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Completed

NCT Number: NCT01792297

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.

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Key information

Conditions

Sarcopenia Atrophy Bone Diseases Bone Diseases, Metabolic Inflammation Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteoporosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women 50 y or older

Exclusion criteria

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

Treatment and study plan

Bovine colostrum

Dietary Supplement

Whey Protein

Dietary Supplement

Primary outcomes

  1. 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

  2. Change from baseline in Upper body strength at 8 weeks

    Time frame: baseline and 8 weeks

    Bench Press Strength

  3. Change from baseline in Lower body strength at 8 weeks

    Time frame: baseline and 8 weeks

    Leg press strength

Secondary outcomes

  1. Change from baseline in Insulin like growth factor-1 at 8 weeks

    Time frame: baseline and 8 weeks

    IGF-1 from serum

  2. 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

  3. Change from baseline in lower body muscle thickness at 8 weeks

    Time frame: baseline and 8 weeks

    Knee extensors muscle thickness assessed by ultrasound

  4. Change from baseline in muscle catabolism at 8 weeks

    Time frame: baseline and 8 weeks

    Urinary 3-methylhistidine levels

  5. Change from baseline in bone catabolism at 8 weeks

    Time frame: Baseline and 8 weeks

    Urinary cross-linked N-telopeptides of type I collagen

  6. 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

  7. Change from baseline in inflammation at 8 weeks

    Time frame: baseline and 8 weeks

    Serum cytokine markers of inflammation (IL-6 and TNF-alpha)

  8. Change from baseline in cognitive ability at 8 weeks

    Time frame: baseline and 8 weeks

    The Telephone Interview of Cognitive Status

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Mitacs

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2013
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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