The Effect of Bovine Colostrum Supplementation in Older Adults

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2013

Interventions

  • Dietary Supplement: Bovine colostrum
  • Dietary Supplement: Whey protein

Arms, Groups and Cohorts

  • 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)
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Men or women 50 y or older Exclusion Criteria:

  • Milk allergies – Contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Saskatchewan
  • Collaborator
    • Mitacs
  • Provider of Information About this Clinical Study
    • Principal Investigator: Phil Chilibeck, Ph.D. – University of Saskatchewan
  • Overall Official(s)
    • Philip D Chilibeck, PhD, Principal Investigator, University of Saskatchewan

References

Antonio J, Sanders MS, Van Gammeren D. The effects of bovine colostrum supplementation on body composition and exercise performance in active men and women. Nutrition. 2001 Mar;17(3):243-7.

Kerksick CM, Rasmussen C, Lancaster S, Starks M, Smith P, Melton C, Greenwood M, Almada A, Kreider R. Impact of differing protein sources and a creatine containing nutritional formula after 12 weeks of resistance training. Nutrition. 2007 Sep;23(9):647-56.

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