HealthyCREANCT03352128
Creatine Supplementation and Cognitive and Physical Tests
A study testing Creatine and Calcium lactate in people with Healthy and Creatine Supplementation, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
To assess whether brain creatine availability has an effect on cognition. To do so we will seek to increase brain creatine concentration via a creatine supplementation protocol. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Creatine Supplementation
- What is being tested?
- Creatine and Calcium lactate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Sep 2018to 28 Mar 2019
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (No neurological illness including cardiovascular, renal, and endocrine disorder)
- Male/female
- No medication / supplements
- Non-smoker
- Low to moderately active
- Between 18 and 35 years old
Who cannot join
- Injuries
- Illness
- Use of medication
- Use of creatine in the last 3 months
- History of head trauma or seizure
- Vegetarian diet [24]
- Not being able to follow up the restrictions and prohibitions for the subjects (see Restrictions and prohibitions for the subjects)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Human Physiology and Sports Physiotherapy Research Group
Brussels
About this study
Official title: The Effect of Creatine Supplementation on Cognitive and Physical Tests
To assess whether brain creatine availability has an effect on cognition. To do so we will seek to increase brain creatine concentration via a creatine supplementation protocol.
- Conditions
- Healthy, Creatine Supplementation
- Being tested
- Creatine, Calcium lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Participants will have to supplement themselves with creatine for 7 days (20g/day).
Calcium lactateDietary supplement
Participants will have to supplement themselves with calcium lactate for 7 days (elemental calcium: 0.780g/day).
| Study group | Role | What they receive |
|---|---|---|
| Creatine supplementation | Experimental | 7-day creatine supplementation Receives: Dietary Supplement: Creatine |
| Placebo supplementation | Placebo comparator | 7-day calcium lactate supplementation Receives: Dietary Supplement: Calcium lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance - change in accuracy (%) during a 90-min cognitive task (i.e. Stroop task)
Accuracy (in %) will be assessed during a cognitive task, this cognitive task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)
Measured: During both lab visits (i.e. after both 7-day supplementation protocols); Accuracy (%) will be assessed during both lab visits with a 90-min cognitive task; Accuracy during the 90-min task will be reported as mean accuracy during 8 blocks of 11min15sec
Cognitive performance - change in reaction time (milliseconds) during a 90-min cognitive task (i.e. Stroop task)
Reaction time (in milliseconds) will be assessed during a cognitive task, this cognitive task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)
Measured: During both lab visits (i.e. after both 7-day supplementation protocols); Reaction time (RT) will be assessed during both lab visits with a 90-min cognitive task; RT during the 90-min task will be reported as mean RT during 8 blocks of 11min15sec
Secondary outcomes (1)
Physical performance - reaction time (milliseconds) during a 7-min visuomotor reaction time task
Reaction time (in milliseconds) will be assessed during a visuomotor reaction time task, this physical task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)
Measured: During both lab visits (i.e. after both 7-day supplementation protocols); visuomotor reaction time will be assessed during both lab visits with a 7-min visuomotor reaction time task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start10 Sep 2018
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352128
- Sponsor's protocol ID
- CREA
- Acronym
- CREA
- Status last verified
- Oct 2019
- First submitted
- 8 Nov 2017
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Creatine Supplementation on Cognitive and Physical Tests
- ClinicalTrials.gov ID
- NCT03352128
- Acronym / sponsor ID
- CREA / CREA
- Conditions
- Healthy, Creatine Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 24 Nov 2017 (actual)
- 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.
To assess whether brain creatine availability has an effect on cognition. To do so we will seek to increase brain creatine concentration via a creatine supplementation protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine supplementation | Experimental | Dietary Supplement: Creatine7-day creatine supplementation |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Calcium lactate7-day calcium lactate supplementation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy (No neurological illness including cardiovascular, renal, and endocrine disorder)
- Male/female
- No medication / supplements
- Non-smoker
- Low to moderately active
Key exclusion criteria (7 listed)
- Injuries
- Illness
- Use of medication
- Use of creatine in the last 3 months
- History of head trauma or seizure
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 |
|---|---|---|
| CreatineParticipants will have to supplement themselves with creatine for 7 days (20g/day). | Dietary supplement | Creatine supplementation |
| Calcium lactateParticipants will have to supplement themselves with calcium lactate for 7 days (elemental calcium: 0.780g/day). | Dietary supplement | Placebo supplementation |
Primary outcome
Cognitive performance - change in accuracy (%) during a 90-min cognitive task (i.e. Stroop task)
Time frame: During both lab visits (i.e. after both 7-day supplementation protocols); Accuracy (%) will be assessed during both lab visits with a 90-min cognitive task; Accuracy during the 90-min task will be reported as mean accuracy during 8 blocks of 11min15sec
Accuracy (in %) will be assessed during a cognitive task, this cognitive task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)
Cognitive performance - change in reaction time (milliseconds) during a 90-min cognitive task (i.e. Stroop task)
Time frame: During both lab visits (i.e. after both 7-day supplementation protocols); Reaction time (RT) will be assessed during both lab visits with a 90-min cognitive task; RT during the 90-min task will be reported as mean RT during 8 blocks of 11min15sec
Reaction time (in milliseconds) will be assessed during a cognitive task, this cognitive task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)
1 secondary outcome
Physical performance - reaction time (milliseconds) during a 7-min visuomotor reaction time task
Time frame: During both lab visits (i.e. after both 7-day supplementation protocols); visuomotor reaction time will be assessed during both lab visits with a 7-min visuomotor reaction time task.
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 8 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine and Calcium lactate in people with Healthy and Creatine Supplementation, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 6 inclusion and 7 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 8 Oct 2019. 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 Belgium. 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?
Cognitive performance - change in accuracy (%) during a 90-min cognitive task (i.e. Stroop task) (time frame: During both lab visits (i.e. after both 7-day supplementation protocols); Accuracy (%) will be assessed during both lab visits with a 90-min cognitive task; Accuracy during the 90-min task will be reported as mean accuracy during 8 blocks of 11min15sec). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.