The Effect of Bovine Colostrum Supplementation in Older Adults

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 Overview

• Status: Completed
• Conditions: Sarcopenia; Osteoporosis
• Intervention / Treatment: Dietary supplement: Bovine colostrum; Dietary supplement: Whey protein

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5B2
      • College of Kinesiology, University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women 50 y or older

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)	Dietary supplement: Whey protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in lean tissue mass at 8 weeks	Lean tissue mass assessed by dual energy x-ray absorptiometry	baseline and 8 weeks
Change from baseline in Upper body strength at 8 weeks	Bench Press Strength	baseline and 8 weeks
Change from baseline in Lower body strength at 8 weeks	Leg press strength	baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Insulin like growth factor-1 at 8 weeks	IGF-1 from serum	baseline and 8 weeks
Change from baseline in upper body muscle thickness at 8 weeks	Muscle thickness of the elbow flexors assessed by ultrasound	baseline and 8 weeks
Change from baseline in lower body muscle thickness at 8 weeks	Knee extensors muscle thickness assessed by ultrasound	baseline and 8 weeks
Change from baseline in muscle catabolism at 8 weeks	Urinary 3-methylhistidine levels	baseline and 8 weeks
Change from baseline in bone catabolism at 8 weeks	Urinary cross-linked N-telopeptides of type I collagen	Baseline and 8 weeks
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	Adverse events collected on adverse event forms	continuously throughout 8 weeks
Change from baseline in inflammation at 8 weeks	Serum cytokine markers of inflammation (IL-6 and TNF-alpha)	baseline and 8 weeks
Change from baseline in cognitive ability at 8 weeks	The Telephone Interview of Cognitive Status	baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Mitacs
• Investigators: Principal Investigator: Philip D Chilibeck, PhD, University of Saskatchewan

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0899-9007(00)00552-9.
• 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. doi: 10.1016/j.nut.2007.06.015.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Inflammation; Cognition; Sarcopenia; Osteoporosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Bone Diseases; Muscular Atrophy; Atrophy; Bone Diseases, Metabolic; Sarcopenia; Osteoporosis
• Other Study ID Numbers: 12-255