- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02347137
Influence of Reduced Daily Step Count and Anabolic Interventions on Muscle Protein Metabolism in Older Persons
January 21, 2015 updated by: McMaster University
Efficacy of Isolated Whey and Micellar Whey Protein (+/-Citrulline) to Stimulate Protein Synthesis in 'Healthy' and 'Anabolically Resistant' Elderly Muscle
As the loss of muscle mass with aging is associated with a dysregulation of muscle protein synthesis (MPS) that is generally characterized by an 'anabolic resistance' to nutrients, the primary outcome of the trial is to investigate the effect of a mixed macronutrient beverage on post-prandial myofibrillar MPS.
However, the 'anabolic resistance' of aging may be predominantly influenced by the contractile activity of skeletal muscle; for example, the investigators have demonstrated that 2 weeks of reduced habitual activity (i.e.
daily step count) induces anabolic resistance in otherwise healthy older adults.
In contrast, resistance exercise is well-known to enhance muscle mass and can increase the sensitivity of skeletal muscle to dietary amino acids.
Therefore, all participants will undergo a 2-week reduced step count intervention combined with a unilateral leg resistance exercise protocol to induce an 'unhealthy' or 'anabolically resistant' leg and a relatively 'healthy' or 'anabolically sensitive' leg, respectively; this within subject model will be utilized to investigate the effect of the mixed macronutrient beverage in both relatively 'healthy' and 'unhealthy' older muscle.
The investigators will also measure changes in muscle mass, muscle function, and cardiovascular health of both legs before and after the 2-week intervention to determine the effect of reduced activity and the protective effect of minimal, low-intensity exercise on these outcomes.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Non-smoker
Exclusion Criteria:
- Health problems such as: heart disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put the participant at risk for this study
- Failed clearance for exercise participation by the participants family physician/medical doctor
- Failed an exercise strength test.
- Regular consumption of any analgesic or anti-inflammatory drug(s), prescription or non-prescription, chronically will be excluded.
- Taking any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
- Factors that may exclude a participant from an MRI scan (i.e. various implants, metal in the eyes etc)
- Participants who complete fewer than 5000 steps per day (as assessed by pedometer prior to the study).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Isolated Whey Protein
20 g isolated whey protein + 15 g non-essential amino acids
|
reduce daily physical activity to less than 1500 steps per day
reduce physical activity to less than 1500 steps per day with thrice weekly low-load, high effort resistance exercise
|
Experimental: Micellar Whey Protein
20 g micellar whey protein + 15 g non-essential amino acids
|
reduce daily physical activity to less than 1500 steps per day
reduce physical activity to less than 1500 steps per day with thrice weekly low-load, high effort resistance exercise
|
Experimental: Micellar Whey Protein + Citrulline
20 g micellar whey protein + 5 g citrulline
|
reduce daily physical activity to less than 1500 steps per day
reduce physical activity to less than 1500 steps per day with thrice weekly low-load, high effort resistance exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myofibrillar fractional synthetic rate will be measured using 13C6 ring phenylalanine
Time Frame: 7 hours
|
analysis
|
7 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition (lean body mass, fat mass, leg lean mass, leg fat mass) will be measured using dual energy xray absorptiometry
Time Frame: 14 days
|
analysis
|
14 days
|
leg muscle strength (leg press and leg extension 1 repetition maximum [1-RM], peak knee extensor torque) will be measured using a dynamometer
Time Frame: 14 days
|
analysis
|
14 days
|
vascular function (femoral blood flow, femoral artery diameter, leg pulse) will be measured using doppler ultrasound
Time Frame: 14 days
|
analysis
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
- Burd NA, West DW, Moore DR, Atherton PJ, Staples AW, Prior T, Tang JE, Rennie MJ, Baker SK, Phillips SM. Enhanced amino acid sensitivity of myofibrillar protein synthesis persists for up to 24 h after resistance exercise in young men. J Nutr. 2011 Apr 1;141(4):568-73. doi: 10.3945/jn.110.135038. Epub 2011 Feb 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 6, 2015
First Submitted That Met QC Criteria
January 21, 2015
First Posted (Estimate)
January 27, 2015
Study Record Updates
Last Update Posted (Estimate)
January 27, 2015
Last Update Submitted That Met QC Criteria
January 21, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 11-267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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