The Effect of Bovine Colostrum Supplementation in Older Adults

Osteoporosis Clinical Trial

Official title:

The Effect of Bovine Colostrum Supplementation in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792297
• Other study ID #: 12-255
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: May 2, 2017
• Start date: December 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2017
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Men or women 50 y or older

Exclusion Criteria:

• Milk allergies

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

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Intervention

Dietary Supplement:
• Bovine colostrum

• Whey protein

Locations

Country	Name	City	State
Canada	College of Kinesiology, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Mitacs

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in lean tissue mass at 8 weeks	Lean tissue mass assessed by dual energy x-ray absorptiometry	baseline and 8 weeks
Primary	Change from baseline in Upper body strength at 8 weeks	Bench Press Strength	baseline and 8 weeks
Primary	Change from baseline in Lower body strength at 8 weeks	Leg press strength	baseline and 8 weeks
Secondary	Change from baseline in Insulin like growth factor-1 at 8 weeks	IGF-1 from serum	baseline and 8 weeks
Secondary	Change from baseline in upper body muscle thickness at 8 weeks	Muscle thickness of the elbow flexors assessed by ultrasound	baseline and 8 weeks
Secondary	Change from baseline in lower body muscle thickness at 8 weeks	Knee extensors muscle thickness assessed by ultrasound	baseline and 8 weeks
Secondary	Change from baseline in muscle catabolism at 8 weeks	Urinary 3-methylhistidine levels	baseline and 8 weeks
Secondary	Change from baseline in bone catabolism at 8 weeks	Urinary cross-linked N-telopeptides of type I collagen	Baseline and 8 weeks
Secondary	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
Secondary	Change from baseline in inflammation at 8 weeks	Serum cytokine markers of inflammation (IL-6 and TNF-alpha)	baseline and 8 weeks
Secondary	Change from baseline in cognitive ability at 8 weeks	The Telephone Interview of Cognitive Status	baseline and 8 weeks