Effect of a Specific Phenolic Compound on Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Olive Polyphenols in Cardiovascular Prevention

NCT04874961

Hypertension, Systolic

COMPLETED PHASE4

Flavonoids, Blood Pressure and Blood Vessel Function

NCT01530893

Cardiovascular Disease Risk Reduction

COMPLETED NA

Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

NCT02572219

Hypertension

COMPLETED PHASE3

Effect of (Poly)Phenolic on Cardiometabolic Risk of Postmenopausal Women

NCT05255367

Post-menopausal Women Overweight and Obesity

COMPLETED NA

Effect of Phenolic Acids on the Human Vasculature

NCT03599128

Endothelial Dysfunction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Risk Factors Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

control group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit

Phenolic compound

treated group

Group Type EXPERIMENTAL

phenolic compound

Intervention Type DIETARY_SUPPLEMENT

1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo

1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit

Intervention Type DIETARY_SUPPLEMENT

phenolic compound

1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes