Clinical trial NCT02628353: Effect of a Specific Phenolic Compound on Blood Pressure
Official title: Randomized, Cross-over, Double Blinded, Placebo-controlled Study for the Evaluation of the Postprandial Effect of a Specific PHENOLic Compound on Blood PRESSure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiovascular Risk Factors
Blood Pressure
Keywords: Cardiovascular diseases
endothelial function
systolic blood pressure
metabolomics
cardiovascular risk factor
bioavailability
phenolic compounds
hypertension
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
Collaborators: name: University Rovira i Virgili
name: Hospital Universitari Sant Joan de Reus
name: Fundació Catalana per a la Recerca i la Innovació (FCRI)
First posted: 2015-12-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Systolic Blood Pressure
timeFrame: 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 outcomes:
measure: Diastolic Blood Pressure
timeFrame: 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.
measure: Ischemic reactive hyperemia (IRH)
timeFrame: In each visit (2 visits in total), at 0, 120, 240 and 360 minutes
measure: Bioavailability of phenolic compound in plasma samples
timeFrame: In each visit (2 visits in total), at 0, 60, 120, 180, 240, 300 and 360 minutes (heparin lithium plasma)
measure: Bioavailability of phenolic compound in urine
timeFrame: In each visit (2 visits in total), at 0, 180 and 360 minutes (total urine)
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Technological Centre of Nutrition and Health (CTNS)
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili / Hospital Universitari Sant Joan de Reus
name: Rosa Solà, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Rovira i Virgili
name: Begoña Muguerza, PhD
role: STUDY_CHAIR
References: