The Effect of Bovine Colostrum Supplementation in Older Adults

This study has been completed.
Sponsor:
Collaborator:
MITACS
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01792297
First received: February 4, 2013
Last updated: December 10, 2013
Last verified: December 2012
  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 Phase
Sarcopenia
Osteoporosis
Dietary Supplement: Bovine colostrum
Dietary Supplement: Whey protein
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Bovine Colostrum Supplementation in Older Adults

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • change from baseline in lean tissue mass at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Bench Press Strength

  • Change from baseline in Lower body strength at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    Leg press strength


Secondary Outcome Measures:
  • Change from baseline in Insulin like growth factor-1 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    IGF-1 from serum

  • Change from baseline in upper body muscle thickness at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Knee extensors muscle thickness assessed by ultrasound

  • Change from baseline in muscle catabolism at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    Urinary 3-methylhistidine levels

  • Change from baseline in bone catabolism at 8 weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Adverse events collected on adverse event forms

  • Change from baseline in inflammation at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01792297     History of Changes
Other Study ID Numbers: 12-255
Study First Received: February 4, 2013
Last Updated: December 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Sarcopenia
Osteoporosis
Cognition
Inflammation

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

ClinicalTrials.gov processed this record on July 31, 2014