Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01/2008
Study information
Scientific title
Acronym
Study hypothesis
In a previous study (ISRCTN85096812 - http://www.controlled-trials.com/ISRCTN85096812) endothelial function and glucose metabolism improved after the ingestion of decaffeinated coffee therefore suggesting that non-caffeine components of coffee have beneficial effects. The hypothesis of this study is that these non-caffeine components of coffee might have dose dependent favourable effects on endothelial function and possibly on glucose metabolism.
Ethics approval
Local Ethics Committee of the University Hospital of Palermo (I). Date of approval: 06/02/2008 (ref: 02/08)
Study design
Randomised, cross-over, single-blind trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular and metabolic diseases/ clinical nutrition
Intervention
This is a cross-over, randomised trial.
Participants will receive, on two occasions in random order, one or two cups of decaffeinated coffee (a standardised cup of 25 ml Italian expresso) at one week interval.
Intervention type
Drug
Phase
Not Specified
Drug names
Coffee
Primary outcome measures
1. Fasting acute effects of the two different doses of coffee on endothelial function, measured as the flow mediated dilation (FMD). FMD measurements (outcome assessors blinded) will be performed before, 30 and 60 minutes after coffee ingestion.
2. Fasting acute effects of the two different doses of coffee on glucose metabolism, evaluated on the basis of blood concentrations of glucose, insulin and c-peptide. These blood measurements will be obtained before and 60 minutes after coffee ingestion.
Secondary outcome measures
1. Blood pressure, obtained before, 30 and 60 minutes after coffee ingestion
2. Heart rate, measured continuously for the entire duration of the test (60 min)
3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion
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 future measurements (Interleukin-6 [IL-6], tumour necrosis factor-alpha [TNF-alpha], etc.)
Overall trial start date
01/04/2008
Overall trial end date
15/06/2008
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
15
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
01/04/2008
Recruitment end date
15/06/2008
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
Ministry of Education and Research (Ministero dell'Università e della Ricerca - MURST) (Italy)
Alternative name(s)
Ministry of Education and Research
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Estonia
Funder name
Association Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The coffee to be tested is offered by A. 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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19550428
Publication citations
-
Results
Buscemi S, Verga S, Batsis JA, Tranchina MR, Belmonte S, Mattina A, Re A, Rizzo R, Cerasola G, Dose-dependent effects of decaffeinated coffee on endothelial function in healthy subjects., Eur J Clin Nutr, 2009, 63, 10, 1200-1205, doi: 10.1038/ejcn.2009.51.