The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW, United Kingdom
NCT Number: NCT01805700
The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive performance in patients with type 1 diabetes.
Knowledge acquired may inform a wider study of the impact of these drinks.
This is a randomised, cross over blinded study in which all participants will participate in the 3 arms of the study.
The study will consist of 3 phases, each lasting 3 days. A different study drink will be administered during each phase. There will be an initial screening visit and a pre- study visit before each study phase. Each participant will make 10 visits to the research centre.
There will be a week wash out period between each study phase. Prior to each study phase, there will be a 3 day caffeine and alcohol abstinence run-in period.
Study drinks will be matched for taste and volume (as far as possible) and will be administered by the use of opaque cups, lids and straws to enable double-blind randomisation for both researcher and participants. Administration of the study drink to participants will be based on Latin squares to provide a balanced treatment order.
During the 3 days study period; participants will be required to abstain from all other caffeine containing beverages or confectioneries.
The secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced energy drinks is developed following acute short term ingestion.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bournemouth, Dorset, BH7 7DW, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of different energy drinks
Other names: Red Bull
Glucose drink (containing 84mg glucose alone)
Time frame: Day 1, Day 2 and Day 3
Time frame: Day 1, day 2 and day 3
Time frame: Day 1, day 2 and day 3
Time frame: Day 1, day 2 and day 3
The Royal Bournemouth Hospital
Other
Effects of Acute Intake of Caffeine Enhanced Energy Drinks on Blood Glucose, Some Physiological Parameters and Cognitive Performance in Patients With Type 1 Diabetes
Acronym: REDBULL
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