Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/10/2007
Date assigned
06/11/2007
Last edited
15/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Silvio Buscemi

ORCID ID

Contact details

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

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

http://www.unipa.it

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

Publication citations

Additional files

Editorial Notes