NCT01805700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

1.4 years

First QC Date

February 28, 2013

Last Update Submit

March 4, 2013

Conditions

Type 1 Diabetes

Keywords

type 1diabetescaffeine-enhanced energy drinkcardiac outputglucosecognitive performance

Outcome Measures

Primary Outcomes (1)

  • Changes in blood glucose level in all patients as a measure of tolerability

    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

    Day 1, day 2 and day 3

  • Changes in reaction time and digit symbol substitution test score

    Day 1, day 2 and day 3

  • Changes in heart rate, systolic and diastolic blood pressure in all patients.

    Day 1, day 2 and day 3

Study Arms (3)

Regular caffeine enhanced energy drink

EXPERIMENTAL

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

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)

Other: Caffeine enhanced energy drink

Glucose drink

ACTIVE COMPARATOR

Glucose drink (containing 84g glucose alone)

Other: Glucose drink

Interventions

Caffeine enhanced energy drinkOTHER

Comparison of different energy drinks

Also known as: Red Bull
Diet Caffeine enhanced energy drinkRegular caffeine enhanced energy drink
Glucose drinkOTHER

Glucose drink (containing 84mg glucose alone)

Glucose drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hypoglycaemia unawareness
  • Coronary heart disease
  • Cardiac arrhythmia
  • Structural heart lesions,
  • Autonomic neuropathy
  • Psychiatry illness,
  • Epilepsy
  • Migraine
  • Caffeine intolerance
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Tolulope Olateju, MRCP

    The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 6, 2013

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

GB(1)