SarcopeniaNCT01792297
The Effect of Bovine Colostrum Supplementation in Older Adults
A study testing Bovine colostrum and Whey protein in people with Sarcopenia and Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Osteoporosis
- What is being tested?
- Bovine colostrum and Whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women 50 y or older
Who cannot join
- Milk allergies
- Contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5B2
About this study
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.
- Conditions
- Sarcopenia, Osteoporosis
- Being tested
- Bovine colostrum, Whey protein
- Keywords
- Sarcopenia, Osteoporosis, Cognition, Inflammation
- Medical subject headings
- Sarcopenia, Osteoporosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine colostrumDietary supplement
Whey proteinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Bovine Colostrum | Experimental | 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) Receives: Dietary Supplement: Bovine colostrum |
| Whey protein | Active comparator | 60 g/d whey protein powder mixed into drinks. It is to be divided into 3 daily doses (20 g per dose) Receives: Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in lean tissue mass at 8 weeks
Lean tissue mass assessed by dual energy x-ray absorptiometry
Measured: baseline and 8 weeks
Change from baseline in Upper body strength at 8 weeks
Bench Press Strength
Measured: baseline and 8 weeks
Change from baseline in Lower body strength at 8 weeks
Leg press strength
Measured: baseline and 8 weeks
Secondary outcomes (8)
Change from baseline in Insulin like growth factor-1 at 8 weeks
IGF-1 from serum
Measured: baseline and 8 weeks
Change from baseline in upper body muscle thickness at 8 weeks
Muscle thickness of the elbow flexors assessed by ultrasound
Measured: baseline and 8 weeks
Change from baseline in lower body muscle thickness at 8 weeks
Knee extensors muscle thickness assessed by ultrasound
Measured: baseline and 8 weeks
Change from baseline in muscle catabolism at 8 weeks
Urinary 3-methylhistidine levels
Measured: baseline and 8 weeks
Change from baseline in bone catabolism at 8 weeks
Urinary cross-linked N-telopeptides of type I collagen
Measured: 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
Measured: continuously throughout 8 weeks
Change from baseline in inflammation at 8 weeks
Serum cytokine markers of inflammation (IL-6 and TNF-alpha)
Measured: baseline and 8 weeks
Change from baseline in cognitive ability at 8 weeks
The Telephone Interview of Cognitive Status
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip D Chilibeck, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792297
- Sponsor's protocol ID
- 12-255
- Status last verified
- May 2017
- First submitted
- 4 Feb 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/s0899-9007(00)00552-9.
PubMed 11312068Kerksick 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. doi: 10.1016/j.nut.2007.06.015.
PubMed 17679046
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bovine Colostrum Supplementation in Older Adults
- ClinicalTrials.gov ID
- NCT01792297
- Acronym / sponsor ID
- 12-255
- Conditions
- Sarcopenia, Osteoporosis
- Keywords
- Sarcopenia, Osteoporosis, Cognition, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bovine Colostrum | Experimental | Dietary Supplement: Bovine colostrum60 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) |
| Whey protein | Active comparator | Dietary Supplement: Whey protein60 g/d whey protein powder mixed into drinks. It is to be divided into 3 daily doses (20 g per dose) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or women 50 y or older
Key exclusion criteria (2 listed)
- Milk allergies
- Contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine colostrum | Dietary supplement | Bovine Colostrum |
| Whey protein | Dietary supplement | Whey protein |
Primary outcome
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
8 secondary outcomes
Change from baseline in Insulin like growth factor-1 at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in upper body muscle thickness at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in lower body muscle thickness at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in muscle catabolism at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in bone catabolism at 8 weeks
Time frame: 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
Time frame: continuously throughout 8 weeks
Change from baseline in inflammation at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in cognitive ability at 8 weeks
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 11312068Antonio 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. doi: 10.1016/s0899-9007(00)00552-9.
- Background: PubMed 17679046Kerksick 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. doi: 10.1016/j.nut.2007.06.015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip D Chilibeck, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine colostrum and Whey protein in people with Sarcopenia and Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in lean tissue mass at 8 weeks (time frame: baseline and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.