Dose dependent acute effects of decaffeinated coffee on endothelial function and glucose metabolism in healthy volunteers
| ISRCTN | ISRCTN41583899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41583899 |
| Secondary identifying numbers | 01/2008 |
- Submission date
- 09/05/2008
- Registration date
- 22/05/2008
- Last edited
- 05/01/2010
- 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
Dr Silvio Buscemi
Scientific
Scientific
Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Via del Vespro, 129
Palermo
90127
Italy
Study information
| Study design | Randomised, cross-over, single-blind trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Local Ethics Committee of the University Hospital of Palermo (I). Date of approval: 06/02/2008 (ref: 02/08) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Coffee |
| Primary outcome measure | 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 study start date | 01/04/2008 |
| Completion date | 15/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| 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 | 01/04/2008 |
| Date of final enrolment | 15/06/2008 |
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
Ministry of Education and Research (Ministero dell'Università e della Ricerca - MURST) (Italy)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Министерство образования и науки, Ministry of Education and Research, HM
- Location
- Estonia
Association Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)
No information available
The coffee to be tested is offered by A. 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 | 01/10/2009 | Yes | No |
