HealthyCaffeineNCT02647567
Caffeine Intake and Additive Effects on Cognition
A study testing Caffeine Intake in people with Healthy, run by Universidade Federal do Rio de Janeiro.
Trial summary
Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant properties, and their intake when in moderate doses seem to produce positive effects on stress, mood and memory. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caffeine Intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fighting men
- Low levels of consumption of caffeine daily
Who cannot join
- Use more than 400 mg caffeine day
- Mental diseases
- Cognitive deficits
About this study
Official title: Can Caffeine Intake Combined With Aerobic Exercise Leads to Cognitive Improvement and Psychomotor Performance in Trained Individuals?
Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant properties, and their intake when in moderate doses seem to produce positive effects on stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be displayed also on cognition, as caffeine, when in proper proportions, the investigators do not know if the joining of the two strategies into a single activity would be able to promote additional effects enhancing cognitive processes related to memory, attention, and motor reaction time.
Read the detailed description
Determine if 500 mg of caffeine can generate additional effects to 30 minutes of aerobic exercise enhancing cognitive memory tasks (Rey Auditory Verbal Learning Test - RAVLT), attention (sustained attention span; working speed; Percentual of errors by confusion) and simple reaction time (SRT).
- Conditions
- Healthy
- Being tested
- Caffeine Intake, Placebo Intake
- Keywords
- Cognitive, Aerobic Exercise, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine IntakeOther
Also called Caffeine
The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.
Placebo IntakeOther
Also called Placebo
The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Intake | Experimental | The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests. Receives: Other: Caffeine Intake |
| Placebo Intake | Placebo comparator | The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests. Receives: Other: Placebo Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Reaction Time
Measured: Acute Change from Baseline Psychomotor test to 1 min after aerobic exercise, and after 30 min
Rey Auditory Verbal Learning Test
Measured: Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min
Sustained Attention Test
Measured: Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionDec 2015
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Souza de Sá Filho, Universidade Federal do Rio de Janeiro
- Investigators
- Sérgio Machado, PhD, Study director, Salgado de Oliveira University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647567
- Sponsor's protocol ID
- UNIVERSO-03
- Acronym
- Caffeine
- Status last verified
- Jan 2016
- First submitted
- 5 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Caffeine Intake Combined With Aerobic Exercise Leads to Cognitive Improvement and Psychomotor Performance in Trained Individuals?
- ClinicalTrials.gov ID
- NCT02647567
- Acronym / sponsor ID
- Caffeine / UNIVERSO-03
- Conditions
- Healthy
- Keywords
- Cognitive, Aerobic Exercise, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Jan 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.
Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant properties, and their intake when in moderate doses seem to produce positive effects on stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be displayed also on cognition, as caffeine, when in proper proportions, the investigators do not know if the joining of the two strategies into a single activity would be able to promote additional effects enhancing cognitive processes related to memory, attention, and motor reaction time.
Detailed description
Determine if 500 mg of caffeine can generate additional effects to 30 minutes of aerobic exercise enhancing cognitive memory tasks (Rey Auditory Verbal Learning Test - RAVLT), attention (sustained attention span; working speed; Percentual of errors by confusion) and simple reaction time (SRT).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine Intake | Experimental | Other: Caffeine IntakeThe experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests. |
| Placebo Intake | Placebo comparator | Other: Placebo IntakeThe control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fighting men
- Low levels of consumption of caffeine daily
Key exclusion criteria (3 listed)
- Use more than 400 mg caffeine day
- Mental diseases
- Cognitive deficits
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 |
|---|---|---|
| Caffeine IntakeAlso: CaffeineThe experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests. | Other | Caffeine Intake |
| Placebo IntakeAlso: PlaceboThe control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests. | Other | Placebo Intake |
Primary outcome
Simple Reaction Time
Time frame: Acute Change from Baseline Psychomotor test to 1 min after aerobic exercise, and after 30 min
Rey Auditory Verbal Learning Test
Time frame: Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min
Sustained Attention Test
Time frame: Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min
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 6 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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.
Sérgio Machado, PhD study director
Salgado de Oliveira University
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine Intake in people with Healthy, run by Universidade Federal do Rio de Janeiro.
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 3 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Simple Reaction Time (time frame: Acute Change from Baseline Psychomotor test to 1 min after aerobic exercise, and after 30 min). The study lists 3 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 6 Jan 2016.