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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02347137
Other study ID # 11-267
Secondary ID
Status Completed
Phase N/A
First received January 6, 2015
Last updated January 21, 2015
Start date July 2012
Est. completion date May 2013

Study information

Verified date January 2015
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
step-reduction
reduce daily physical activity to less than 1500 steps per day
step-reduction plus resistance exercise
reduce physical activity to less than 1500 steps per day with thrice weekly low-load, high effort resistance exercise

Locations

Country Name City State
Canada Exercise Metabolism Research Laboratory, McMaster Univeristy Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Myofibrillar fractional synthetic rate will be measured using 13C6 ring phenylalanine analysis 7 hours No
Secondary body composition (lean body mass, fat mass, leg lean mass, leg fat mass) will be measured using dual energy xray absorptiometry analysis 14 days No
Secondary leg muscle strength (leg press and leg extension 1 repetition maximum [1-RM], peak knee extensor torque) will be measured using a dynamometer analysis 14 days No
Secondary vascular function (femoral blood flow, femoral artery diameter, leg pulse) will be measured using doppler ultrasound analysis 14 days No
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