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Protein Intake and Step Reduction in Older Adults (DRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03285737
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : March 22, 2018
National Dairy Council
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Sarcopenia, the loss in muscle mass with age, is associated with several negative health outcomes including cancer, stroke, cardiovascular disease and diabetes. This loss of muscle mass remains relatively steady following 50 years of age however it can be accelerated with periods of disuse associated with hospitalization, fracture or surgery of the hip or simply influenza. Also associated with periods of disuse, is a lack of energy intake as hospitalizations often result in undernourishment. The consumption of protein has been shown to stimulate muscle growth and therefore the investigators are wondering whether it is able to offset the loss of muscle mass associated with disuse. Therefore, the purpose of the study is to examine the effects of protein consumption combined with mild caloric restriction on changes in muscle mass and function during a period of disuse as well as during a period of recovery .

Condition or disease Intervention/treatment Phase
Aging Muscle Loss Dietary Supplement: Whey Dietary Supplement: Collagen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel group design (with repeated measurements within each group)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: Whey Protein Intake in the Amelioration of Skeletal Muscle Quantity and Function During Inactivity in Older Adults
Actual Study Start Date : March 23, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Whey protein supplement
Supplement will be delivered twice daily (30g per supplement) of whey protein isolate
Dietary Supplement: Whey
Supplement provided twice daily in 30g doses

Active Comparator: Collagen peptide supplement
Supplement will be delivered twice daily (30g per supplement) of hydrolyzed collagen peptides.
Dietary Supplement: Collagen
Supplement provided twice daily in 30g doses

Primary Outcome Measures :
  1. Integrated myofibrillar muscle protein synthesis with use of deuterated water, measured by GCMS [ Time Frame: 5 weeks ]
    Measured with ingestion of deuterated water, looking at enrichments in total body water versus muscle

Secondary Outcome Measures :
  1. Rockport walk test (submaximal VO2 test) [ Time Frame: 5 weeks ]
    Participants will walk around a 200m track at a self selected pace for a total of 1 mile. Submaximla VO2 will be calculated using their age, sex, time to complete the test and heart rate with the use of a heart rate monitor

  2. Marker of systemic inflammation (TNF-a) [ Time Frame: 5 weeks ]
    Will be measured from a fasted serum sample using commercially available kits

  3. Fasted glucose [ Time Frame: 5 weeks ]
    Will be measured from fasted serum sample using commercially available kits

  4. Fasted insulin [ Time Frame: 5 Weeks ]
    Will be measured from fasted plasma samples using commercially available kits

  5. Timed up and go test [ Time Frame: 5 weeks ]
    A clinical measure where participants are asked to rise from a chair, walk 3 metres and then return back to their original position and sit in the chair without using their arms as aids.

  6. 30 second chair stand test [ Time Frame: 5 weeks ]
    Participants are asked to rise and sit in a chair without the use of their arms, as many times as possible in 30 seconds in a controlled fashion

  7. Maximum isometric voluntary strength of the knee extensors [ Time Frame: 5 weeks ]
    Participants will be seated in a biodex dynamometer with knee angle set at 110 degrees. They will be asked to perform an MVC for 5 seconds and will be provided with a 2 minute rest in between each measurement for a total of 3 measurements.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Free of any chronic conditions
  • Non smoker
  • Non diabetic
  • No consumption of medications known to affect protein metabolism
  • No allergies to dairy proteins
  • Moderately active (3500-10,000 steps per day)
  • No use of a walker or assistive walking device

Exclusion Criteria:

  • Cigarette use, diabetic, non active, use of a walker, consumption of drugs known to affect protein metabolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03285737

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Canada, Ontario
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
National Dairy Council
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Principal Investigator: Stuart M Phillips, Ph.D. McMaster University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: McMaster University Identifier: NCT03285737    
Other Study ID Numbers: HIREB 0574
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Protein ingestion
Muscle protein synthesis