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The Effect of Bovine Colostrum Supplementation in Older Adults

Primary Purpose

Sarcopenia, Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Bovine colostrum

Whey protein

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Osteoporosis, Cognition, Inflammation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men or women 50 y or older

Exclusion Criteria:

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

Sites / Locations

College of Kinesiology, University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bovine Colostrum

Whey protein

Arm Description

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)

60 g/d whey protein powder mixed into drinks. It is to be divided into 3 daily doses (20 g per dose)

Outcomes

Primary Outcome Measures

change from baseline in lean tissue mass at 8 weeks

Lean tissue mass assessed by dual energy x-ray absorptiometry

Change from baseline in Upper body strength at 8 weeks

Bench Press Strength

Change from baseline in Lower body strength at 8 weeks

Leg press strength

Secondary Outcome Measures

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

IGF-1 from serum

Change from baseline in upper body muscle thickness at 8 weeks

Muscle thickness of the elbow flexors assessed by ultrasound

Change from baseline in lower body muscle thickness at 8 weeks

Knee extensors muscle thickness assessed by ultrasound

Change from baseline in muscle catabolism at 8 weeks

Urinary 3-methylhistidine levels

Change from baseline in bone catabolism at 8 weeks

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

Adverse events collected on adverse event forms

Change from baseline in inflammation at 8 weeks

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

Change from baseline in cognitive ability at 8 weeks

The Telephone Interview of Cognitive Status

Full Information

NCT ID

NCT01792297

First Posted

February 4, 2013

Last Updated

May 2, 2017

Sponsor

University of Saskatchewan

Collaborators

Mitacs

1. Study Identification

Unique Protocol Identification Number

NCT01792297

Brief Title

The Effect of Bovine Colostrum Supplementation in Older Adults

Official Title

The Effect of Bovine Colostrum Supplementation in Older Adults

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Saskatchewan

Collaborators

Mitacs

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia, Osteoporosis

Keywords

Sarcopenia, Osteoporosis, Cognition, Inflammation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bovine Colostrum

Arm Type

Experimental

Arm Description

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)

Arm Title

Whey protein

Arm Type

Active Comparator

Arm Description

60 g/d whey protein powder mixed into drinks. It is to be divided into 3 daily doses (20 g per dose)

Intervention Type

Dietary Supplement

Intervention Name(s)

Bovine colostrum

Intervention Type

Dietary Supplement

Intervention Name(s)

Whey protein

Primary Outcome Measure Information:

Title

change from baseline in lean tissue mass at 8 weeks

Description

Lean tissue mass assessed by dual energy x-ray absorptiometry

Time Frame

baseline and 8 weeks

Title

Change from baseline in Upper body strength at 8 weeks

Description

Bench Press Strength

Time Frame

baseline and 8 weeks

Title

Change from baseline in Lower body strength at 8 weeks

Description

Leg press strength

Time Frame

baseline and 8 weeks

Secondary Outcome Measure Information:

Title

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

Description

IGF-1 from serum

Time Frame

baseline and 8 weeks

Title

Change from baseline in upper body muscle thickness at 8 weeks

Description

Muscle thickness of the elbow flexors assessed by ultrasound

Time Frame

baseline and 8 weeks

Title

Change from baseline in lower body muscle thickness at 8 weeks

Description

Knee extensors muscle thickness assessed by ultrasound

Time Frame

baseline and 8 weeks

Title

Change from baseline in muscle catabolism at 8 weeks

Description

Urinary 3-methylhistidine levels

Time Frame

baseline and 8 weeks

Title

Change from baseline in bone catabolism at 8 weeks

Description

Urinary cross-linked N-telopeptides of type I collagen

Time Frame

Baseline and 8 weeks

Title

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

Description

Adverse events collected on adverse event forms

Time Frame

continuously throughout 8 weeks

Title

Change from baseline in inflammation at 8 weeks

Description

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

Time Frame

baseline and 8 weeks

Title

Change from baseline in cognitive ability at 8 weeks

Description

The Telephone Interview of Cognitive Status

Time Frame

baseline and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip D Chilibeck, PhD

Organizational Affiliation

University of Saskatchewan

Official's Role

Principal Investigator

Facility Information:

Facility Name

College of Kinesiology, University of Saskatchewan

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 5B2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

11312068

Citation

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.

Results Reference

background

PubMed Identifier

17679046

Citation

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.

Results Reference

background

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The Effect of Bovine Colostrum Supplementation in Older Adults

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