Cognitive FunctionNCT01376882
Cognitive and Cerebral Blood Flow Effects of 2-week Caffeine Abstinence or Maintenance
A study testing Caffeine in people with Cognitive Function and Mood, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood flow effects will also be assessed in a subset of participants. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Mood, Cerebral Haemodynamics
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Mar 2013
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male/Female
- 18 - 40 years
- Healthy
- Consume ≥ 150 mg caffeine daily
- No herbal supplements/prescription medications (excl. contraceptive pill)
- Non smoker
- Native English speaker
Who cannot join
- Diagnosis of any significant medical condition or disorder
- Any known allergy or hypersensitivity to food.
- BMI >29.9 or <18.5
- Blood pressure >139/89
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: Behavioural and Cerebral Haemodynamic Effects of Caffeine Withdrawal and Caffeine Administration Following 2-week Maintenance or Abstinence
The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood flow effects will also be assessed in a subset of participants. The role of caffeine abstinence/maintenance in the acute effects of caffeine will also be explored.
Read the detailed description
The current randomised, placebo-controlled, double-blind, parallel groups study aims to explore the behavioural effects of 2-weeks caffeine abstinence as well as establishing the role of abstinence in the effects of caffeine administration by administering caffeine or placebo to those in a state of chronic and acute abstinence. This research also aims to explore, in a subset of participants, the cerebral blood flow effects of caffeine abstinence and caffeine administration using Near Infrared Spectroscopy (NIRS). Cerebral blood flow will be measured both at rest and during performance of cognitive tasks.
- Conditions
- Cognitive Function, Mood, Cerebral Haemodynamics, Caffeine Withdrawal
- Being tested
- Placebo, Caffeine and Placebo, Placebo and Caffeine, Caffeine
- Keywords
- Caffeine, Withdrawal, Cognitive function, Mood, Cerebral haemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH. 1 Size 0 capsule 3 times a day for 14 days and 1 size 0 capsule on day 15.
Caffeine and PlaceboDietary supplement
100 mg Caffeine capsules 3 times per day for 14 days and 1 size 0 capsule of inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH on day 15.
Placebo and CaffeineDietary supplement
Inert placebo capsules containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH, 1 Size 0 capsule 3 times a day for 14 days and a 100mg caffeine capsule on day 15.
CaffeineDietary supplement
Capsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15.
| Study group | Role | What they receive |
|---|---|---|
| Acute withdrawal | Experimental | Chronic intervention 100 mg caffeine capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15. Receives: Dietary Supplement: Caffeine and Placebo |
| Acute caffeine-independent of withdrawal | Experimental | Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15. Receives: Dietary Supplement: Placebo and Caffeine |
| Chronic abstinence | Experimental | Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15. Receives: Dietary Supplement: Placebo |
| Acute caffeine-in state of withdrawal | Experimental | Chronic intervention of 100 mg caffeine capsule 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15. Receives: Dietary Supplement: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Performance is assessed using COMPASS (Computerised Mental Performance Assessment System), which presents a battery of standard cognitive tasks assessing aspects of attention and memory.
Measured: 2 weeks
Secondary outcomes (4)
Mood
Mood will be evaluated using Visual Analogue Scales administered using COMPASS.
Measured: 2 weeks
Cerebral haemodynamic
Cerebral blood flow will be measured in a subset of participants using Near Infrared Spectroscopy (NIRS).
Measured: 2 weeks
Sleep
Quality of sleep will be measured using the Pitsburgh Sleep Quality Index (PSQI).
Measured: 2 weeks
Caffeine withdrawal
Symptoms of caffeine withdrawal will be measured using a Subjective and Somatic State Questionnaire.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Haskell, Northumbria University
- Investigators
- Crystal Haskell, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376882
- Sponsor's protocol ID
- 24G4
- Status last verified
- Mar 2013
- First submitted
- 16 Jun 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural and Cerebral Haemodynamic Effects of Caffeine Withdrawal and Caffeine Administration Following 2-week Maintenance or Abstinence
- ClinicalTrials.gov ID
- NCT01376882
- Acronym / sponsor ID
- 24G4
- Conditions
- Cognitive Function, Mood, Cerebral Haemodynamics, Caffeine Withdrawal
- Keywords
- Caffeine, Withdrawal, Cognitive function, Mood, Cerebral haemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jun 2011 (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.
The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood flow effects will also be assessed in a subset of participants. The role of caffeine abstinence/maintenance in the acute effects of caffeine will also be explored.
Detailed description
The current randomised, placebo-controlled, double-blind, parallel groups study aims to explore the behavioural effects of 2-weeks caffeine abstinence as well as establishing the role of abstinence in the effects of caffeine administration by administering caffeine or placebo to those in a state of chronic and acute abstinence. This research also aims to explore, in a subset of participants, the cerebral blood flow effects of caffeine abstinence and caffeine administration using Near Infrared Spectroscopy (NIRS). Cerebral blood flow will be measured both at rest and during performance of cognitive tasks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute withdrawal | Experimental | Dietary Supplement: Caffeine and PlaceboChronic intervention 100 mg caffeine capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15. |
| Acute caffeine-independent of withdrawal | Experimental | Dietary Supplement: Placebo and CaffeineChronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15. |
| Chronic abstinence | Experimental | Dietary Supplement: PlaceboChronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15. |
| Acute caffeine-in state of withdrawal | Experimental | Dietary Supplement: CaffeineChronic intervention of 100 mg caffeine capsule 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male/Female
- 18 - 40 years
- Healthy
- Consume ≥ 150 mg caffeine daily
- No herbal supplements/prescription medications (excl. contraceptive pill)
Key exclusion criteria (4 listed)
- Diagnosis of any significant medical condition or disorder
- Any known allergy or hypersensitivity to food.
- BMI >29.9 or <18.5
- Blood pressure >139/89
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 |
|---|---|---|
| PlaceboInert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH. 1 Size 0 capsule 3 times a day for 14 days and 1 size 0 capsule on day 15. | Dietary supplement | Chronic abstinence |
| Caffeine and Placebo100 mg Caffeine capsules 3 times per day for 14 days and 1 size 0 capsule of inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH on day 15. | Dietary supplement | Acute withdrawal |
| Placebo and CaffeineInert placebo capsules containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH, 1 Size 0 capsule 3 times a day for 14 days and a 100mg caffeine capsule on day 15. | Dietary supplement | Acute caffeine-independent of withdrawal |
| CaffeineCapsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15. | Dietary supplement | Acute caffeine-in state of withdrawal |
Primary outcome
Cognitive performance
Time frame: 2 weeks
Performance is assessed using COMPASS (Computerised Mental Performance Assessment System), which presents a battery of standard cognitive tasks assessing aspects of attention and memory.
4 secondary outcomes
Mood
Time frame: 2 weeks
Cerebral haemodynamic
Time frame: 2 weeks
Sleep
Time frame: 2 weeks
Caffeine withdrawal
Time frame: 2 weeks
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 29 Mar 2013.
- COMPASS softwareLink provided by the sponsor.
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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.
Crystal Haskell, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Cognitive Function and Mood, run by Northumbria University at 1 site in United Kingdom.
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 7 inclusion and 4 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 29 Mar 2013. 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 United Kingdom. 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. 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 (time frame: 2 weeks). 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 29 Mar 2013.