Microencapsulated Pomegranate Juice as Anti-Hypertensive

NCT07017296 | Completed DMC

• 1 other identifier: UAEH-ICSA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Trial

Keywords

hypertensive; microencapsulated pomegranate juice; fresh pomegranate juice

Outcome Measures

Primary Outcomes (4)

• Baseline characteristics of the participants, overall and by study group

  age in years

  data collection at the beginning of the study, 10 days

• Baseline characteristics of the participants, overall and by study group

  weight in kilograms

  data collection at the beginning of the study, 10 days

• Baseline characteristics of the participants, overall and by study group

  Height in meters

  data collection at the beginning of the study, 10 days

• Baseline characteristics of the participants, overall and by study group

  systolic and diastolic arterial pressure in mmHg

  data collection at the beginning of the study, 10 days

Secondary Outcomes (5)

• Changes in systolic and diastolic blood pressure at different postprandial periods

  4 weeks

• Changes in systolic and diastolic blood pressure at different postprandial periods

  4 weeks

• Changes in systolic and diastolic blood pressure at different postprandial periods

  4 weeks

• Changes in systolic and diastolic blood pressure at different postprandial periods

  4 weeks

• Changes in systolic and diastolic blood pressure at different postprandial periods

  4 weeks

Study Arms (4)

Water

PLACEBO COMPARATOR

Water as placebo

Other: Placebo

Positive control

ACTIVE COMPARATOR

normal anti-hypertensive medication

Drug: Positive control

Microencapsulated pomegranate juice

EXPERIMENTAL

treated with Microencapsulated pomegranate juice

Dietary Supplement: Active comparator

Fresh pomegranate juice

EXPERIMENTAL

treated with fresh pomegranate juice

Dietary Supplement: Control

Interventions

Placebo OTHER

150 mL of water during the breakfast

Water

Positive control DRUG

Normal antihypertensive in 150 ml of water during the breakfast

Also known as: medication

Positive control

Active comparator DIETARY_SUPPLEMENT

20 g microencapsulated pomegranate juice in 150 mL water

Microencapsulated pomegranate juice

Control DIETARY_SUPPLEMENT

150 mL fresh pomegranate juice

Fresh pomegranate juice

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Autónoma del Estado de Hidalgo: lead
• Instituto Nacional de Cardiologia Ignacio Chavez: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Gabriel Betanzos-Cabrera

Pachuca, Hidalgo, 42082, Mexico

Location

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher-Professor

Model Details: A group of twenty adult women from the "Ejido de Paraiso" health center, Sanitary Jurisdiction 2 Tulancingo de Bravo, Hidalgo Mexico,

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 12, 2025
• Study Start: August 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: May 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

ME (1)