Athletic PerformanceVolleyAGPCNCT02886130
Alpha-GPC and Physical and Cognitive Performances in Volleyball Players.
A study testing Experimental in people with Athletic Performance, run by Université de Montréal at 1 site in Canada.
Trial summary
In order to attain the elite level on the national scene, volleyball players need several attributes. In addition to mastering technical and tactical skills, great jumping ability is another important asset. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Experimental
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 29 Aug 2016to 20 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a competitive varsity volleyball player
Who cannot join
- Regular consumption of alpha-GPC within the last 4 months
- Receiving drug treatment except 1) contraception (pill), and 2) treatment against asthma
Trial locations and contacts
1 site in 1 country.
Canada1 site
CEPSUM (Centre d'éducation physique et des sports de l'université de Montréal)
Montreal, Quebec, H3C3J7
About this study
Official title: Effects of Alpha-glycerylphosphorylcholine on Physical and Cognitive Performances in Varsity Volleyball Players
In order to attain the elite level on the national scene, volleyball players need several attributes. In addition to mastering technical and tactical skills, great jumping ability is another important asset. Maximal power output needed to achieve height during a jump necessitates coordinated neuromuscular recruitment and muscle mass among others. Interestingly, there are claims that alpha-glycerylphosphorylcholine (A-GPC) increases acetylcholine synthesis and enhances exercise-induced increases in plasma growth hormone concentrations, two factors that could theoretically be associated neuromuscular transmission and muscle mass.
However, until now only a few studies have investigated the role of A-GPC in human exercise performance. Published results were mixed. One recent study showed that isometric peak force was slightly but significantly increased when subjects had ingested a daily dose of 600 mg of A-GPC over a period of 6 days (Bellar et al., JISSN, 2015).
The objective of our study is to evaluate the longer-term effects (4 weeks) using a higher dose (1000 mg/day) of A-GPC on jumping capabilities in elite male and female volleyball players.
Read the detailed description
Our study design will be a placebo controlled, randomized, double-blind, crossover study. Varsity male and female volleyball players (n=28) will each be asked to participate in both arms of the study, i.e. placebo and A-GPC (1000 mg/kg/day). The duration of each arm of the study will be 4 weeks separated by a 7-day washout period. The order of treatment (placebo or A-GPC) will be determined randomly. Athletes will be asked to maintain their training load during the duration of the experiment.
- Conditions
- Athletic Performance
- Being tested
- Placebo, Experimental
- Keywords
- Alpha-GPC, Volleyball, Athletes, Executive functions, Vertical jump, Peak power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Maltodextrin, Control
Monitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study.
ExperimentalDietary supplement
Also called Alpha-gpc, Alpha-glycerylphosphorylcholine, Alpha-gpc supplementation, A-GPC
Monitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin tablets (4x per day) 2 x 250 mg in the morning, 2 x 250 mg 60 min before workout, 4 weeks duration Receives: Dietary Supplement: Placebo |
| Alpha-GPC | Experimental | Alpha-GPC tablets (4x per day) 2 x 250 mg in the morning, 2 x 250 mg 60 min before workout, 4 weeks duration Receives: Dietary Supplement: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in countermovement jump performance at 4 weeks
Jump height is calculated using two forces plates which measures the time the feet are off the platform. The athlete stands upright with weight evenly distributed over both feet. Hands are placed on the hips, and stay there throughout the test. When all is ready, the athlete squats down until the knees are bent at 90 degrees, then immediately jumps vertically as high as possible, landing back on the platform on both feet at the same time. Allow a good rest between trials. The take-off must be from both feet, with no initial steps or shuffling. They must also not pause at the base of the squat.
Measured: Assessments at week 0 and at week 4 of supplementation or placebo
Secondary outcomes (2)
Change in vertical jump - run up at 4 weeks
Record the standing height of the subject by getting then to stand directly below the apparatus with both feet on tip-toes, and then stretch up one arm and reach as high as possible. The subject then stands the appropriate distance from the base of the apparatus (about 15 feet), and when ready take 3 or so steps before leaping off up off both legs as high as possible, using the arms to assist in projecting the body upwards. The subject should aim to take off just short of the apparatus, so that at the peak of the jump they are directly under it.
Measured: Assessments at week 0 and at week 4 of supplementation or placebo
Executive function
"Task switching" is a useful tool to investigate executive functions in humans. This task allows investigation of the ability to maintain, select and switch among task sets.
Measured: After 4 weeks of supplementation or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start29 Aug 2016
- Primary completion20 Dec 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Athletic PerformanceStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raynald Bergeron, Université de Montréal
- Investigators
- Samuel St-Arnaud, B.Sc, Principal investigator, Université de MontréalRaynald Bergeron, Ph.D, Study director, Université de MontréalJonathan Tremblay, Ph.D, Study director, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886130
- Sponsor's protocol ID
- Montreal
- Acronym
- VolleyAGPC
- Status last verified
- Apr 2017
- First submitted
- 24 Aug 2016
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual data obtained from vertical jump assessments and during the cognitive switch task will be communicated to each athlete.
Publications
Bellar D, LeBlanc NR, Campbell B. The effect of 6 days of alpha glycerylphosphorylcholine on isometric strength. J Int Soc Sports Nutr. 2015 Nov 17;12:42. doi: 10.1186/s12970-015-0103-x. eCollection 2015.
PubMed 26582972Barbagallo Sangiorgi G, Barbagallo M, Giordano M, Meli M, Panzarasa R. alpha-Glycerophosphocholine in the mental recovery of cerebral ischemic attacks. An Italian multicenter clinical trial. Ann N Y Acad Sci. 1994 Jun 30;717:253-69. doi: 10.1111/j.1749-6632.1994.tb12095.x.
PubMed 8030842Hoffman JR, Ratamess NA, Gonzalez A, Beller NA, Hoffman MW, Olson M, Purpura M, Jager R. The effects of acute and prolonged CRAM supplementation on reaction time and subjective measures of focus and alertness in healthy college students. J Int Soc Sports Nutr. 2010 Dec 15;7:39. doi: 10.1186/1550-2783-7-39.
PubMed 21156078Kidd PM. Integrated brain restoration after ischemic stroke--medical management, risk factors, nutrients, and other interventions for managing inflammation and enhancing brain plasticity. Altern Med Rev. 2009 Mar;14(1):14-35.
PubMed 19364191Parnetti L, Amenta F, Gallai V. Choline alphoscerate in cognitive decline and in acute cerebrovascular disease: an analysis of published clinical data. Mech Ageing Dev. 2001 Nov;122(16):2041-55. doi: 10.1016/s0047-6374(01)00312-8.
PubMed 11589921Traini E, Bramanti V, Amenta F. Choline alphoscerate (alpha-glyceryl-phosphoryl-choline) an old choline- containing phospholipid with a still interesting profile as cognition enhancing agent. Curr Alzheimer Res. 2013 Dec;10(10):1070-9. doi: 10.2174/15672050113106660173.
PubMed 24156263Zeisel SH. A brief history of choline. Ann Nutr Metab. 2012;61(3):254-8. doi: 10.1159/000343120. Epub 2012 Nov 26.
PubMed 23183298Gajewski PD, Wild-Wall N, Schapkin SA, Erdmann U, Freude G, Falkenstein M. Effects of aging and job demands on cognitive flexibility assessed by task switching. Biol Psychol. 2010 Oct;85(2):187-99. doi: 10.1016/j.biopsycho.2010.06.009. Epub 2010 Jul 3.
PubMed 20599468
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alpha-glycerylphosphorylcholine on Physical and Cognitive Performances in Varsity Volleyball Players
- ClinicalTrials.gov ID
- NCT02886130
- Acronym / sponsor ID
- VolleyAGPC / Montreal
- Conditions
- Athletic Performance
- Keywords
- Alpha-GPC, Volleyball, Athletes, Executive functions, Vertical jump, Peak power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 1 Sep 2016 (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.
In order to attain the elite level on the national scene, volleyball players need several attributes. In addition to mastering technical and tactical skills, great jumping ability is another important asset. Maximal power output needed to achieve height during a jump necessitates coordinated neuromuscular recruitment and muscle mass among others. Interestingly, there are claims that alpha-glycerylphosphorylcholine (A-GPC) increases acetylcholine synthesis and enhances exercise-induced increases in plasma growth hormone concentrations, two factors that could theoretically be associated neuromuscular transmission and muscle mass.
However, until now only a few studies have investigated the role of A-GPC in human exercise performance. Published results were mixed. One recent study showed that isometric peak force was slightly but significantly increased when subjects had ingested a daily dose of 600 mg of A-GPC over a period of 6 days (Bellar et al., JISSN, 2015).
The objective of our study is to evaluate the longer-term effects (4 weeks) using a higher dose (1000 mg/day) of A-GPC on jumping capabilities in elite male and female volleyball players.
Detailed description
Our study design will be a placebo controlled, randomized, double-blind, crossover study. Varsity male and female volleyball players (n=28) will each be asked to participate in both arms of the study, i.e. placebo and A-GPC (1000 mg/kg/day). The duration of each arm of the study will be 4 weeks separated by a 7-day washout period. The order of treatment (placebo or A-GPC) will be determined randomly. Athletes will be asked to maintain their training load during the duration of the experiment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin tablets (4x per day) 2 x 250 mg in the morning, 2 x 250 mg 60 min before workout, 4 weeks duration |
| Alpha-GPC | Experimental | Dietary Supplement: ExperimentalAlpha-GPC tablets (4x per day) 2 x 250 mg in the morning, 2 x 250 mg 60 min before workout, 4 weeks duration |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Be a competitive varsity volleyball player
Key exclusion criteria (2 listed)
- Regular consumption of alpha-GPC within the last 4 months
- Receiving drug treatment except 1) contraception (pill), and 2) treatment against asthma
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 |
|---|---|---|
| PlaceboAlso: Maltodextrin, ControlMonitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study. | Dietary supplement | Placebo |
| ExperimentalAlso: Alpha-gpc, Alpha-glycerylphosphorylcholine, Alpha-gpc supplementation, A-GPCMonitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study. | Dietary supplement | Alpha-GPC |
Primary outcome
Change in countermovement jump performance at 4 weeks
Time frame: Assessments at week 0 and at week 4 of supplementation or placebo
Jump height is calculated using two forces plates which measures the time the feet are off the platform. The athlete stands upright with weight evenly distributed over both feet. Hands are placed on the hips, and stay there throughout the test. When all is ready, the athlete squats down until the knees are bent at 90 degrees, then immediately jumps vertically as high as possible, landing back on the platform on both feet at the same time. Allow a good rest between trials. The take-off must be from both feet, with no initial steps or shuffling. They must also not pause at the base of the squat.
2 secondary outcomes
Change in vertical jump - run up at 4 weeks
Time frame: Assessments at week 0 and at week 4 of supplementation or placebo
Executive function
Time frame: After 4 weeks of supplementation or placebo
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 21 Apr 2017.
- Background: PubMed 26582972Bellar D, LeBlanc NR, Campbell B. The effect of 6 days of alpha glycerylphosphorylcholine on isometric strength. J Int Soc Sports Nutr. 2015 Nov 17;12:42. doi: 10.1186/s12970-015-0103-x. eCollection 2015.
- Background: PubMed 8030842Barbagallo Sangiorgi G, Barbagallo M, Giordano M, Meli M, Panzarasa R. alpha-Glycerophosphocholine in the mental recovery of cerebral ischemic attacks. An Italian multicenter clinical trial. Ann N Y Acad Sci. 1994 Jun 30;717:253-69. doi: 10.1111/j.1749-6632.1994.tb12095.x.
- Background: PubMed 21156078Hoffman JR, Ratamess NA, Gonzalez A, Beller NA, Hoffman MW, Olson M, Purpura M, Jager R. The effects of acute and prolonged CRAM supplementation on reaction time and subjective measures of focus and alertness in healthy college students. J Int Soc Sports Nutr. 2010 Dec 15;7:39. doi: 10.1186/1550-2783-7-39.
- Background: PubMed 19364191Kidd PM. Integrated brain restoration after ischemic stroke--medical management, risk factors, nutrients, and other interventions for managing inflammation and enhancing brain plasticity. Altern Med Rev. 2009 Mar;14(1):14-35.
- Background: PubMed 11589921Parnetti L, Amenta F, Gallai V. Choline alphoscerate in cognitive decline and in acute cerebrovascular disease: an analysis of published clinical data. Mech Ageing Dev. 2001 Nov;122(16):2041-55. doi: 10.1016/s0047-6374(01)00312-8.
- Background: PubMed 24156263Traini E, Bramanti V, Amenta F. Choline alphoscerate (alpha-glyceryl-phosphoryl-choline) an old choline- containing phospholipid with a still interesting profile as cognition enhancing agent. Curr Alzheimer Res. 2013 Dec;10(10):1070-9. doi: 10.2174/15672050113106660173.
- Background: PubMed 23183298Zeisel SH. A brief history of choline. Ann Nutr Metab. 2012;61(3):254-8. doi: 10.1159/000343120. Epub 2012 Nov 26.
- Background: PubMed 20599468Gajewski PD, Wild-Wall N, Schapkin SA, Erdmann U, Freude G, Falkenstein M. Effects of aging and job demands on cognitive flexibility assessed by task switching. Biol Psychol. 2010 Oct;85(2):187-99. doi: 10.1016/j.biopsycho.2010.06.009. Epub 2010 Jul 3.
- The effects of alpha-glycerylphosphorylcholine, caffeine or placebo on markers of mood, cognitive function, power, speed, and agilityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual data obtained from vertical jump assessments and during the cognitive switch task will be communicated to each athlete.
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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.
Samuel St-Arnaud, B.Sc principal investigator
Université de Montréal
Raynald Bergeron, Ph.D study director
Université de Montréal
Jonathan Tremblay, Ph.D study director
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Athletic Performance, run by Université de Montréal 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 1 inclusion and 2 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 21 Apr 2017. 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.
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?
Change in countermovement jump performance at 4 weeks (time frame: Assessments at week 0 and at week 4 of supplementation or placebo). 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 NCT02886130, which also lists 8 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 21 Apr 2017.