Cognitive Function Clinical Trial
Official title:
Behavioural and Cerebral Haemodynamic Effects of Caffeine Withdrawal and Caffeine Administration Following 2-week Maintenance or Abstinence
Verified date | March 2013 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Male/Female - 18 - 40 years - Healthy - Consume = 150 mg caffeine daily - No herbal supplements/prescription medications (excl. contraceptive pill) - Non smoker - Native English speaker Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Brain, Performance and Nutrition Research Centre, Northumbria University | Newcastle-upon-Tyne | Tyne and Wear |
Lead Sponsor | Collaborator |
---|---|
Northumbria University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 weeks | No |
Secondary | Mood | Mood will be evaluated using Visual Analogue Scales administered using COMPASS. | 2 weeks | No |
Secondary | Cerebral haemodynamic | Cerebral blood flow will be measured in a subset of participants using Near Infrared Spectroscopy (NIRS). | 2 weeks | No |
Secondary | Sleep | Quality of sleep will be measured using the Pitsburgh Sleep Quality Index (PSQI). | 2 weeks | No |
Secondary | Caffeine withdrawal | Symptoms of caffeine withdrawal will be measured using a Subjective and Somatic State Questionnaire. | 2 weeks | No |
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