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

This study has been completed.
Sponsor:
Collaborator:
National Dairy Council
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01062711
First received: February 3, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention
Sarcopenia
Dietary Supplement: Whey or soy protein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Muscle protein synthesis [ Time Frame: Acute within the day ] [ Designated as safety issue: No ]
  • whole body amino acid oxidation [ Time Frame: acute within the day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle protein breakdown [ Time Frame: Acute within the day ] [ Designated as safety issue: No ]
  • serum insulin [ Time Frame: acute within the day ] [ Designated as safety issue: No ]
  • plasma amino acid concentrations [ Time Frame: acute within the day ] [ Designated as safety issue: No ]

Estimated Enrollment: 81
Study Start Date: July 2008
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control group 0 g protein
Control group in which a placebo drink containing no protein is given following unilateral knee extension exercise
Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins
Experimental: 10g whey
10g whey protein given following unilateral knee extension exercise
Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins
Experimental: 20g whey
20g whey protein given following unilateral knee extension exercise
Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins
Experimental: 30g whey
30g whey protein given following unilateral knee extension exercise
Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins
Experimental: 40g whey
40g whey protein given following unilateral knee extension exercise
Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins
Experimental: 20g soy
20g soy protein given following unilateral knee extension exercise
Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins
Experimental: 40g soy
40g soy protein given following unilateral knee extension exercise
Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062711

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
National Dairy Council
Investigators
Principal Investigator: Stuart Phillips, Ph.D. McMaster University
  More Information

No publications provided

Responsible Party: Stuart Phillips, Ph.D., Professor and Associate Chair, Graduate Studies, McMaster University, Department of Kinesiology
ClinicalTrials.gov Identifier: NCT01062711     History of Changes
Other Study ID Numbers: DMI 1484
Study First Received: February 3, 2010
Last Updated: July 19, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
sarcopenia
muscle
protein
muscle protein synthesis
muscle protein breakdown
whey
soy
casein
dose response
resistance exercise
unilateral
knee extension
whole body protein

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014