Acute effects of coffee on endothelial function and glucose metabolism in healthy volunteers

ISRCTN	ISRCTN85096812
DOI	https://doi.org/10.1186/ISRCTN85096812
Protocol serial number	02/2007
Sponsor	University of Palermo (Italy)
Funders	Italian Ministry of the University of Scientific and Technological Research (Ministero Dell'università E Della Ricerca Scientifica E Tectnologica [MURST]) (Italy), Coffee to be tested is offered by Morettino s.p.a. Palermo (Italy)

Submission date: 31/10/2007
Registration date: 06/11/2007
Last edited: 04/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Silvio Buscemi
Scientific

Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Via del Vespro, 129
Palermo
90127
Italy

Study information

Primary study design	Interventional
Study design	Randomised, crossed, double-blind, placebo controlled study
Secondary study design	Randomised controlled trial
Scientific title	Acute effects of coffee on endothelial function and glucose metabolism in healthy volunteers
Study objectives	Please note that as of 15/05/2008 this trial record was extensively amended. Most of the changes to this record can be found in the relevant field, under the date on which the amendment was made. The following changes have also taken place: 1. The total number of participants has been amended from 20 to 50 2. Only 20 of the 50 participants were assessed for all primary and secondary outcome measures, whereas the remaining 30 participants were assessed only for the QTc intervals (secondary outcome field no. 3). Please see Primary/Secondary outcome measures field for detail. Study hypothesis: Caffeine or unknown components of coffee might acutely influence endothelial function as well as glucose metabolism.
Ethics approval(s)	Ethics approval received from the Local Ethical Committee of the University Hospital of Palermo(I) on the 3rd October 2007 (ref: 09/07).
Health condition(s) or problem(s) studied	Cardiovascular and metabolic diseases
Intervention	Participants will receive on two occasions with a random and blind order respectively a cup of caffeinated coffee and a cup of decaffeinated coffee (a standardised cup of 25 ml Italian expresso) with a one week interval. The two beverages are obtained by the same mixture of coffee and they differ only for their caffeine content.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Caffeine
Primary outcome measure(s)	Amendment as of 15/05/2008: Please note that the primary outcome measure was assessed in only 20 participants. Acute effects of both coffees (caffeinated and decaffeinated) on endothelial function, measured as "Flow Mediated Dilation", and on glucose metabolism, as blood concentrations of glucose, insulin and c-peptide, will be measured in each occasion before, 30 and 60 minutes after coffee ingestion.
Key secondary outcome measure(s)	Amendment as of 15/05/2008: Please note that all secondary outcome measures were assessed in only 20 participants, except the QTc interval measurement (no. 3 below), which was carried out for all participants. 1. Intra-renal haemodynamic measurements (resistance and pulsatility indexes), obtained before and 60 minutes after coffee ingestion in both occasions 2. Blood pressure, obtained before and 60 minutes after coffee ingestion in both occasions 3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion in both occasions 4. A blood sample will be collected before and 60 minutes after coffee ingestion in both occasions and the serum samples will be frozen at -80°C for measurement of some cytokines (Interleukin-6 [IL-6], Tumour Necrotising Factor [TNF]-alpha, etc.)
Completion date	15/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Total final enrolment	20
Key inclusion criteria	1. Male and female healthy subjects 2. Range of age: 25 - 50 years 3. Range of Body Mass Index (BMI): 20 - 28 kg/m^2
Key exclusion criteria	1. Any metabolic, cardiovascular or systemic disease 2. Any drug treatment 3. Smoking habits 4. Pregnancy or lactation in the last six months
Date of first enrolment	01/10/2007
Date of final enrolment	15/12/2007

Locations

Countries of recruitment

Italy

Study participating centre

Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche

Palermo
90127
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/05/2010	04/06/2019	Yes	No

Editorial Notes

04/06/2019: Total final enrolment and publication reference were added.