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The Effect of Bovine Colostrum Supplementation in Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01792297
First Posted: February 15, 2013
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mitacs
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan
  Purpose

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.

Condition Intervention
Sarcopenia Osteoporosis Dietary Supplement: Bovine colostrum Dietary Supplement: Whey protein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Bovine Colostrum Supplementation in Older Adults

Further study details as provided by Phil Chilibeck, University of Saskatchewan:

Primary Outcome 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 Outcome 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


Enrollment: 40
Study Start Date: December 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792297


Locations
Canada, Saskatchewan
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5B2
Sponsors and Collaborators
University of Saskatchewan
Mitacs
Investigators
Principal Investigator: Philip D Chilibeck, PhD University of Saskatchewan
  More Information

Publications:
Responsible Party: Phil Chilibeck, Ph.D., University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01792297     History of Changes
Other Study ID Numbers: 12-255
First Submitted: February 4, 2013
First Posted: February 15, 2013
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Phil Chilibeck, University of Saskatchewan:
Sarcopenia
Osteoporosis
Cognition
Inflammation

Additional relevant MeSH terms:
Osteoporosis
Sarcopenia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms