Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes (REDBULL)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Caffeine enhanced energy drink
Glucose drink
Sponsored by
About this trial
This is an interventional health services research trial for Type 1 Diabetes focused on measuring type 1, diabetes, caffeine-enhanced energy drink, cardiac output, glucose, cognitive performance
Eligibility Criteria
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
Sites / Locations
- The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Regular caffeine enhanced energy drink
Diet Caffeine enhanced energy drink
Glucose drink
Arm Description
Regular caffeine enhanced energy drink (containing 240mg caffeine & 84g glucose) e.g. regular red bull cans (x3)
Diet Caffeine enhanced energy drink ( containing 240mg of caffeine alone) e.g. Red Bull light)
Glucose drink (containing 84g glucose alone)
Outcomes
Primary Outcome Measures
Changes in blood glucose level in all patients as a measure of tolerability
Secondary Outcome Measures
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
Changes in reaction time and digit symbol substitution test score
Changes in heart rate, systolic and diastolic blood pressure in all patients.
Full Information
NCT ID
NCT01805700
First Posted
February 28, 2013
Last Updated
March 4, 2013
Sponsor
The Royal Bournemouth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01805700
Brief Title
Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes
Acronym
REDBULL
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Bournemouth Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1, diabetes, caffeine-enhanced energy drink, cardiac output, glucose, cognitive performance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular caffeine enhanced energy drink
Arm Type
Experimental
Arm Description
Regular caffeine enhanced energy drink (containing 240mg caffeine & 84g glucose) e.g. regular red bull cans (x3)
Arm Title
Diet Caffeine enhanced energy drink
Arm Type
Experimental
Arm Description
Diet Caffeine enhanced energy drink ( containing 240mg of caffeine alone) e.g. Red Bull light)
Arm Title
Glucose drink
Arm Type
Active Comparator
Arm Description
Glucose drink (containing 84g glucose alone)
Intervention Type
Other
Intervention Name(s)
Caffeine enhanced energy drink
Other Intervention Name(s)
Red Bull
Intervention Description
Comparison of different energy drinks
Intervention Type
Other
Intervention Name(s)
Glucose drink
Intervention Description
Glucose drink (containing 84mg glucose alone)
Primary Outcome Measure Information:
Title
Changes in blood glucose level in all patients as a measure of tolerability
Time Frame
Day 1, Day 2 and Day 3
Secondary Outcome Measure Information:
Title
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
Title
Changes in reaction time and digit symbol substitution test score
Time Frame
Day 1, day 2 and day 3
Title
Changes in heart rate, systolic and diastolic blood pressure in all patients.
Time Frame
Day 1, day 2 and day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tolulope Olateju, MRCP
Organizational Affiliation
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
12. IPD Sharing Statement
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Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes
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