Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805700
• Other study ID #: B091217
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: March 4, 2013
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Caffeine enhanced energy drink
Comparison of different energy drinks
• Glucose drink
Glucose drink (containing 84mg glucose alone)

Locations

Country	Name	City	State
United Kingdom	The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood glucose level in all patients as a measure of tolerability		Day 1, Day 2 and Day 3	No
Secondary	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		Day 1, day 2 and day 3	No
Secondary	Changes in reaction time and digit symbol substitution test score		Day 1, day 2 and day 3	No
Secondary	Changes in heart rate, systolic and diastolic blood pressure in all patients.		Day 1, day 2 and day 3	No