Acute effects of coffee on endothelial function and glucose metabolism in healthy volunteers
| ISRCTN | ISRCTN85096812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85096812 |
| Secondary identifying numbers | 02/2007 |
- 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
Scientific
Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Via del Vespro, 129
Palermo
90127
Italy
Study information
| Study design | Randomised, crossed, double-blind, placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Caffeine |
| Primary outcome measure | 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 study start date | 01/10/2007 |
| Completion date | 15/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
90127
Italy
Sponsor information
University of Palermo (Italy)
University/education
University/education
Piazza Marina
Palermo
90100
Italy
| Website | http://www.unipa.it |
|---|---|
"ROR" |
https://ror.org/044k9ta02 |
Funders
Funder type
Government
Italian Ministry of the University of Scientific and Technological Research (Ministero Dell'università E Della Ricerca Scientifica E Tectnologica [MURST]) (Italy)
No information available
Coffee to be tested is offered by Morettino s.p.a. Palermo (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
