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| Name | Class |
|---|---|
| Instituto Nacional de Cardiologia Ignacio Chavez | OTHER |
| Universidad Nacional Autonoma de Mexico | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water | Placebo Comparator | Water as placebo |
|
| Positive control | Active Comparator | normal anti-hypertensive medication |
|
| Microencapsulated pomegranate juice | Experimental | treated with Microencapsulated pomegranate juice |
|
| Fresh pomegranate juice | Experimental | treated with fresh pomegranate juice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 150 mL of water during the breakfast |
| |
| Positive control |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in systolic and diastolic blood pressure at different postprandial periods | postprandial systolic and diastolic blood pressure in mmHg at time 0 | 4 weeks |
| Changes in systolic and diastolic blood pressure at different postprandial periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriel Betanzos-Cabrera | Pachuca | Hidalgo | 42082 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41938572 | Derived | Betanzos-Cabrera G, Cabrera-Garcia P, Fabella-Illescas HE, Valle-Mondragon LD, Talamantes-Gomez JM, Sanchez-Ortiz NA, Ariza-Ortega JA, Ojeda-Ramirez D, Ahlgren-Beckendorf JA. Postprandial Antihypertensive Evaluation of Microencapsulated Pomegranate Juice in Women With Mild Hypertension: A Randomized Pilot Study. Int J Hypertens. 2026 Apr 2;2026:7665540. doi: 10.1155/ijhy/7665540. eCollection 2026. |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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A group of twenty adult women from the "Ejido de Paraiso" health center, Sanitary Jurisdiction 2 Tulancingo de Bravo, Hidalgo Mexico,
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| Drug |
Normal antihypertensive in 150 ml of water during the breakfast |
|
|
| Active comparator | Dietary Supplement | 20 g microencapsulated pomegranate juice in 150 mL water |
|
| Control | Dietary Supplement | 150 mL fresh pomegranate juice |
|
postprandial systolic and diastolic blood pressure in mmHg at 30 min
| 4 weeks |
| Changes in systolic and diastolic blood pressure at different postprandial periods | postprandial systolic and diastolic blood pressure in mmHg at 60 min | 4 weeks |
| Changes in systolic and diastolic blood pressure at different postprandial periods | postprandial systolic and diastolic blood pressure in mmHg at 90 min | 4 weeks |
| Changes in systolic and diastolic blood pressure at different postprandial periods | postprandial systolic and diastolic blood pressure in mmHg at 120 min | 4 weeks |