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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01376882
Other study ID # 24G4
Secondary ID
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


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
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