Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/05/2008
Date assigned
22/05/2008
Last edited
05/01/2010
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

Dr 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

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

http://www.unipa.it/

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

  1. 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.

Additional files

Editorial Notes