Effects of Low Doses of Caffeine on Mood, Physiology and Mental Function
| Tracking Information | |||||
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| First Received Date ICMJE | June 15, 2007 | ||||
| Last Updated Date | June 15, 2007 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Assessment of memory, attention, reaction time and subjective mood, measurement of heart rate and blood pressure. Co-monitoring of salivary caffeine levels. [ Time Frame: baseline, 1 hour, 3 hours, 6 hours and 9 hours ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Low Doses of Caffeine on Mood, Physiology and Mental Function | ||||
| Official Title ICMJE | Levels of Caffeine Lower Than Those Found in Decaffeinated Beverages Exert Effects on Cognition, Mood, and Autonomic Activity | ||||
| Brief Summary | It is often assumed that levels of caffeine found in ‘decaffeinated’ beverages are below any psychopharmacological threshold. However, recent findings indicate that caffeine doses as low as 9 mg may be psychoactive. The effects of caffeine have also been shown up to 6 hours post-administration. The study aimed to establish the lowest active dose of caffeine, and to ascertain the duration of any effects. |
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| Detailed Description | The majority of recent caffeine studies have evaluated doses in the range of 75 – 150 mg or 1 – 2 mg/kg (approximately 130 - 260 ml fresh coffee). Such doses produce well characterised effects; including increased ‘alertness’, and improvements to measures of reaction time and sustained attention. A previous study has demonstrated improvements to performance following 9 mg caffeine, which represents the lowest known psychoactive dose of caffeine. A number of these effects, including elevated salivary caffeine levels, were still apparent at 6 hours post-caffeine consumption (9). Findings showing effects of 12.5 and 9 mg caffeine are important as these are approaching the levels found in decaffeinated beverages, which are assumed to have no behavioural or physiological effects. However, despite extensive research in this area, the lower threshold for psychoactive effects has not been established. A randomised, placebo-controlled, double-blind, balanced crossover study was undertaken. 20 young men and women (13 female, mean age 20.7 years, SD 2.4) undertook computerised assessments of memory and attention and rated subjective mood. Autonomic activity and salivary caffeine were co-monitored. Assessment took place at baseline, 1, 3, 6, and 9 hours post-administration of placebo, 2.5, 5, and 10 mg caffeine (on separate days) administered in 150 ml fruit juice. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: caffeine | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | November 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00487227 | ||||
| Other Study ID Numbers ICMJE | 7G2CDCH | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Northumbria University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Northumbria University | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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