The Effect of Bovine Colostrum Supplementation in Older Adults

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Bovine Colostrum Supplementation in Older Adults

Conditions
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Sarcopenia, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Bovine colostrum
* Dietary Supplement: Whey protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 50 y or older Exclusion Criteria: Milk allergies Contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bovine Colostrum<br>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<br> <br> |
| Active Comparator: Whey protein<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in lean tissue mass at 8 weeks | Lean tissue mass assessed by dual energy x-ray absorptiometry | baseline and 8 weeks | 
| Change from baseline in Upper body strength at 8 weeks | Bench Press Strength | baseline and 8 weeks | 
| Change from baseline in Lower body strength at 8 weeks | Leg press strength | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Insulin like growth factor-1 at 8 weeks | IGF-1 from serum | baseline and 8 weeks | 
| Change from baseline in upper body muscle thickness at 8 weeks | Muscle thickness of the elbow flexors assessed by ultrasound | baseline and 8 weeks | 
| Change from baseline in lower body muscle thickness at 8 weeks | Knee extensors muscle thickness assessed by ultrasound | baseline and 8 weeks | 
| Change from baseline in muscle catabolism at 8 weeks | Urinary 3-methylhistidine levels | baseline and 8 weeks | 
| Change from baseline in bone catabolism at 8 weeks | Urinary cross-linked N-telopeptides of type I collagen | Baseline and 8 weeks | 
| 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 | 
| Change from baseline in inflammation at 8 weeks | Serum cytokine markers of inflammation (IL-6 and TNF-alpha) | baseline and 8 weeks | 
| Change from baseline in cognitive ability at 8 weeks | The Telephone Interview of Cognitive Status | baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Osteoporosis, Cognition, Inflammation