NCT01931722

Brief 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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

August 26, 2013

Last Update Submit

January 9, 2016

Conditions

Keywords

branched chain amino acid requirementolder menstrength trainingsarcopenia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Muscle size

    12 months

Study Arms (2)

Branched chain amino acid

ACTIVE COMPARATOR

Branched chain amino acid as food supplement

Dietary Supplement: Branched chain amino acidBehavioral: 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.

Dietary Supplement: Branched chain amino acidBehavioral: Strength training

Interventions

Branched chain amino acidDIETARY_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

Also known as: Ajinomoto branched chain amino acids
Branched chain amino acidWeight 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.

Also known as: weight training
Branched chain amino acidWeight training

Eligibility Criteria

Age55 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recreationally active (\~2-3 h/wk of physical activity) healthy older men (55-65 y)
  • A minimum of 4 month weight training experience

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Research Laboratory

London, Ontario, N6A 5B9, Canada

Location

Related Publications (15)

  • 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.

    PMID: 12730426BACKGROUND
  • 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.

    PMID: 1400008BACKGROUND
  • 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.

    PMID: 16424142BACKGROUND
  • 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.

    PMID: 12626690BACKGROUND
  • 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.

    PMID: 12885705BACKGROUND
  • 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.

    PMID: 11023001BACKGROUND
  • 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.

    PMID: 16365106BACKGROUND
  • 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.

    PMID: 19800212BACKGROUND
  • 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.

    PMID: 16507602BACKGROUND
  • 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.

    PMID: 16280440BACKGROUND
  • 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.

    PMID: 17921376BACKGROUND
  • 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.

    PMID: 19079937BACKGROUND
  • 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.

    PMID: 23134885BACKGROUND
  • 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.

    PMID: 9808642BACKGROUND
  • 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.

    PMID: 11382798BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Amino Acids, Branched-ChainResistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and ProteinsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Peter Lemon, PhD

    The University of Western Ontario

    PRINCIPAL INVESTIGATOR
  • Arash Bandegan, MSc.

    The University of Western Ontario

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Weider Research Chair

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations