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Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men (NDC)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Whey or soy protein
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring sarcopenia, muscle, protein, muscle protein synthesis, muscle protein breakdown, whey, soy, casein, dose response, resistance exercise, unilateral, knee extension, whole body protein

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male
  • Aged 60 to 80 years old
  • Non-smoker
  • Generally healthy and can tolerate the resistance exercise and protein drink

Exclusion Criteria:

  • Allergies to whey, casein or soy
  • Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
  • Failed clearance for exercise participation by their medical doctor
  • Failed an exercise stress test
  • Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
  • Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
  • Taking medications for lung and kidney conditions but excluding medication for asthma that is under control

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control group 0 g protein

10g whey

20g whey

30g whey

40g whey

20g soy

40g soy

Arm Description

Control group in which a placebo drink containing no protein is given following unilateral knee extension exercise

10g whey protein given following unilateral knee extension exercise

20g whey protein given following unilateral knee extension exercise

30g whey protein given following unilateral knee extension exercise

40g whey protein given following unilateral knee extension exercise

20g soy protein given following unilateral knee extension exercise

40g soy protein given following unilateral knee extension exercise

Outcomes

Primary Outcome Measures

Muscle protein synthesis
whole body amino acid oxidation

Secondary Outcome Measures

muscle protein breakdown
serum insulin
plasma amino acid concentrations

Full Information

First Posted
February 3, 2010
Last Updated
July 19, 2011
Sponsor
McMaster University
Collaborators
National Dairy Council
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1. Study Identification

Unique Protocol Identification Number
NCT01062711
Brief Title
Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men
Acronym
NDC
Official Title
Responses of Muscle and Whole-body Protein Turnover to Ingestion of Differing Doses of Whey and Soy Protein With and Without Resistance Exercise in Elderly Men
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McMaster University
Collaborators
National Dairy Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. performing resistance exercise) and proper nutrition, in particular eating enough high quality protein, can help slow the loss of muscle mass or potentially even reverse it. Protein and resistance exercise are thought to do this by stimulating your muscle to make more proteins and/or potentially by slowing down the rate at which your body breaks proteins down. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. However, to date, the effect that whey protein has on muscle protein synthesis, particularly in the elderly has yet to be determined. Thus the purposes of this study are: 1) to determine if whey is an effective source of protein that will stimulate muscle protein synthesis in the elderly, similar to what we have previously seen in young persons; 2) to determine the smallest amount of whey protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if performing resistance exercise will augment the increase in new muscle protein synthesis with whey consumption; and 4) to try and found out if whey is more effective than soy protein in stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the elderly, similar to what we have previously seen in young persons

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, muscle, protein, muscle protein synthesis, muscle protein breakdown, whey, soy, casein, dose response, resistance exercise, unilateral, knee extension, whole body protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group 0 g protein
Arm Type
Other
Arm Description
Control group in which a placebo drink containing no protein is given following unilateral knee extension exercise
Arm Title
10g whey
Arm Type
Experimental
Arm Description
10g whey protein given following unilateral knee extension exercise
Arm Title
20g whey
Arm Type
Experimental
Arm Description
20g whey protein given following unilateral knee extension exercise
Arm Title
30g whey
Arm Type
Experimental
Arm Description
30g whey protein given following unilateral knee extension exercise
Arm Title
40g whey
Arm Type
Experimental
Arm Description
40g whey protein given following unilateral knee extension exercise
Arm Title
20g soy
Arm Type
Experimental
Arm Description
20g soy protein given following unilateral knee extension exercise
Arm Title
40g soy
Arm Type
Experimental
Arm Description
40g soy protein given following unilateral knee extension exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey or soy protein
Intervention Description
Whey and casein are isolated milk proteins
Primary Outcome Measure Information:
Title
Muscle protein synthesis
Time Frame
Acute within the day
Title
whole body amino acid oxidation
Time Frame
acute within the day
Secondary Outcome Measure Information:
Title
muscle protein breakdown
Time Frame
Acute within the day
Title
serum insulin
Time Frame
acute within the day
Title
plasma amino acid concentrations
Time Frame
acute within the day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male Aged 60 to 80 years old Non-smoker Generally healthy and can tolerate the resistance exercise and protein drink Exclusion Criteria: Allergies to whey, casein or soy Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study Failed clearance for exercise participation by their medical doctor Failed an exercise stress test Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin Taking medications for lung and kidney conditions but excluding medication for asthma that is under control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Phillips, Ph.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

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Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men

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