Type 1 Diabetes Clinical Trial
Official title:
Effects of Acute Intake of Caffeine Enhanced Energy Drinks on Blood Glucose, Some Physiological Parameters and Cognitive Performance in Patients With Type 1 Diabetes
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.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
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