SarcopeniaNCT01931722
Exercise and Branched Chain Amino Acids (BCAA)Requirements in Older Men
A study testing Branched chain amino acid and Strength training in people with Sarcopenia, run by University of Western Ontario, Canada at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 55 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Branched chain amino acid and Strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recreationally active (~2-3 h/wk of physical activity) healthy older men (55-65 y)
- A minimum of 4 month weight training experience
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Branched chain amino acid, Strength training
- Keywords
- branched chain amino acid requirement, older men, strength training, sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched chain amino acidDietary supplement
Also called Ajinomoto branched chain amino acids
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
Strength trainingBehavioural
Also called 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Branched chain amino acid | Active comparator | Branched chain amino acid as food supplement Receives: Dietary Supplement: Branched chain amino acid; Behavioral: Strength training |
| Weight training | Active comparator | 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. Receives: Dietary Supplement: Branched chain amino acid; Behavioral: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Muscle size
cross-sectional measure of muscle size will be measured in all participants using standard procedures of magenetic resonance imaging
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: not able to find enough participants for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, University of Western Ontario, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, The University of Western OntarioArash Bandegan, MSc., Study director, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931722
- Sponsor's protocol ID
- 002
- Status last verified
- Jan 2016
- First submitted
- 26 Aug 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12730426Lemon 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.
PubMed 1400008Norton 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.
PubMed 16424142Pencharz 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.
PubMed 12626690Volpi 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.
PubMed 12885705Lemon 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.
PubMed 11023001Layman 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.
PubMed 16365106Kim 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.
PubMed 19800212Katsanos 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.
PubMed 16507602Katsanos 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.
PubMed 16280440Humayun 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.
PubMed 17921376Dardevet 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.
PubMed 19079937Cermak 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.
PubMed 23134885Bross 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.
PubMed 9808642Campbell 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.
PubMed 11382798
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Branched Chained Amino Acid Supplementation Combined With Strength-Training Minimize Sarcopenia in Older Men?
- ClinicalTrials.gov ID
- NCT01931722
- Acronym / sponsor ID
- 002
- Conditions
- Sarcopenia
- Keywords
- branched chain amino acid requirement, older men, strength training, sarcopenia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: not able to find enough participants for this study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branched chain amino acid | Active comparator | Dietary Supplement: Branched chain amino acid, Behavioral: Strength trainingBranched chain amino acid as food supplement |
| Weight training | Active comparator | Dietary Supplement: Branched chain amino acid, Behavioral: Strength trainingStrength 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. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recreationally active (~2-3 h/wk of physical activity) healthy older men (55-65 y)
- A minimum of 4 month weight training experience
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branched chain amino acidAlso: Ajinomoto branched chain amino acidsseven 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 | Dietary supplement | Branched chain amino acid, Weight training |
| Strength trainingAlso: weight trainingStrength 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. | Behavioural | Branched chain amino acid, Weight training |
Primary outcome
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
1 secondary outcome
Muscle size
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Background: PubMed 12730426Riazi 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.
- Background: PubMed 1400008Lemon 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.
- Background: PubMed 16424142Norton 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.
- Background: PubMed 12626690Pencharz 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.
- Background: PubMed 12885705Volpi 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.
- Background: PubMed 11023001Lemon 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.
- Background: PubMed 16365106Layman 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.
- Background: PubMed 19800212Kim 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.
- Background: PubMed 16507602Katsanos 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.
- Background: PubMed 16280440Katsanos 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.
- Background: PubMed 17921376Humayun 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.
- Background: PubMed 19079937Dardevet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lemon, PhD principal investigator
The University of Western Ontario
Arash Bandegan, MSc. study director
The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branched chain amino acid and Strength training in people with Sarcopenia, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Required Branched chain amino acid of older strength trained men (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01931722, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.