Clinical trial NCT07017296: Microencapsulated Pomegranate Juice as Anti-Hypertensive
Official title: The In Vivo Anti-hypertensive Evaluation of Microencapsulated Pomegranate Juice Decreases the Diastolic Pressure in the Postprandial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trial
Keywords: hypertensive
microencapsulated pomegranate juice
fresh pomegranate juice
Lead sponsor: Universidad Autónoma del Estado de Hidalgo
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Cardiologia Ignacio Chavez
name: Universidad Nacional Autonoma de Mexico
First posted: 2025-06-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A group of twenty adult women from the "Ejido de Paraiso" health center, Sanitary Jurisdiction 2 Tulancingo de Bravo, Hidalgo Mexico,
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Baseline characteristics of the participants, overall and by study group
timeFrame: data collection at the beginning of the study, 10 days
measure: Baseline characteristics of the participants, overall and by study group
timeFrame: data collection at the beginning of the study, 10 days
measure: Baseline characteristics of the participants, overall and by study group
timeFrame: data collection at the beginning of the study, 10 days
measure: Baseline characteristics of the participants, overall and by study group
timeFrame: data collection at the beginning of the study, 10 days
Secondary outcomes:
measure: Changes in systolic and diastolic blood pressure at different postprandial periods
timeFrame: 4 weeks
measure: Changes in systolic and diastolic blood pressure at different postprandial periods
timeFrame: 4 weeks
measure: Changes in systolic and diastolic blood pressure at different postprandial periods
timeFrame: 4 weeks
measure: Changes in systolic and diastolic blood pressure at different postprandial periods
timeFrame: 4 weeks
measure: Changes in systolic and diastolic blood pressure at different postprandial periods
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Pachuca
country: Mexico
facility: Gabriel Betanzos-Cabrera
state: Hidalgo
Study officials:
References: