Clinical trial NCT01792297: The Effect of Bovine Colostrum Supplementation in Older Adults
Official title: The Effect of Bovine Colostrum Supplementation in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Osteoporosis
Keywords: Sarcopenia
Osteoporosis
Cognition
Inflammation
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Mitacs
First posted: 2013-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Men or women 50 y or older

Exclusion Criteria:

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

Primary outcomes:
measure: change from baseline in lean tissue mass at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in Upper body strength at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in Lower body strength at 8 weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change from baseline in Insulin like growth factor-1 at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in upper body muscle thickness at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in lower body muscle thickness at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in muscle catabolism at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in bone catabolism at 8 weeks
timeFrame: Baseline and 8 weeks
measure: 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
timeFrame: continuously throughout 8 weeks
measure: Change from baseline in inflammation at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in cognitive ability at 8 weeks
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Kinesiology, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip D Chilibeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.