NCT02940808

Brief Summary

Cognitive control driven by the prefrontal cortex (PFC) of the brain is thought to be important for goal-directed control over stimulus-driven processes. EEG-measured spontaneous theta/beta ratio (TBR) may potentially be used as an electrophysiological marker for this PFC-mediated cognitive control. In the present study the investigators further examine TBR as an electrophysiological marker for cognitive control, by administering caffeine to forty healthy female participants. After a first training session, participants will visit the lab twice in separate weeks, during which they will orally consume one capsule containing 200mg of caffeine, and one capsule containing a placebo substance (double-blind and random order of administration). EEG will be measured before and after capsule consumption, and cognitive control tasks will be administered after capsule consumption. Generally, the investigators expect that caffeine will decrease TBR and thereby increase cognitive control. Additionally, the investigators expect that individual differences in baseline frontal (reflected by TBR) and central dopaminergic (reflected by spontaneously-measured eye-blink rates; EBR) activity will moderate the relationship between caffeine and cognitive control. Furthermore, the effects of caffeine on specifically hypervigilance for threatening distractors (taking into account a possible moderating role of trait anxiety) were examined as a separate research question.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

October 17, 2016

Last Update Submit

March 7, 2017

Conditions

Caffeine

Keywords

CaffeineEEGTheta/beta ratioEye-blink ratesCognitive controlEmotional StroopGlobal/local congruencyN-BackPrefrontal Cortex

Outcome Measures

Primary Outcomes (9)

  • Attentional focus (RT)

    TACT focus RTs on incongruent v congruent (correct) trials.

    Approx. 45 min after capsule consumption

  • Attentional shift (RT)

    TACT shift RTs on post-shift trials compared to pre-shift (correct) trials.

    Approx. 45 min after capsule consumption

  • Emotional interference (RT)

    Emotional Stroop Task RTs for neutral, positive, and negative (correct) trials.

    Approx. 70 min after capsule consumption

  • EEG theta/beta ratio

    For mediation analyses, change in EEG theta/beta ratio after caffeine consumption relative to placebo consumption.

    Approx. 30 min after capsule consumption

  • EEG theta/beta ratio

    For moderation analyses, baseline-measured spontaneous EEG theta/beta ratio.

    Baseline

  • Spontaneous eye-blink rates

    For moderation analyses, baseline-measured spontaneous eye-blink rates.

    Baseline

  • Trait anxiety

    Self-reported trait anxiety (STAI-t)

    Baseline

  • Working memory (ACC)

    N-Back accuracy (% correct) in the 1-back and 3-back conditions.

    Approx. 60 min after capsule consumption

  • Working memory (RT)

    N-Back RTs on correct trials in the 1-back and 3-back conditions.

    Approx. 60 min after capsule consumption

Secondary Outcomes (2)

  • Attentional focus (ACC)

    Approx. 45 min after capsule consumption

  • Attentional shift (ACC)

    Approx. 45 min after capsule consumption

Other Outcomes (2)

  • TBR and ACS

    Baseline

  • TBR and STAI-t

    Baseline

Study Arms (2)

Caffeine first, placebo second

OTHER

Caffeine consumption during session 1, placebo consumption during session 2 (after baseline session "0").

Dietary Supplement: Caffeine (200mg)Other: Placebo

Placebo first, caffeine second

OTHER

Placebo consumption during session 1, caffeine consumption during session 2 (after baseline session "0").

Dietary Supplement: Caffeine (200mg)Other: Placebo

Interventions

Caffeine (200mg)DIETARY_SUPPLEMENT

Oral consumption of capsule containing 200mg caffeine.

Caffeine first, placebo secondPlacebo first, caffeine second
PlaceboOTHER

Oral consumption of capsule containing a placebo substance.

Caffeine first, placebo secondPlacebo first, caffeine second

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Female
  • Age 18-26 years
  • Consuming less than 100mg of caffeine (about one cup of coffee) per day on average (evaluated using pre-defined caffeine contents, e.g.: coffee: 85mg/cup; cappuccino: 100mg/cup; tea: 40mg/cup; cola: 18mg/cup; energy drink: 80mg/can)
  • Fluent in Dutch language
  • Severe physical or psychological morbidity that would adversely affect participation
  • Habitual smoking
  • Use of psychopharmaceuticals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University

Leiden, South Holland, 2333AK, Netherlands

Location

Related Publications (14)

  • Putman P, van Peer J, Maimari I, van der Werff S. EEG theta/beta ratio in relation to fear-modulated response-inhibition, attentional control, and affective traits. Biol Psychol. 2010 Feb;83(2):73-8. doi: 10.1016/j.biopsycho.2009.10.008. Epub 2009 Nov 6.

    PMID: 19897008BACKGROUND

  • Putman P, Verkuil B, Arias-Garcia E, Pantazi I, van Schie C. EEG theta/beta ratio as a potential biomarker for attentional control and resilience against deleterious effects of stress on attention. Cogn Affect Behav Neurosci. 2014 Jun;14(2):782-91. doi: 10.3758/s13415-013-0238-7.

    PMID: 24379166BACKGROUND

  • Jongkees BJ, Colzato LS. Spontaneous eye blink rate as predictor of dopamine-related cognitive function-A review. Neurosci Biobehav Rev. 2016 Dec;71:58-82. doi: 10.1016/j.neubiorev.2016.08.020. Epub 2016 Aug 21.

    PMID: 27555290BACKGROUND

  • Cools R, D'Esposito M. Inverted-U-shaped dopamine actions on human working memory and cognitive control. Biol Psychiatry. 2011 Jun 15;69(12):e113-25. doi: 10.1016/j.biopsych.2011.03.028. Epub 2011 May 4.

    PMID: 21531388BACKGROUND

  • Eysenck MW, Derakshan N, Santos R, Calvo MG. Anxiety and cognitive performance: attentional control theory. Emotion. 2007 May;7(2):336-53. doi: 10.1037/1528-3542.7.2.336.

    PMID: 17516812BACKGROUND

  • Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.

    PMID: 10945922BACKGROUND

  • Karson CN. Spontaneous eye-blink rates and dopaminergic systems. Brain. 1983 Sep;106 (Pt 3):643-53. doi: 10.1093/brain/106.3.643.

    PMID: 6640274BACKGROUND

  • Barry RJ, Clarke AR, Johnstone SJ. A review of electrophysiology in attention-deficit/hyperactivity disorder: I. Qualitative and quantitative electroencephalography. Clin Neurophysiol. 2003 Feb;114(2):171-83. doi: 10.1016/s1388-2457(02)00362-0.

    PMID: 12559224BACKGROUND

  • Einother SJ, Giesbrecht T. Caffeine as an attention enhancer: reviewing existing assumptions. Psychopharmacology (Berl). 2013 Jan;225(2):251-74. doi: 10.1007/s00213-012-2917-4. Epub 2012 Dec 16.

    PMID: 23241646BACKGROUND

  • Derryberry D, Reed MA. Anxiety-related attentional biases and their regulation by attentional control. J Abnorm Psychol. 2002 May;111(2):225-36. doi: 10.1037//0021-843x.111.2.225.

    PMID: 12003445BACKGROUND

  • Smillie LD, Gokcen E. Caffeine enhances working memory for extraverts. Biol Psychol. 2010 Dec;85(3):496-8. doi: 10.1016/j.biopsycho.2010.08.012. Epub 2010 Sep 15.

    PMID: 20816912BACKGROUND

  • Arnsten AF. Stress signalling pathways that impair prefrontal cortex structure and function. Nat Rev Neurosci. 2009 Jun;10(6):410-22. doi: 10.1038/nrn2648.

    PMID: 19455173BACKGROUND

  • Gratton G, Coles MG, Donchin E. A new method for off-line removal of ocular artifact. Electroencephalogr Clin Neurophysiol. 1983 Apr;55(4):468-84. doi: 10.1016/0013-4694(83)90135-9.

    PMID: 6187540BACKGROUND

  • Kooij JJ, Buitelaar JK, van den Oord EJ, Furer JW, Rijnders CA, Hodiamont PP. Internal and external validity of attention-deficit hyperactivity disorder in a population-based sample of adults. Psychol Med. 2005 Jun;35(6):817-27. doi: 10.1017/s003329170400337x.

    PMID: 15997602BACKGROUND

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Peter Putman, PhD

    Leiden University, Clinical Psychology Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 21, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 8, 2017

Record last verified: 2017-03

Locations

NL(1)