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

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).