Type 1 DiabetesREDBULLNCT01805700
Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes
A study testing Caffeine enhanced energy drink and Glucose drink in people with Type 1 Diabetes, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Caffeine enhanced energy drink and Glucose drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypoglycaemia unawareness
- Coronary heart disease
- Cardiac arrhythmia
- Structural heart lesions,
- Autonomic neuropathy
- Psychiatry illness,
Show all 10Show fewer
- Epilepsy
- Migraine
- Caffeine intolerance
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW
About this study
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.
Read more
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Caffeine enhanced energy drink, Glucose drink
- Keywords
- type 1, diabetes, caffeine-enhanced energy drink, cardiac output, glucose, cognitive performance
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine enhanced energy drinkOther
Also called Red Bull
Comparison of different energy drinks
Glucose drinkOther
Glucose drink (containing 84mg glucose alone)
| Study group | Role | What they receive |
|---|---|---|
| Regular caffeine enhanced energy drink | Experimental | Regular caffeine enhanced energy drink (containing 240mg caffeine \& 84g glucose) e.g. regular red bull cans (x3) Receives: Other: Caffeine enhanced energy drink |
| Diet Caffeine enhanced energy drink | Experimental | Diet Caffeine enhanced energy drink ( containing 240mg of caffeine alone) e.g. Red Bull light) Receives: Other: Caffeine enhanced energy drink |
| Glucose drink | Active comparator | Glucose drink (containing 84g glucose alone) Receives: Other: Glucose drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood glucose level in all patients as a measure of tolerability
Measured: Day 1, Day 2 and Day 3
Secondary outcomes (3)
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
Measured: Day 1, day 2 and day 3
Changes in reaction time and digit symbol substitution test score
Measured: Day 1, day 2 and day 3
Changes in heart rate, systolic and diastolic blood pressure in all patients.
Measured: Day 1, day 2 and day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tolulope Olateju, MRCP, Principal investigator, The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805700
- Sponsor's protocol ID
- B091217
- Acronym
- REDBULL
- Status last verified
- Mar 2013
- First submitted
- 28 Feb 2013
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01805700
- Acronym / sponsor ID
- REDBULL / B091217
- Conditions
- Type 1 Diabetes
- Keywords
- type 1, diabetes, caffeine-enhanced energy drink, cardiac output, glucose, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular caffeine enhanced energy drink | Experimental | Other: Caffeine enhanced energy drinkRegular caffeine enhanced energy drink (containing 240mg caffeine \& 84g glucose) e.g. regular red bull cans (x3) |
| Diet Caffeine enhanced energy drink | Experimental | Other: Caffeine enhanced energy drinkDiet Caffeine enhanced energy drink ( containing 240mg of caffeine alone) e.g. Red Bull light) |
| Glucose drink | Active comparator | Other: Glucose drinkGlucose drink (containing 84g glucose alone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Hypoglycaemia unawareness
- Coronary heart disease
- Cardiac arrhythmia
- Structural heart lesions,
- Autonomic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine enhanced energy drinkAlso: Red BullComparison of different energy drinks | Other | Diet Caffeine enhanced energy drink, Regular caffeine enhanced energy drink |
| Glucose drinkGlucose drink (containing 84mg glucose alone) | Other | Glucose drink |
Primary outcome
Changes in blood glucose level in all patients as a measure of tolerability
Time frame: Day 1, Day 2 and Day 3
3 secondary outcomes
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
Changes in reaction time and digit symbol substitution test score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tolulope Olateju, MRCP principal investigator
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine enhanced energy drink and Glucose drink in people with Type 1 Diabetes, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood glucose level in all patients as a measure of tolerability (time frame: Day 1, Day 2 and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.