Cognitive and Cerebral Blood Flow Effects of 2-week Caffeine Abstinence or Maintenance

Cognitive Function Clinical Trial

Official title:

Behavioural and Cerebral Haemodynamic Effects of Caffeine Withdrawal and Caffeine Administration Following 2-week Maintenance or Abstinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376882
• Other study ID #: 24G4
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: March 28, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. The role of caffeine abstinence/maintenance in the acute effects of caffeine will also be explored.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Caffeine Withdrawal
• Cerebral Haemodynamics
• Cognitive Function
• Mood

Intervention

Dietary Supplement:
• Placebo
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 Placebo
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 Caffeine
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.
• Caffeine
Capsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15.

Locations

Country	Name	City	State
United Kingdom	Brain, Performance and Nutrition Research Centre, Northumbria University	Newcastle-upon-Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

•   Brain, Performance and Nutrition Research Centre, Northumbria University
•   COMPASS software