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

The Royal Bournemouth Hospital

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Caffeine enhanced energy drink; Other: Glucose drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01805700

B091217

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Regular caffeine enhanced energy drink

Experimental group

Description:

Regular caffeine enhanced energy drink (containing 240mg caffeine \& 84g glucose) e.g. regular red bull cans (x3)

Treatment:

Other: Caffeine enhanced energy drink

Diet Caffeine enhanced energy drink

Experimental group

Description:

Diet Caffeine enhanced energy drink ( containing 240mg of caffeine alone) e.g. Red Bull light)

Treatment:

Other: Caffeine enhanced energy drink

Glucose drink

Active Comparator group

Description:

Glucose drink (containing 84g glucose alone)

Treatment:

Other: Glucose drink