Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Rovira i Virgili | OTHER |
| Hospital Universitari Sant Joan de Reus | OTHER |
| Fundació Catalana per a la Recerca i la Innovació (FCRI) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic BP after ingestion of a high fat meal.
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic blood pressure (BP) after ingestion of a high fat meal.
The secondaries objectives are:
The sample size was calculated using a previous studies using systolic blood pressure (SBP) as the primary outcome measure. A total of 14 subjects are needed, assuming variance components of approximately 20.0, to detect differences between treatments (placebo and phenolic product) of 10 mmHg, with a bilateral significance level of α=0.05, a power of 80% and a standard deviation of 11.82 mmHg at the baseline.
To compare the main variable efficiency of the products of study as well as secondary variables of efficiency, will carry out analysis of the covariance (ANCOVA) with basal value as covariable, followed by the Tukey test for determining multiple differences. All tests will be carried out with significance to bilateral level of 5%. It is considered significant value p<0,05. The data will be analyzed using the "SPSS" program version 22.
The statistical analysis will follow the principles specified in the guidelines of the International Conference on Harmonization (ICH) E9 and CPMP/EWP/908/99 ICH E9 Points to Consider on Multiplicity Issues in Clinical Trials.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | control group |
|
| Phenolic compound | Experimental | treated group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Dietary Supplement | 1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Systolic Blood Pressure | During each visit (2 visits in total), systolic BP will be measured after 10 min in a seated position in a comfortable room by the physician. The measurement will be taken in triplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; PEROXFARMA, Barcelona, Spain). The first measurement will be discarded and the final result will be the average of the other measurements.. The research team will mesure the change in the evolution of systolic blood pressure between visits (at least 1 week between visits). | In each visit (2 visits in total), systolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement. |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure | During each visit (2 visits in total), diastolic BP will be measured after 10 min in a seated position in a comfortable room by the physician. The measurement will be taken in triplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; PEROXFARMA, Barcelona, Spain). The first measurement will be discarded and the final result will be the average of the other measurements.. The research team will mesure the change in the evolution of diastolic blood pressure between visits (at least 1 week between visits). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Maria Valls, PhD | Contact | +34977759377/636944723 | estudis@ctns.cat | |
| Anna Pedret, PhD | Contact | +34977759377/636944723 | estudis@ctns.cat |
| Name | Affiliation | Role |
|---|---|---|
| Rosa Solà , PhD | University Rovira i Virgili / Hospital Universitari Sant Joan de Reus | Principal Investigator |
| Begoña Muguerza, PhD | University Rovira i Virgili | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technological Centre of Nutrition and Health (CTNS) | Recruiting | Reus | Tarragona | 43204 | Spain |
Not provided
| Label | URL |
|---|---|
| Technological Centre of Nutrition and Health | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| phenolic compound | Dietary Supplement | 1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit |
|
| In each visit (2 visits in total), diastolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement. |
| Ischemic reactive hyperemia (IRH) | The endothelial-dependent vasomotor functions will be measured as IRH by a Laser-Doppler linear PERIFLUX 5000 flowmeter (PERIMED AB, Stockholm, Sweden) | In each visit (2 visits in total), at 0, 120, 240 and 360 minutes |
| Bioavailability of phenolic compound in plasma samples | The phenolic compound bioavailability will be analysed in all volunteers and according to the technical reference at the time of its determination, as it may be to analyse automatic, ELISA kits, or other techniques. | In each visit (2 visits in total), at 0, 60, 120, 180, 240, 300 and 360 minutes (heparin lithium plasma) |
| Bioavailability of phenolic compound in urine | The phenolic compound bioavailability will be analysed according to the technical reference at the time of its determination, as it may be to analyse automatic, ELISA kits, or other techniques | In each visit (2 visits in total), at 0, 180 and 360 minutes (total urine) |