Psychological Phenomena: Central FatiguePhase 1NCT01215396
Impact of Varying Doses of Amino Acids on Exercise, Muscular and Mental Performance
A Phase 1 study testing AminoVital Amino Acid formulation and Amino Vital Amino Acid formulation in people with Psychological Phenomena: Central Fatigue, run by McMaster University at 1 site in Canada.
Trial summary
A number of studies have shown that ingestion of crystalline amino acids, in particular branched chain amino acids (BCAA) can affect endurance performance, markers of muscle damage, and possibly mental focus. It seems that the longer and lower intensity events are affected more by consumption of BCAA. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Phenomena: Central Fatigue
- What is being tested?
- AminoVital Amino Acid formulation and Amino Vital Amino Acid formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Oct 2010
- Phase
- Phase 1
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 18 to 30 years old
- Non-obese (body mass index ≤ 30 kg/m2)
- Non-smoker
- Healthy (see exclusion criteria below)
Who cannot join
- Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through medical history screening questionnaire.
- Arthritic conditions
- Individuals who cannot refrain from consuming any alcoholic beverages during the study
- Individuals who chronically consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription
- A history of neuromuscular problems
- Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
Trial locations and contacts
1 site in 1 country.
About this study
A number of studies have shown that ingestion of crystalline amino acids, in particular branched chain amino acids (BCAA) can affect endurance performance, markers of muscle damage, and possibly mental focus. It seems that the longer and lower intensity events are affected more by consumption of BCAA. This study will test the hypothesis that BCAA availability limits central fatigue (the feeling of tiredness). While various aspects of performance have been tested no study to date has tested multiple exercise, muscular, and mental performance aspects in a single study. Thus, the overall purpose of this study is to determine whether an amino acid supplement changes the mental and physical response to prolonged exercise versus a placebo (carbohydrate drink).
This nutritional supplement could be useful on two levels. Improved mental focus and endurance performance and decreased central fatigue and muscle soreness could be valuable for enhancing athlete performance. Similarly, decreased central fatigue and muscle soreness may increase the willingness of the general public to exercise which could translate into decreased health risks and increased health benefits.
Read the detailed description
Specific Purpose and Hypotheses
In the current proposal we outline a study that will examine a comprehensive battery of tests to assess the efficacy of Amino Vital's Amino Acid (AA) formulation to improve physical and mental performance after exercise.
We hypothesize:
- Ingestion of the Amino Acid (AA) formula will improve cognitive, motor, and physical performance on the post-exercise tasks in a hierarchical manner: 2AA > AA > placebo
- Blood concentrations of amino acids will be higher in the AA trials in a hierarchical manner: 2AA >AA > placebo
- Markers of muscle damage will be lower than placebo in a hierarchical manner: placebo > AA > 2AA
Recruitment Methods and Process Recruitment methods will be passive. Participants will be made aware of the study through the use of Hamilton Health Science/Faculty of Health Sciences Research Ethics Board (HHS/FHS REB) approved posted flyers at McMaster University and will voluntarily initiate contact with the study team. A recruitment poster will also be submitted for posting on the McMaster Daily News webpage.
Research Design and Methodology This study will use a double-blind repeated measures study design in which subjects will complete 7 sessions. The sessions consist of familiarization and the completion of three trials (placebo, AA, 2AA of AminoVital's formulation). Trials will be completed in a randomized, counterbalanced and blocked fashion such that with 12 subjects, 2 participants complete each trial order: ABC, ACB, BCA, BAC, CAB, CBA.
In the first session, participants will be screened using a standard health questionnaire. Interested participants will sign a consent form. They will then undergo testing of maximal oxygen consumption (VO2peak) using a treadmill. Subjects will also familiarize themselves with the physical and mental performance tests: Stroop test, profile of mood states (POMS), isometric strength test and an isokinetic muscle fatigue test. Following this initial session, participants will complete 3 trials (placebo, AA or 2AA drink formula) in random order.
On the first day of a trial, participants will arrive at the lab in the morning after a day of dietary control and a standardized breakfast including the treatment beverage. Prior to beginning exercise, participants will complete the physical and mental performance tests. A small catheter (flexible plastic tube) will be inserted into a forearm vein by Dr. Phillips or a medically trained and qualified member of the laboratory group; Dr. Tarnopolsky is responsible for the individuals inserting the venous catheters. The needle will be removed promptly after the insertion of each catheter; only the catheters will remain in their arms until the end of the trial. The catheter will be used for repeated blood sampling over the next six hours (see Figure 1). Additionally, breath samples will be taken at the same time as the blood samples. Following the performance tests, and prior to the start of exercise, a baseline blood sample will be drawn. Participants will then perform a bout of endurance exercise that consists of treadmill walking for 180 minutes at 40% of their peak VO2. Following the start of exercise, participants will consume a treatment beverage (or placebo) every 20 minutes after the start of exercise and continuing until 20 minutes after exercise (see Figure 1). Following the exercise bout, participants will repeat the physical and mental performance tests.
On the second day of a trial, participants will arrive after having consumed a standard breakfast including the treatment beverage. They will complete the physical and mental performance tests and one blood sample (4 mL) will be taken.
The trial day breakfast will consist of energy estimated for each subject based on the Harris-Benedict equation with an activity factor of 30%. The diet will be 55:30:15 in terms of percent energy from carbohydrate:fat:protein. Subjects will consume the same diet on the days prior to each exercise trial to control for pre-study calorie and carbohydrate/fat intake, which could affect substrate oxidation. Subjects will refrain from consumption of alcohol and caffeine on the day of the trial. Trials will take place at least 5d (but no more than 10d) apart and will commence at a time between ~6-10am and will proceed according to the schematic timeline shown in figure 1. The testing time for subjects will remain consistent throughout the study. We also believe that it is prudent for subjects to consume a fixed and constant volume of water (500 ml with breakfast) during all trials to prevent dehydration and to allow subjects to complete the exercise in safe manner.
Data Analyses/Statistics All data will be analyzed using a repeated measures two-way analysis of variance with time as a within factor and dose as a between factor. Significant ANOVA effects will be further scrutinized using Tukey's test as a post-hoc procedure. Where significant correlation of one variable with another exists, an analysis of covariance may also be performed. Significance will be accepted at P<0.05.
Instrumentation Sample analysis will be carried out using a microplate reader/ELISA for creatine kinase (CK), C-reactive protein (CRP), lactate dehydrogenase (LDH) and myoglobin, glucose and lactate auto-analyzers, High Performance Liquid Chromatography (HPLC) for amino acids as well as a metabolic cart gas analyzer to analyze breath samples.
- Conditions
- Psychological Phenomena: Central Fatigue
- Being tested
- AminoVital Amino Acid formulation, Amino Vital Amino Acid formulation
- Keywords
- Branched Chain Amino Acids, Mental Performance, Muscular Performance, Central Fatigue Theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminoVital Amino Acid formulationDietary supplement
Contains minerals, vitamin C, flavour and sweetener.
Amino Vital Amino Acid formulationDietary supplement
Contains minerals, vitamin C, flavour and sweetener and an amino acid mixture (2.4g of AA as: leucine, isoleucine, valine, arginine and glutamine).
Amino Vital Amino Acid formulationDietary supplement
Contains minerals, vitamin C, flavour and sweetener and a double dose of the amino acid mixture (4.8 g of AA as: leucine, isoleucine, valine, arginine and glutamine).
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Placebo | Placebo comparator | Not described Receives: Dietary Supplement: AminoVital Amino Acid formulation |
| Single Dose | Active comparator | The Amino Vital Focus Zone is a dietary supplement of amino acid mixture, which also contains some minerals, vitamin C, flavour, and sweetener, and its appearance is clear to slightly opaque powder. The Amino Vital Focus Zone contains the five kind of amino acid (L-Leucine, L-Isoleucine, L-Valine, L-Arginine, and L-Glutamine), Citric acid, Vitamin C, some mineral, and sweetener.
Powdered treatments will be dissolved in water and administered orally. This treatment will contain 0.96 g of amino acids. Receives: Dietary Supplement: Amino Vital Amino Acid formulation |
| Double Dose | Active comparator | The Amino Vital Focus Zone is a dietary supplement of amino acid mixture, which also contains some minerals, vitamin C, flavour, and sweetener, and its appearance is clear to slightly opaque powder. The Amino Vital Focus Zone contains the five kind of amino acid (L-Leucine, L-Isoleucine, L-Valine, L-Arginine, and L-Glutamine), Citric acid, Vitamin C, some mineral, and sweetener.
Powdered treatments will be dissolved in water and administered orally. This treatment will contain 1.92 g of amino acids. Receives: Dietary Supplement: Amino Vital Amino Acid formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric strength test
Measured on a Biodex leg extension machine. Subjects performed a 5 second voluntary maximal isometric contraction and peak torque was measured.
Measured: Two Months
Stroop Test
The Stroop test is a neuropsychological test to discern the subject's reaction time and cognitive processing speed. Subjects completed four subtasks in this test consisting of vocalizing the colour of boxes; random words; congruent word and colour; and incongruent word and colour.
Measured: Two months
Wing-Kristofferson Two-Model Test
Subjects will tap their index finger to the beat of a metronome for 10 seconds (synchronization). The metronome will be stopped and the subject will continue tapping for 20 seconds (continuation).
Measured: Two months
Muscle Damage Markers
Measurement of serum concentrations of creatine kinase (CK), lactate dehydrogenase (LDH), myoglobin, C-reactive protein (CRP).
Measured: Two months
Secondary outcomes (3)
Blood Glucose and Lactate
Blood glucose was measured by glucose meter from a blood plasma sample. Blood lactate was measured from blood samples aliquoted into perchloric acid. The same is then neutralized and an assay kit is used to measure the lactate concentration.
Measured: Two months
Plasma amino acid concentrations
Using high-performance liquid chromatography, branched chain amino acid concentrations were measured from plasma samples.
Measured: Two months
Rating of Perceived Exertion
Using the Borg Scale, subjects were asked to rate their perceived exertion or how hard they felt they were working on a scale from 6 to 20.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Psychological Phenomena: Central FatigueStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Investigators
- Stuart M Phillips, Ph.D, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215396
- Sponsor's protocol ID
- REB 09-584
- Status last verified
- Jun 2010
- First submitted
- 5 Oct 2010
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morgan RM, Parry AM, Arida RM, Matthews PM, Davies B, Castell LM. Effects of elevated plasma tryptophan on brain activation associated with the Stroop task. Psychopharmacology (Berl). 2007 Feb;190(3):383-9. doi: 10.1007/s00213-006-0609-7. Epub 2006 Dec 19.
PubMed 17180619Blomstrand E. A role for branched-chain amino acids in reducing central fatigue. J Nutr. 2006 Feb;136(2):544S-547S. doi: 10.1093/jn/136.2.544S.
PubMed 16424144Newsholme EA, Blomstrand E. Branched-chain amino acids and central fatigue. J Nutr. 2006 Jan;136(1 Suppl):274S-6S. doi: 10.1093/jn/136.1.274S.
PubMed 16365097Blomstrand E. Amino acids and central fatigue. Amino Acids. 2001;20(1):25-34. doi: 10.1007/s007260170063.
PubMed 11310928Hassmen P, Blomstrand E, Ekblom B, Newsholme EA. Branched-chain amino acid supplementation during 30-km competitive run: mood and cognitive performance. Nutrition. 1994 Sep-Oct;10(5):405-10.
PubMed 7819652Ohtani M, Maruyama K, Sugita M, Kobayashi K. Amino acid supplementation affects hematological and biochemical parameters in elite rugby players. Biosci Biotechnol Biochem. 2001 Sep;65(9):1970-6. doi: 10.1271/bbb.65.1970.
PubMed 11676007Negro M, Giardina S, Marzani B, Marzatico F. Branched-chain amino acid supplementation does not enhance athletic performance but affects muscle recovery and the immune system. J Sports Med Phys Fitness. 2008 Sep;48(3):347-51.
PubMed 18974721Shimomura Y, Yamamoto Y, Bajotto G, Sato J, Murakami T, Shimomura N, Kobayashi H, Mawatari K. Nutraceutical effects of branched-chain amino acids on skeletal muscle. J Nutr. 2006 Feb;136(2):529S-532S. doi: 10.1093/jn/136.2.529S.
PubMed 16424141Jeukendrup AE, Wallis GA. Measurement of substrate oxidation during exercise by means of gas exchange measurements. Int J Sports Med. 2005 Feb;26 Suppl 1:S28-37. doi: 10.1055/s-2004-830512.
PubMed 15702454Phillips SM, Green HJ, Tarnopolsky MA, Grant SM. Decreased glucose turnover after short-term training is unaccompanied by changes in muscle oxidative potential. Am J Physiol. 1995 Aug;269(2 Pt 1):E222-30. doi: 10.1152/ajpendo.1995.269.2.E222.
PubMed 7653539Phillips SM, Green HJ, Tarnopolsky MA, Grant SM. Increased clearance of lactate after short-term training in men. J Appl Physiol (1985). 1995 Dec;79(6):1862-9. doi: 10.1152/jappl.1995.79.6.1862.
PubMed 8847245Phillips SM, Green HJ, Tarnopolsky MA, Heigenhauser GJ, Grant SM. Progressive effect of endurance training on metabolic adaptations in working skeletal muscle. Am J Physiol. 1996 Feb;270(2 Pt 1):E265-72. doi: 10.1152/ajpendo.1996.270.2.E265.
PubMed 8779948Wilkinson SB, Tarnopolsky MA, Macdonald MJ, Macdonald JR, Armstrong D, Phillips SM. Consumption of fluid skim milk promotes greater muscle protein accretion after resistance exercise than does consumption of an isonitrogenous and isoenergetic soy-protein beverage. Am J Clin Nutr. 2007 Apr;85(4):1031-40. doi: 10.1093/ajcn/85.4.1031.
PubMed 17413102Nosaka K, Sacco P, Mawatari K. Effects of amino acid supplementation on muscle soreness and damage. Int J Sport Nutr Exerc Metab. 2006 Dec;16(6):620-35. doi: 10.1123/ijsnem.16.6.620.
PubMed 17342883Mittleman KD, Ricci MR, Bailey SP. Branched-chain amino acids prolong exercise during heat stress in men and women. Med Sci Sports Exerc. 1998 Jan;30(1):83-91. doi: 10.1097/00005768-199801000-00012.
PubMed 9475648
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Varying Doses of Amino Acids on Exercise, Muscular and Mental Performance
- ClinicalTrials.gov ID
- NCT01215396
- Acronym / sponsor ID
- REB 09-584
- Conditions
- Psychological Phenomena: Central Fatigue
- Keywords
- Branched Chain Amino Acids, Mental Performance, Muscular Performance, Central Fatigue Theory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Oct 2010 (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.
A number of studies have shown that ingestion of crystalline amino acids, in particular branched chain amino acids (BCAA) can affect endurance performance, markers of muscle damage, and possibly mental focus. It seems that the longer and lower intensity events are affected more by consumption of BCAA. This study will test the hypothesis that BCAA availability limits central fatigue (the feeling of tiredness). While various aspects of performance have been tested no study to date has tested multiple exercise, muscular, and mental performance aspects in a single study. Thus, the overall purpose of this study is to determine whether an amino acid supplement changes the mental and physical response to prolonged exercise versus a placebo (carbohydrate drink).
This nutritional supplement could be useful on two levels. Improved mental focus and endurance performance and decreased central fatigue and muscle soreness could be valuable for enhancing athlete performance. Similarly, decreased central fatigue and muscle soreness may increase the willingness of the general public to exercise which could translate into decreased health risks and increased health benefits.
Detailed description
Specific Purpose and Hypotheses
In the current proposal we outline a study that will examine a comprehensive battery of tests to assess the efficacy of Amino Vital's Amino Acid (AA) formulation to improve physical and mental performance after exercise.
We hypothesize:
- Ingestion of the Amino Acid (AA) formula will improve cognitive, motor, and physical performance on the post-exercise tasks in a hierarchical manner: 2AA > AA > placebo
- Blood concentrations of amino acids will be higher in the AA trials in a hierarchical manner: 2AA >AA > placebo
- Markers of muscle damage will be lower than placebo in a hierarchical manner: placebo > AA > 2AA
Recruitment Methods and Process Recruitment methods will be passive. Participants will be made aware of the study through the use of Hamilton Health Science/Faculty of Health Sciences Research Ethics Board (HHS/FHS REB) approved posted flyers at McMaster University and will voluntarily initiate contact with the study team. A recruitment poster will also be submitted for posting on the McMaster Daily News webpage.
Research Design and Methodology This study will use a double-blind repeated measures study design in which subjects will complete 7 sessions. The sessions consist of familiarization and the completion of three trials (placebo, AA, 2AA of AminoVital's formulation). Trials will be completed in a randomized, counterbalanced and blocked fashion such that with 12 subjects, 2 participants complete each trial order: ABC, ACB, BCA, BAC, CAB, CBA.
In the first session, participants will be screened using a standard health questionnaire. Interested participants will sign a consent form. They will then undergo testing of maximal oxygen consumption (VO2peak) using a treadmill. Subjects will also familiarize themselves with the physical and mental performance tests: Stroop test, profile of mood states (POMS), isometric strength test and an isokinetic muscle fatigue test. Following this initial session, participants will complete 3 trials (placebo, AA or 2AA drink formula) in random order.
On the first day of a trial, participants will arrive at the lab in the morning after a day of dietary control and a standardized breakfast including the treatment beverage. Prior to beginning exercise, participants will complete the physical and mental performance tests. A small catheter (flexible plastic tube) will be inserted into a forearm vein by Dr. Phillips or a medically trained and qualified member of the laboratory group; Dr. Tarnopolsky is responsible for the individuals inserting the venous catheters. The needle will be removed promptly after the insertion of each catheter; only the catheters will remain in their arms until the end of the trial. The catheter will be used for repeated blood sampling over the next six hours (see Figure 1). Additionally, breath samples will be taken at the same time as the blood samples. Following the performance tests, and prior to the start of exercise, a baseline blood sample will be drawn. Participants will then perform a bout of endurance exercise that consists of treadmill walking for 180 minutes at 40% of their peak VO2. Following the start of exercise, participants will consume a treatment beverage (or placebo) every 20 minutes after the start of exercise and continuing until 20 minutes after exercise (see Figure 1). Following the exercise bout, participants will repeat the physical and mental performance tests.
On the second day of a trial, participants will arrive after having consumed a standard breakfast including the treatment beverage. They will complete the physical and mental performance tests and one blood sample (4 mL) will be taken.
The trial day breakfast will consist of energy estimated for each subject based on the Harris-Benedict equation with an activity factor of 30%. The diet will be 55:30:15 in terms of percent energy from carbohydrate:fat:protein. Subjects will consume the same diet on the days prior to each exercise trial to control for pre-study calorie and carbohydrate/fat intake, which could affect substrate oxidation. Subjects will refrain from consumption of alcohol and caffeine on the day of the trial. Trials will take place at least 5d (but no more than 10d) apart and will commence at a time between ~6-10am and will proceed according to the schematic timeline shown in figure 1. The testing time for subjects will remain consistent throughout the study. We also believe that it is prudent for subjects to consume a fixed and constant volume of water (500 ml with breakfast) during all trials to prevent dehydration and to allow subjects to complete the exercise in safe manner.
Data Analyses/Statistics All data will be analyzed using a repeated measures two-way analysis of variance with time as a within factor and dose as a between factor. Significant ANOVA effects will be further scrutinized using Tukey's test as a post-hoc procedure. Where significant correlation of one variable with another exists, an analysis of covariance may also be performed. Significance will be accepted at P<0.05.
Instrumentation Sample analysis will be carried out using a microplate reader/ELISA for creatine kinase (CK), C-reactive protein (CRP), lactate dehydrogenase (LDH) and myoglobin, glucose and lactate auto-analyzers, High Performance Liquid Chromatography (HPLC) for amino acids as well as a metabolic cart gas analyzer to analyze breath samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Placebo | Placebo comparator | Dietary Supplement: AminoVital Amino Acid formulation |
| Single Dose | Active comparator | Dietary Supplement: Amino Vital Amino Acid formulationThe Amino Vital Focus Zone is a dietary supplement of amino acid mixture, which also contains some minerals, vitamin C, flavour, and sweetener, and its appearance is clear to slightly opaque powder. The Amino Vital Focus Zone contains the five kind of amino acid (L-Leucine, L-Isoleucine, L-Valine, L-Arginine, and L-Glutamine), Citric acid, Vitamin C, some mineral, and sweetener. Powdered treatments will be dissolved in water and administered orally. This treatment will contain 0.96 g of amino acids. |
| Double Dose | Active comparator | Dietary Supplement: Amino Vital Amino Acid formulationThe Amino Vital Focus Zone is a dietary supplement of amino acid mixture, which also contains some minerals, vitamin C, flavour, and sweetener, and its appearance is clear to slightly opaque powder. The Amino Vital Focus Zone contains the five kind of amino acid (L-Leucine, L-Isoleucine, L-Valine, L-Arginine, and L-Glutamine), Citric acid, Vitamin C, some mineral, and sweetener. Powdered treatments will be dissolved in water and administered orally. This treatment will contain 1.92 g of amino acids. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Aged 18 to 30 years old
- Non-obese (body mass index ≤ 30 kg/m2)
- Non-smoker
- Healthy (see exclusion criteria below)
Key exclusion criteria (6 listed)
- Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through medical history screening questionnaire.
- Arthritic conditions
- Individuals who cannot refrain from consuming any alcoholic beverages during the study
- Individuals who chronically consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription
- A history of neuromuscular problems
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 |
|---|---|---|
| AminoVital Amino Acid formulationContains minerals, vitamin C, flavour and sweetener. | Dietary supplement | Carbohydrate Placebo |
| Amino Vital Amino Acid formulationContains minerals, vitamin C, flavour and sweetener and an amino acid mixture (2.4g of AA as: leucine, isoleucine, valine, arginine and glutamine). | Dietary supplement | Single Dose |
| Amino Vital Amino Acid formulationContains minerals, vitamin C, flavour and sweetener and a double dose of the amino acid mixture (4.8 g of AA as: leucine, isoleucine, valine, arginine and glutamine). | Dietary supplement | Double Dose |
Primary outcome
Isometric strength test
Time frame: Two Months
Measured on a Biodex leg extension machine. Subjects performed a 5 second voluntary maximal isometric contraction and peak torque was measured.
Stroop Test
Time frame: Two months
The Stroop test is a neuropsychological test to discern the subject's reaction time and cognitive processing speed. Subjects completed four subtasks in this test consisting of vocalizing the colour of boxes; random words; congruent word and colour; and incongruent word and colour.
Wing-Kristofferson Two-Model Test
Time frame: Two months
Subjects will tap their index finger to the beat of a metronome for 10 seconds (synchronization). The metronome will be stopped and the subject will continue tapping for 20 seconds (continuation).
Muscle Damage Markers
Time frame: Two months
Measurement of serum concentrations of creatine kinase (CK), lactate dehydrogenase (LDH), myoglobin, C-reactive protein (CRP).
3 secondary outcomes
Blood Glucose and Lactate
Time frame: Two months
Plasma amino acid concentrations
Time frame: Two months
Rating of Perceived Exertion
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
- Results publication: PubMed 17180619Morgan RM, Parry AM, Arida RM, Matthews PM, Davies B, Castell LM. Effects of elevated plasma tryptophan on brain activation associated with the Stroop task. Psychopharmacology (Berl). 2007 Feb;190(3):383-9. doi: 10.1007/s00213-006-0609-7. Epub 2006 Dec 19.
- Results publication: PubMed 16424144Blomstrand E. A role for branched-chain amino acids in reducing central fatigue. J Nutr. 2006 Feb;136(2):544S-547S. doi: 10.1093/jn/136.2.544S.
- Results publication: PubMed 16365097Newsholme EA, Blomstrand E. Branched-chain amino acids and central fatigue. J Nutr. 2006 Jan;136(1 Suppl):274S-6S. doi: 10.1093/jn/136.1.274S.
- Results publication: PubMed 11310928Blomstrand E. Amino acids and central fatigue. Amino Acids. 2001;20(1):25-34. doi: 10.1007/s007260170063.
- Results publication: PubMed 7819652Hassmen P, Blomstrand E, Ekblom B, Newsholme EA. Branched-chain amino acid supplementation during 30-km competitive run: mood and cognitive performance. Nutrition. 1994 Sep-Oct;10(5):405-10.
- Results publication: PubMed 11676007Ohtani M, Maruyama K, Sugita M, Kobayashi K. Amino acid supplementation affects hematological and biochemical parameters in elite rugby players. Biosci Biotechnol Biochem. 2001 Sep;65(9):1970-6. doi: 10.1271/bbb.65.1970.
- Results publication: PubMed 18974721Negro M, Giardina S, Marzani B, Marzatico F. Branched-chain amino acid supplementation does not enhance athletic performance but affects muscle recovery and the immune system. J Sports Med Phys Fitness. 2008 Sep;48(3):347-51.
- Results publication: PubMed 16424141Shimomura Y, Yamamoto Y, Bajotto G, Sato J, Murakami T, Shimomura N, Kobayashi H, Mawatari K. Nutraceutical effects of branched-chain amino acids on skeletal muscle. J Nutr. 2006 Feb;136(2):529S-532S. doi: 10.1093/jn/136.2.529S.
- Results publication: PubMed 15702454Jeukendrup AE, Wallis GA. Measurement of substrate oxidation during exercise by means of gas exchange measurements. Int J Sports Med. 2005 Feb;26 Suppl 1:S28-37. doi: 10.1055/s-2004-830512.
- Results publication: PubMed 7653539Phillips SM, Green HJ, Tarnopolsky MA, Grant SM. Decreased glucose turnover after short-term training is unaccompanied by changes in muscle oxidative potential. Am J Physiol. 1995 Aug;269(2 Pt 1):E222-30. doi: 10.1152/ajpendo.1995.269.2.E222.
- Results publication: PubMed 8847245Phillips SM, Green HJ, Tarnopolsky MA, Grant SM. Increased clearance of lactate after short-term training in men. J Appl Physiol (1985). 1995 Dec;79(6):1862-9. doi: 10.1152/jappl.1995.79.6.1862.
- Results publication: PubMed 8779948Phillips SM, Green HJ, Tarnopolsky MA, Heigenhauser GJ, Grant SM. Progressive effect of endurance training on metabolic adaptations in working skeletal muscle. Am J Physiol. 1996 Feb;270(2 Pt 1):E265-72. doi: 10.1152/ajpendo.1996.270.2.E265.
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.
Stuart M Phillips, Ph.D principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AminoVital Amino Acid formulation and Amino Vital Amino Acid formulation in people with Psychological Phenomena: Central Fatigue, run by McMaster University 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 2 Nov 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Isometric strength test (time frame: Two Months). The study lists 4 primary outcomes in all. 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 NCT01215396, which also lists 16 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 2 Nov 2010.