NCT01792297

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

February 4, 2013

Last Update Submit

May 2, 2017

Conditions

Keywords

SarcopeniaOsteoporosisCognitionInflammation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

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

    baseline and 8 weeks

  • Change from baseline in upper body muscle thickness at 8 weeks

    baseline and 8 weeks

  • Change from baseline in lower body muscle thickness at 8 weeks

    baseline and 8 weeks

  • Change from baseline in muscle catabolism at 8 weeks

    baseline and 8 weeks

  • Change from baseline in bone catabolism at 8 weeks

    Baseline and 8 weeks

  • +3 more secondary outcomes

Study Arms (2)

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)

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)

Dietary Supplement: Whey protein

Interventions

Bovine colostrumDIETARY_SUPPLEMENT
Bovine Colostrum
Whey proteinDIETARY_SUPPLEMENT
Whey protein

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women 50 y or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 11312068BACKGROUND
  • Kerksick 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.

    PMID: 17679046BACKGROUND

MeSH Terms

Conditions

SarcopeniaOsteoporosisInflammation

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Philip D Chilibeck, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 15, 2013

Study Start

December 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations