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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01931722
Other study ID # 002
Secondary ID
Status Suspended
Phase N/A
First received August 26, 2013
Last updated January 9, 2016
Start date January 2016
Est. completion date December 2016

Study information

Verified date January 2016
Source University of Western Ontario, Canada
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Likely, branched chain amino acid (BCAA) requirements are increased in older strength-trained (ST) individuals. If so, supplementation in this group will maximize muscle protein synthesis (MPS) and minimize loss of muscle with age (sarcopenia).


Description:

We hypothesize that the dietary requirement for the branched chain amino acids (BCAA) in an older strength-trained (ST) population will be greater than the current recommendation (RDA). If so, a greater intake of BCAA together with ST is necessary if one aims to maximize muscle protein synthesis (MPS). Currently, the BCAA requirement in the ST older population (55-65 y) is unknown. This is critical information especially given the value of ST for overall health.


Recruitment information / eligibility

Status Suspended
Enrollment 6
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 55 Years to 65 Years
Eligibility Inclusion Criteria:

- Recreationally active (~2-3 h/wk of physical activity) healthy older men (55-65 y)

- A minimum of 4 month weight training experience

Exclusion Criteria:

- Have symptoms or take medication for respiratory disease

- Have symptoms or take medication for cardiovascular disease

- Have symptoms or take medication for metabolic disease

- Have symptoms or take mediation for neuromuscular disease

- Use heart rate or blood pressure medications

- Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time

- Have an excessive alcohol intake (more than 2 drinks per day)

- Have any cardiovascular or neuromuscular limitations to exercise

- Are allergic to milk or milk products

- Use anabolic steroids or performance enhancing drugs

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Branched chain amino acid
seven graded intakes of a BCAA (branched chain amino acid) mixture from 50 to 350 mg.kg-1.d-1 will be used to measure BCAA requirement
Behavioral:
Strength training
Strength training will include a split-training program using all major muscle groups of the body on a three day "on", one day "off" protocol. Muscle areas targeted on each training day will be as follows: Day1: chest, shoulder, triceps; Day2: back, biceps; Day3: legs and calfs; Day4: will be a rest day. On Day5: this cycle will begin again. A combination of free weights and machines will be used for each training day. Progressive overload protocol will be applied where the load used by every participant will be adjusted bi-weekly based on their 70% of 1 repetition maximum (maximum weight that can be lifted only one time). Instruction will be provided for all exercises and professional trainers will oversee all training sessions.

Locations

Country Name City State
Canada Exercise Nutrition Research Laboratory London Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (15)

Bross R, Ball RO, Pencharz PB. Development of a minimally invasive protocol for the determination of phenylalanine and lysine kinetics in humans during the fed state. J Nutr. 1998 Nov;128(11):1913-9. — View Citation

Campbell WW, Trappe TA, Wolfe RR, Evans WJ. The recommended dietary allowance for protein may not be adequate for older people to maintain skeletal muscle. J Gerontol A Biol Sci Med Sci. 2001 Jun;56(6):M373-80. — View Citation

Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7. Review. — View Citation

Dardevet D, Rieu I, Fafournoux P, Sornet C, Combaret L, Bruhat A, Mordier S, Mosoni L, Grizard J. Leucine: a key amino acid in ageing-associated sarcopenia? Nutr Res Rev. 2003 Jun;16(1):61-70. doi: 10.1079/NRR200252. — View Citation

Humayun MA, Elango R, Ball RO, Pencharz PB. Reevaluation of the protein requirement in young men with the indicator amino acid oxidation technique. Am J Clin Nutr. 2007 Oct;86(4):995-1002. — View Citation

Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. A high proportion of leucine is required for optimal stimulation of the rate of muscle protein synthesis by essential amino acids in the elderly. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E381-7. Epub 2006 Feb 28. — View Citation

Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. Aging is associated with diminished accretion of muscle proteins after the ingestion of a small bolus of essential amino acids. Am J Clin Nutr. 2005 Nov;82(5):1065-73. — View Citation

Kim JS, Wilson JM, Lee SR. Dietary implications on mechanisms of sarcopenia: roles of protein, amino acids and antioxidants. J Nutr Biochem. 2010 Jan;21(1):1-13. doi: 10.1016/j.jnutbio.2009.06.014. Epub 2009 Oct 1. Review. — View Citation

Layman DK, Walker DA. Potential importance of leucine in treatment of obesity and the metabolic syndrome. J Nutr. 2006 Jan;136(1 Suppl):319S-23S. Review. — View Citation

Lemon PW, Tarnopolsky MA, MacDougall JD, Atkinson SA. Protein requirements and muscle mass/strength changes during intensive training in novice bodybuilders. J Appl Physiol (1985). 1992 Aug;73(2):767-75. — View Citation

Lemon PW. Beyond the zone: protein needs of active individuals. J Am Coll Nutr. 2000 Oct;19(5 Suppl):513S-521S. Review. — View Citation

Norton LE, Layman DK. Leucine regulates translation initiation of protein synthesis in skeletal muscle after exercise. J Nutr. 2006 Feb;136(2):533S-537S. — View Citation

Pencharz PB, Ball RO. Different approaches to define individual amino acid requirements. Annu Rev Nutr. 2003;23:101-16. Epub 2003 Feb 21. Review. — View Citation

Riazi R, Wykes LJ, Ball RO, Pencharz PB. The total branched-chain amino acid requirement in young healthy adult men determined by indicator amino acid oxidation by use of L-[1-13C]phenylalanine. J Nutr. 2003 May;133(5):1383-9. — View Citation

Volpi E, Kobayashi H, Sheffield-Moore M, Mittendorfer B, Wolfe RR. Essential amino acids are primarily responsible for the amino acid stimulation of muscle protein anabolism in healthy elderly adults. Am J Clin Nutr. 2003 Aug;78(2):250-8. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Required Branched chain amino acid of older strength trained men Branched chain amino acid requirement will be measured in 55-65 years old strength trained men using indicator amino acid oxidation method 12 months No
Secondary Muscle size cross-sectional measure of muscle size will be measured in all participants using standard procedures of magenetic resonance imaging 12 months No
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