Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes (REDBULL)

March 4, 2013 updated by: The Royal Bournemouth Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Regular caffeine enhanced energy drink
Regular caffeine enhanced energy drink (containing 240mg caffeine & 84g glucose) e.g. regular red bull cans (x3)
Other: Caffeine enhanced energy drink
Comparison of different energy drinks
Other Names:
  • Red Bull
EXPERIMENTAL: Diet Caffeine enhanced energy drink
Diet Caffeine enhanced energy drink ( containing 240mg of caffeine alone) e.g. Red Bull light)
Other: Caffeine enhanced energy drink
Comparison of different energy drinks
Other Names:
  • Red Bull
ACTIVE_COMPARATOR: Glucose drink
Glucose drink (containing 84g glucose alone)
Other: Glucose drink
Glucose drink (containing 84mg glucose alone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in blood glucose level in all patients as a measure of tolerability
Time Frame: Day 1, Day 2 and Day 3
Day 1, Day 2 and Day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 1, day 2 and day 3
Changes in reaction time and digit symbol substitution test score
Time Frame: Day 1, day 2 and day 3
Day 1, day 2 and day 3
Changes in heart rate, systolic and diastolic blood pressure in all patients.
Time Frame: Day 1, day 2 and day 3
Day 1, day 2 and day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Bournemouth Hospital

Investigators

  • Principal Investigator: Tolulope Olateju, MRCP, The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (ESTIMATE)

March 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B091217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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