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 |
| Protocol serial number | 01/2008 |
| Sponsor | University of Palermo (Italy) |
| Funders | Ministry of Education and Research (Ministero dell'Università e della Ricerca - MURST) (Italy), Association Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy), The coffee to be tested is offered by A. Morettino s.p.a., Palermo (Italy) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Via del Vespro, 129
Palermo
90127
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, cross-over, single-blind trial. |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Coffee |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Blood pressure, obtained before, 30 and 60 minutes after coffee ingestion |
| Completion date | 15/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
90127
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
