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Completed

NCT Number: NCT01805700

Effects of Acute Intake of Caffeinated Beverages in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, Dorset, BH7 7DW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adults aged ≥18 years
  • Confirmed diagnosis of Type 1 diabetes of more than one year duration
  • Participants who use multiple daily injections of basal and meal-time analogue insulin.
  • Ability to perform daily finger stick measurements of blood glucose levels
  • Adequate contraceptive control
  • Provision of informed consent

Exclusion criteria

  • Hypoglycaemia unawareness
  • Coronary heart disease
  • Cardiac arrhythmia
  • Structural heart lesions,
  • Autonomic neuropathy
  • Psychiatry illness,
  • Epilepsy
  • Migraine
  • Caffeine intolerance
  • Unable to provide informed consent

Treatment and study plan

Caffeine enhanced energy drink

Other

Comparison of different energy drinks

Other names: Red Bull

Glucose drink

Other

Glucose drink (containing 84mg glucose alone)

Primary outcomes

  1. Changes in blood glucose level in all patients as a measure of tolerability

    Time frame: Day 1, Day 2 and Day 3

Secondary outcomes

  1. The effects on certain mood states, e.g. energetic arousal, tense arousal and hedonic tone following the consumption of caffeinated energy drinks in comparison with caffeine free glucose in patients with type 1 diabetes

    Time frame: Day 1, day 2 and day 3

  2. Changes in reaction time and digit symbol substitution test score

    Time frame: Day 1, day 2 and day 3

  3. Changes in heart rate, systolic and diastolic blood pressure in all patients.

    Time frame: Day 1, day 2 and day 3

Sponsors and collaborators

Lead sponsor

The Royal Bournemouth Hospital

Other

Registry information

Official study 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

Acronym: REDBULL

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2013
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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