseline in lean tissue mass at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Lean tissue mass assessed by dual energy x-ray absorptiometry
  • Change from baseline in Upper body strength at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Bench Press Strength
  • Change from baseline in Lower body strength at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Leg press strength
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01792297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
  • Change from baseline in Insulin like growth factor-1 at 8 weeks [ Time Frame: baseline and 8 weeks ]
    IGF-1 from serum
  • Change from baseline in upper body muscle thickness at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Muscle thickness of the elbow flexors assessed by ultrasound
  • Change from baseline in lower body muscle thickness at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Knee extensors muscle thickness assessed by ultrasound
  • Change from baseline in muscle catabolism at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Urinary 3-methylhistidine levels
  • Change from baseline in bone catabolism at 8 weeks [ Time Frame: Baseline and 8 weeks ]
    Urinary cross-linked N-telopeptides of type I collagen
  • Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: continuously throughout 8 weeks ]
    Adverse events collected on adverse event forms
  • Change from baseline in inflammation at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Serum cytokine markers of inflammation (IL-6 and TNF-alpha)
  • Change from baseline in cognitive ability at 8 weeks [ Time Frame: baseline and 8 weeks ]
    The Telephone Interview of Cognitive Status
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 Bovine Colostrum Supplementation in Older Adults
Official Title  ICMJE The Effect of Bovine Colostrum Supplementation in Older Adults
Brief Summary

Bovine colostrum is the initial milk secreted by cows during the first day after calving. Colostrum is high in protein and contains a number of substances that have potential to be beneficial for the immune system. Preliminary studies about effects of colostrum supplementation show its potential for increasing human exercise performance; however, more evidence across the lifespan is required to confirm effects and to understand mechanisms of action. The objectives are to determine the effect of 8 weeks of bovine colostrum supplementation, compared to whey protein supplementation on the following dependent variables in men and women 50 years and older while participating in a resistance-training program:

  • muscle mass
  • strength
  • blood levels of growth factors and markers of inflammation
  • urine levels of muscle and bone catabolic markers
  • tests of cognitive ability It is hypothesized that bovine colostrum supplementation will result in greater increases in muscle mass, strength, blood IGF-1 levels (an anabolic hormone), and cognitive ability, and greater reductions in inflammation, and markers of muscle and bone catabolism, compared to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Sarcopenia
  • Osteoporosis
Intervention  ICMJE
  • Dietary Supplement: Bovine colostrum
  • Dietary Supplement: Whey protein
Study Arms  ICMJE
  • Experimental: Bovine Colostrum
    60 g/d bovine colostrum in powder form to be mixed with drinks. The dose will be spread out 3 times per day (20 g per dose)
    Intervention: Dietary Supplement: Bovine colostrum
  • Active Comparator: Whey protein
    60 g/d whey protein powder mixed into drinks. It is to be divided into 3 daily doses (20 g per dose)
    Intervention: Dietary Supplement: Whey protein
Publications *

*   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: February 12, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women 50 y or older

Exclusion Criteria:

  • Milk allergies
  • Contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 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 NCT01792297
Other Study ID Numbers  ICMJE 12-255
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phil Chilibeck, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Mitacs
Investigators  ICMJE
Principal Investigator: Philip D Chilibeck, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date May 2017

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