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van CCT (UK)

The effect of caffeine on cognitive performance and brain activity following a ‘real life’ workday - an fMRI title.

- candidate number5309
- NTR NumberNTR1671
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2009
- Secondary IDsNL26036.068.08 MEC azM/UM
- Public TitleThe effect of caffeine on cognitive performance and brain activity following a ‘real life’ workday - an fMRI title.
- Scientific TitleThe effect of caffeine on cognitive performance and brain activity following a ‘real life’ workday - an fMRI title.
- ACRONYMcaffeine and fMRI
- hypothesisThe stimulant effects of caffeine result in its common consumption by individuals in an attempt to combat the detrimental effects of fatigue on performance. However, inconsistent findings regarding the effects of caffeine on cognitive performance mean that the actions of caffeine on cognition are unclear. Further, very few studies have examined brain activity underlying caffeine induced behavioural effects. The present study will use functional magnetic resonance imaging (fMRI) to investigate the effects of acute caffeine consumption in the ‘real life’ context of habitual caffeine use on the brain activity of individuals fatigued by a ‘real life’ workday. Findings will shed light on the mechanisms whereby caffeine affects behaviour and alleviates fatigue. The study also has a much broader research aim to investigate the use of fMRI as a more sensitive tool for the detection of the effects of nutritional interventions. Functional MRI has already been demonstrated to be a more sensitive method for the detection of subtle cognitive impairment following mild traumatic brain injury, multiple sclerosis, human immunodeficiency virus and chronic fatigue syndrome. The use of fMRI provided validation of cognitive complaints in these groups where assessment using neuropsychological tasks could not. Similarly, it is hoped that fMRI will be able to provide validation of the subjective fatigue alleviating effects of nutritional interventions by demonstrating cognitive task related changes in brain activation.
- Healt Condition(s) or Problem(s) studiedFatigue
- Inclusion criteriaOnly right handed physically and mentally healthy volunteers will be included.
1. Male;
2. Moderate caffeine consumers;
3. School teachers.
- Exclusion criteriaThe exclusion criteria are based on factors which are MRI contraindications or are known to affect neuropsychological task performance, brain activity, caffeine pharmacokinetics or the safety of caffeine consumption. People who suffer from significant past or present physical or psychiatric illnesses (epilepsy, stroke, Parkinson’s disease, MS, brain surgery, brain trauma, electroshock therapy, kidney dialysis, renal dysfunction, treatment by a neurologist or psychiatrist, diabetes, heart disease, migraine, Ménière’s disease, hypertension, cardiac arrhythmias, heart palpitations, brain infections, chronic fatigue syndrome or burnout, impaired liver function, peptic ulcer disease), who currently habitually consume nicotine at any time during weekdays (due to the effect of smoking on caffeine metabolism (Nehlig, 1999) or have drug or alcohol problems, who receive medication at the moment of inclusion (in particular disulfiram, mexiletine, cimetidine, norfloxacin, enoxacin, ciprofloxacin, nonsteroidal anti-inflammatory drugs, aspirin, corticosteroids, phenylpropanolamine, monoamine oxidase inhibitors, antiarrhythmic agents and diazepam), who have an MRI contraindication (brain surgery, pacemaker, metal objects/part in body, claustrophobia, large parts of the body tattooed) or who are hypersensitive to caffeine, will be excluded from this study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-aug-2009
- Target number of participants20
- InterventionsAll participants will be tested twice: once after acute caffeinated coffee administration (100 mg caffeine, equivalent to 1 cup of coffee) and once after acute decaffeinated coffee administration (placebo).
- Primary outcomeThe main outcome measures are subjective fatigue and vitality ratings, neuropsychological performance (mean reaction time and accuracy) and the fMRI blood oxygen level dependent (BOLD) response during working memory and verbal learning tasks.
- Secondary outcomeSecondary outcome measures are the concentration of caffeine in saliva throughout the test sessions and blood glucose levels at the beginning of the test session.
- Timepoints1. Training session (fatigue assessment scale, need for recovery scale, neurovegetative scale, Dutch adult reading test);
2. 1st testing session (groningen sleep quality scale, karolinksa sleepiness scale, profile of mood state [fatigue and vitality subscales], NASA task load index, finger precueing task, short mackworth clock, letter-digit substitution test, stroop, Scanning tasks [sternberg working memory task, verbal learning task], saliva samples, blood glucose measurement);
3. 2nd testing session (1 week after 1st session: same tasks as 1st session).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryThis study aims to determine the effects of acute coffee consumption compared to consumption of decaffeinated coffee on subjective fatigue and vitality ratings, neuropsychological performance and brain activity during working memory and learning tasks. Acute effects will be investigated following a ‘real life’ workday during which caffeine was consumed according to the participant’s habitual regime.
- Main changes (audit trail)
- RECORD13-feb-2009 - 14-feb-2011

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