Microencapsulated Pomegranate Juice as Anti-Hypertensive

NCT ID: NCT07017296

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-05-01

Brief Summary

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.

Detailed Description

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).

Conditions

Clinical Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Water

Water as placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

150 mL of water during the breakfast

Positive control

normal anti-hypertensive medication

Group Type: ACTIVE_COMPARATOR

Positive control

Intervention Type: DRUG

Normal antihypertensive in 150 ml of water during the breakfast

Microencapsulated pomegranate juice

treated with Microencapsulated pomegranate juice

Group Type: EXPERIMENTAL

Active comparator

Intervention Type: DIETARY_SUPPLEMENT

20 g microencapsulated pomegranate juice in 150 mL water

Fresh pomegranate juice

treated with fresh pomegranate juice

Group Type: EXPERIMENTAL

Control

Intervention Type: DIETARY_SUPPLEMENT

150 mL fresh pomegranate juice

Interventions

Placebo

150 mL of water during the breakfast

Intervention Type: OTHER

Positive control

Normal antihypertensive in 150 ml of water during the breakfast

Intervention Type: DRUG

Active comparator

20 g microencapsulated pomegranate juice in 150 mL water

Intervention Type: DIETARY_SUPPLEMENT

Control

150 mL fresh pomegranate juice

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

medication

Eligibility Criteria

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role: collaborator

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role: collaborator

Universidad Autónoma del Estado de Hidalgo

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Betanzos-Cabrera PhD

Researcher-Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriel Betanzos-Cabrera

Pachuca, Hidalgo, Mexico

Countries

Mexico

Other Identifiers

UAEH-ICSA

Identifier Type: -

Identifier Source: org_study_id