Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02/2007
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the Local Ethical Committee of the University Hospital of Palermo(I) on the 3rd October 2007 (ref: 09/07).
Study design
Randomised, crossed, double-blind, placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Caffeine
Primary outcome measures
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.
Secondary outcome measures
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.)
Overall trial start date
01/10/2007
Overall trial end date
15/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/10/2007
Recruitment end date
15/12/2007
Locations
Countries of recruitment
Italy
Trial participating centre
Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Palermo
90127
Italy
Sponsor information
Organisation
University of Palermo (Italy)
Sponsor details
Piazza Marina
Palermo
90100
Italy
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Italian Ministry of the University of Scientific and Technological Research (Ministero Dell'università E Della Ricerca Scientifica E Tectnologica [MURST]) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Coffee to be tested is offered by Morettino s.p.a. Palermo (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary