- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01931722
Exercise and Branched Chain Amino Acids (BCAA)Requirements in Older Men
January 9, 2016 updated by: Peter Lemon, University of Western Ontario, Canada
Can Branched Chained Amino Acid Supplementation Combined With Strength-Training Minimize Sarcopenia in Older Men?
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).
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
6
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
-
London, Ontario, Canada, N6A 5B9
- Exercise Nutrition Research Laboratory
-
-
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
55 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Branched chain amino acid
Branched chain amino acid as food supplement
|
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
Other Names:
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.
Other Names:
|
ACTIVE_COMPARATOR: Weight 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 1RM (repetition maximum).
Instruction will be provided for all exercises and professional trainers will oversee all training sessions.
|
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
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Required Branched chain amino acid of older strength trained men
Time Frame: 12 months
|
Branched chain amino acid requirement will be measured in 55-65 years old strength trained men using indicator amino acid oxidation method
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle size
Time Frame: 12 months
|
cross-sectional measure of muscle size will be measured in all participants using standard procedures of magenetic resonance imaging
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter Lemon, PhD, The University of Western Ontario
- Study Director: Arash Bandegan, MSc., The University of Western Ontario
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
- Norton LE, Layman DK. Leucine regulates translation initiation of protein synthesis in skeletal muscle after exercise. J Nutr. 2006 Feb;136(2):533S-537S. doi: 10.1093/jn/136.2.533S.
- 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. doi: 10.1093/ajcn/86.4.995.
- 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. doi: 10.1093/jn/133.5.1383.
- 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. doi: 10.1152/jappl.1992.73.2.767.
- Pencharz PB, Ball RO. Different approaches to define individual amino acid requirements. Annu Rev Nutr. 2003;23:101-16. doi: 10.1146/annurev.nutr.23.011702.073247. Epub 2003 Feb 21.
- 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. doi: 10.1093/ajcn/78.2.250.
- Lemon PW. Beyond the zone: protein needs of active individuals. J Am Coll Nutr. 2000 Oct;19(5 Suppl):513S-521S. doi: 10.1080/07315724.2000.10718974.
- 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. doi: 10.1093/jn/136.1.319S.
- 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.
- 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. doi: 10.1152/ajpendo.00488.2005. Epub 2006 Feb 28.
- 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. doi: 10.1093/ajcn/82.5.1065.
- 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.
- 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.
- 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. doi: 10.1093/jn/128.11.1913.
- 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. doi: 10.1093/gerona/56.6.m373.
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
January 1, 2016
Primary Completion (ANTICIPATED)
December 1, 2016
Study Completion (ANTICIPATED)
December 1, 2016
Study Registration Dates
First Submitted
August 26, 2013
First Submitted That Met QC Criteria
August 26, 2013
First Posted (ESTIMATE)
August 29, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 12, 2016
Last Update Submitted That Met QC Criteria
January 9, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002 (University of CT Health Center)
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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