Effect of a Specific Phenolic Compound on Blood Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To evaluate the effects on diastolic BP. To study the phenolic compound bioavailability and to analyze its metabolites for determine the phenolic compound consumption biomarkers. To evaluate the effects on endothelial function by ischemic reactive hyperemia (IRH). 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.

Official Title
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Randomized, Cross-over, Double Blinded, Placebo-controlled Study for the Evaluation of the Postprandial Effect of a Specific PHENOLic Compound on Blood PRESSure

Conditions
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Cardiovascular Risk Factors, Blood Pressure

Intervention / Treatment
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* Dietary Supplement: placebo
* Dietary Supplement: phenolic compound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults men or women (>18 years old) Blood pressure (with no drug intervention) ≥130 mm Hg systolic blood pressure ≤ 159 mmHg No evidence of chronic disease Written informed consent provided before the initial screening visit. Exclusion Criteria: Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥100 mm Hg or taking antihypertensive medication Body mass index (BMI) ≥ 35 kg/m2 Glucose (fasting state) >125 mg/dL LDL-cholesterol >189 mg/dL Triglycerides >350 mg/dL Pregnant or intending to become pregnant Use of medication, antioxidant, or multi-vitamin supplements Chronic alcoholism Intense physical activity (5h/week) Intestinal disorders Following of a vegetarian diet Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women) Being intolerant or suffer from allergy to any of the products of the high fat meal (white bread, olive oil, boiled egg, cheese) or to the products of the study. Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study. Failure to follow the study guidelines.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>control group | Dietary Supplement: placebo<br>* 1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit<br>|
| Experimental: Phenolic compound<br>treated group | Dietary Supplement: phenolic compound<br>* 1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular diseases, endothelial function, systolic blood pressure, metabolomics, cardiovascular risk factor, bioavailability, phenolic compounds, hypertension