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Completed

NCT Number: NCT07017296

Microencapsulated Pomegranate Juice as Anti-Hypertensive

Introduction: Hypertension is a significant risk factor for cardiovascular disease (CVD). Pomegranate is a fruit rich in polyphenols that exerts an antihypertensive effect. Objective: The present work evaluated microencapsulated pomegranate juice (MPJ) as an anti-hypertensive in patients with mild hypertension. Materials and Methods: The content of phenols, flavonoids, anthocyanins, and antioxidant activity in fresh pomegranate juice (FPJ) and MPJ was determined. Subsequently, the postprandial anti-hypertensive effect was evaluated in recruited participants who consumed approximately 480 kcal breakfast. Four experimental groups with five participants each were evaluated: FPJ, 150 mL fresh juice; MPJ, 20 g microencapsulated pomegranate juice; the participant's usual drug (AH); and 150 mL water (W) with breakfast. Each participant's blood pressure (BP) was measured before and after breakfast at 30, 60, 90, and 120-min. Changes in BP values were evaluated as a function of time using generalized linear models.

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gabriel Betanzos-Cabrera

Pachuca, Hidalgo, 42082, Mexico

About this study

This study was conducted under the Law of General Health of Mexico, which was based on the 1964 Declaration of Helsinki. After a thorough review, the local Ethics Committee of Ministry of Health of Hidalgo approved the study (register number FSSA2021106). All participants signed a document indicating their informed consent. A group of twenty women from the "Ejido de Paraiso" Health Center, Sanitary Jurisdiction 2 Tulancingo de Bravo, Hidalgo México, were enrolled. Participation was based on the following inclusion criteria: patients fully diagnosed with mild hypertension values ranging from 140-159 mmHg/90-99 mmHg, and participants agreed to withhold anti-hypertensive medication for 48 h before the measurements. Participants' mean age was 56.31 ± 10.8 years. Women were selected for this study to avoid gender-bias which could result from a male and female cohort. In past decades, women have been under-represented in health care studies. Women allergic to the pomegranate fruit or diagnosed with COVID-19 were excluded.

The population was divided into four groups of 5 participants each as follows: 1) W, 150 mL of water; 2) AH, drug in 150 mL of water; 3) FPJ, 150 mL fresh pomegranate juice*; 4) MPJ, 20 g microencapsulated pomegranate juice in 150 mL water*. Asterisk (*) indicates an equivalent to 1.5 mmoles of total polyphenols. Breakfast consisted of two slices of whole wheat bread, two slices of turkey and pork ham, 30 g of panela cheese, one slice of tomato, one teaspoon of mayonnaise, two tablespoons of beans, and one cup of ultra-pasteurized whole milk.

Variables The dependent variable was arterial blood pressure (systolic or diastolic); measurements were taken in duplicate using a calibrated sphygmomanometer at pre-prandially (time 0) and post-prandially at 30, 60, 90, and 120 minutes after the meal. Time intervals were chosen to capture the immediate and short-term effects of the interventions on blood pressure.

The model was adjusted for two variables: Age in years, and Body Mass Index (BMI) in kg/m2. Estimation of BMI was based on Body weight in kilograms (kg) and height in meters (M). To estimate the changes in blood pressure in each period concerning time 0, 4 dummy variables with values of 0 or 1 were considered, for each postprandial period (at 30, 60, 90, and 120 minutes).

Participant data analysis Baseline measurements as mean ± standard deviation; an ANOVA test was used to assess differences between the study groups. Changes in blood pressure were evaluated using a generalized linear model (adjusted for BMI and age). The results of the model (coefficients) show the changes between each time point (30, 60, 90, and 120 minutes) relative to time 0 (baseline period) in mm/Hg. Statistical significance was defined as a p-value <0.05. All analyses were performed with the Statistical Program Package for the Social Sciences (SPSS) version 15 (SPSS, Inc., Chicago, Illinois USA).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients fully diagnosed with mild hypertension values ranging from 140-159 mmHg/90-99 mmHg
  • participants agreed to withhold anti-hypertensive medication for 48 h before the measurements

Exclusion criteria

  • Patients who were taking or were taking any product used as antihypertensive before 48h.
  • Patients who were allergic to pomegranate fruit.
  • Patients who did not attend a consultation at the health center.
  • Patients diagnosed with Coronavirus disease 2019 (COVID-19).

Treatment and study plan

Placebo

Other

150 mL of water during the breakfast

Positive control

Drug

Normal antihypertensive in 150 ml of water during the breakfast

Other names: medication

Active Comparator

Dietary Supplement

20 g microencapsulated pomegranate juice in 150 mL water

Control

Dietary Supplement

150 mL fresh pomegranate juice

Primary outcomes

  1. Baseline characteristics of the participants, overall and by study group

    Time frame: data collection at the beginning of the study, 10 days

    age in years

  2. Baseline characteristics of the participants, overall and by study group

    Time frame: data collection at the beginning of the study, 10 days

    weight in kilograms

  3. Baseline characteristics of the participants, overall and by study group

    Time frame: data collection at the beginning of the study, 10 days

    Height in meters

  4. Baseline characteristics of the participants, overall and by study group

    Time frame: data collection at the beginning of the study, 10 days

    systolic and diastolic arterial pressure in mmHg

Secondary outcomes

  1. Changes in systolic and diastolic blood pressure at different postprandial periods

    Time frame: 4 weeks

    postprandial systolic and diastolic blood pressure in mmHg at time 0

  2. Changes in systolic and diastolic blood pressure at different postprandial periods

    Time frame: 4 weeks

    postprandial systolic and diastolic blood pressure in mmHg at 30 min

  3. Changes in systolic and diastolic blood pressure at different postprandial periods

    Time frame: 4 weeks

    postprandial systolic and diastolic blood pressure in mmHg at 60 min

  4. Changes in systolic and diastolic blood pressure at different postprandial periods

    Time frame: 4 weeks

    postprandial systolic and diastolic blood pressure in mmHg at 90 min

  5. Changes in systolic and diastolic blood pressure at different postprandial periods

    Time frame: 4 weeks

    postprandial systolic and diastolic blood pressure in mmHg at 120 min

Sponsors and collaborators

Lead sponsor

Universidad Autónoma del Estado de Hidalgo

Other

Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez
  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

The In Vivo Anti-hypertensive Evaluation of Microencapsulated Pomegranate Juice Decreases the Diastolic Pressure in the Postprandial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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