The short term effects of coffee and caffeine on the cardiovascular and autonomic nervous systems
| ISRCTN | ISRCTN11339389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11339389 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/05/2009
- Registration date
- 12/08/2009
- Last edited
- 06/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Michael McMullen
Scientific
Scientific
Box 65
Vaddo
76040
Sweden
| research@micmcmullen.se |
Study information
| Study design | Crossover, double blind, placebo-controlled, randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The short term effects of coffee and caffeine on the cardiovascular and autonomic nervous systems: a crossover, double blind, placebo-controlled and cohort randomised clinical trial |
| Study objectives | Coffee and caffeine have/do not have an effect on the autonomic system as measured by changes of cardiac parameters and breathing frequency. This study uses two research models to investigate the short term effects (up to one hour) of coffee and caffeine preparations on the autonomic nerve system and recordings are made of cardiovascular parameters and breathing frequency. The first model involves pre-test recording with post-test recording 30 and 60 minutes after administration. The second model uses continuous recordings for 45 minutes after administration of the test substance. Testing is carried out in supine, sitting and upright postures. The third and fourth models included physiological recordings. Recordings undertaken: 1. Recording of cardiovascular parameters with Finometer-finger pulse contour measures providing measures of blood pressure, heart rate, ejection time, diastolic interval, dp/dt, diastolic pressure time index (DTPI), systolic pressure time index (SPTI), DPTI/SPTI, stroke volume, cardiac output, peripheral resistance, aortic impedance and arterial compliance 2. Recording of breathing frequency with Biopac Respiratory Effort Transducer (TSD201) attached to Finometer 3. R-R (heart beat) recordings with Nerve Express using a Polar thoracic band - used for determining heart rate variability measures |
| Ethics approval(s) | Approved by the University of Westminster Ethics Committee on the 8th April 2004 (ref: 03/04-08) |
| Health condition(s) or problem(s) studied | Cardiovascular and autonomic nervous system functioning |
| Intervention | Each model was conducted over time and only one model was recruited for at a time. All models were crossover. Patients will be randomised to: 1. Placebo capsule 2. Caffeine capsule (67, 133, 200 mg) 3. Espresso coffee (16.5 mg caffeine) 4. Espresso coffee and caffeine/placebo capsule The designs of the different models were as follows: Model design 1: Participants were monitored for 90s continuous recordings at 30 minutes and 60 minutes after intervention. The equipment is attached for 15 - 20 minutes each test period and between recording periods the equipment is removed. There are three recording periods per session: pre intervention and post intervention at 30 minutes and 60 minutes. Model design 2: Participants were monitored by a continuous recording which includes pre-intervention recording (baseline) and extends for 35 to 40 minutes after intervention. Continuous recordings of breathing and the cardiovascular system for approximately 45 minutes. The equipment is not removed from the participant during the experimental session. There is only one test period per session. Model design 3: Initially uncontrolled breathing, then alternating frequency (0.167 Hz/0.250 Hz). Recording for 270s in supine and upright postures. Model design 4: Recording for 270s with particpants engaging in four activities (lying, standing, cycling with heart rate: 115 bpm, cycling with heart rate: 135 bpm), presented in the same order for all participants. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Coffee, caffeine |
| Primary outcome measure | Pre-planned comparisons to placebo conditions: 1. The cardiovascular parameters derived from the Finometer recordings of the finger pulse contour (www.finapres.com): systolic, diastolic and mean blood pressure, heart rate, ejection time, diastolic interval, dp/dt, DPTI, SPTI, DPTI/SPTI, ejection time, stroke volume, cardiac output, total peripheral resistance, aortic impedance and arterial compliance 2. Breathing rate Timepoints: Model 1: recording 30 and 60 minutes after intervention; test session 15 minutes Model 2: constant recording for 40 minutes after intervention |
| Secondary outcome measures | 1. Pre planned comparisons of intervention effects in different postures 2. Variability analysis of Finometer derived cardiovascular parameters as appropriate in a post experimental analysis 3. Dosage relationships Timepoints: Model 1: recording 30 and 60 minutes after intervention; test session 15 minutes Model 2: constant recording for 40 minutes after intervention |
| Overall study start date | 01/10/2004 |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 105 participants |
| Key inclusion criteria | 1. Voluntary recruits from the students, staff and associates of the University of Westminster 2. Non-medicated 3. Normotensive 4. Aged 18 to 63 years, either sex 5. Habitual caffeine users (consumption of tea or coffee on a daily basis) or non caffeine users (less than 3 servings per week) Model 4 only: 6. Regular cyclists |
| Key exclusion criteria | 1. Pregnant and breast feeding women 2. Hypertensive (blood pressure greater than 140/90 mmHg) 3. Users of prescribed medicines For models 1 and 2: 4. Smokers |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 01/03/2009 |
Locations
Countries of recruitment
- Sweden
- United Kingdom
Study participating centre
Box 65
Vaddo
76040
Sweden
76040
Sweden
Sponsor information
University of Westminster (UK)
University/education
University/education
c/o Dr Julie Whitehouse
School of Life Sciences
115 New Cavendish Street
London
W1W 6UW
England
United Kingdom
| Website | http://www.wmin.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04ycpbx82 |
Funders
Funder type
University/education
University of Westminster (UK) - PhD study (self-funded) at the School of Life Sciences
No information available
Donations received from:
No information available
Whitehorse Nutriceuticals (UK) - Dr Brian Whitton donated caffeine capsules,
No information available
Naturally Scientific (UK) - HPLC testing of caffeine levels in espresso coffees by Peter Whitton
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No | |
| Results article | results | 01/09/2012 | Yes | No |
