Clinical TrialNCT07017296
Microencapsulated Pomegranate Juice as Anti-Hypertensive
A study testing Active comparator in people with Clinical Trial, run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Clinical Trial
- What is being tested?
- Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 15 Aug 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The In Vivo Anti-hypertensive Evaluation of Microencapsulated Pomegranate Juice Decreases the Diastolic Pressure in the Postprandial
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.
Read the 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
- Being tested
- Placebo, Positive control, Active comparator, Control
- Keywords
- hypertensive, microencapsulated pomegranate juice, fresh pomegranate juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
150 mL of water during the breakfast
Positive controlDrug
Also called medication
Normal antihypertensive in 150 ml of water during the breakfast
Active comparatorDietary supplement
20 g microencapsulated pomegranate juice in 150 mL water
ControlDietary supplement
150 mL fresh pomegranate juice
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Water as placebo Receives: Other: Placebo |
| Positive control | Active comparator | normal anti-hypertensive medication Receives: Drug: Positive control |
| Microencapsulated pomegranate juice | Experimental | treated with Microencapsulated pomegranate juice Receives: Dietary Supplement: Active comparator |
| Fresh pomegranate juice | Experimental | treated with fresh pomegranate juice Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics of the participants, overall and by study group
age in years
Measured: data collection at the beginning of the study, 10 days
Baseline characteristics of the participants, overall and by study group
weight in kilograms
Measured: data collection at the beginning of the study, 10 days
Baseline characteristics of the participants, overall and by study group
Height in meters
Measured: 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
Measured: data collection at the beginning of the study, 10 days
Secondary outcomes (5)
Changes in systolic and diastolic blood pressure at different postprandial periods
postprandial systolic and diastolic blood pressure in mmHg at time 0
Measured: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
postprandial systolic and diastolic blood pressure in mmHg at 30 min
Measured: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
postprandial systolic and diastolic blood pressure in mmHg at 60 min
Measured: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
postprandial systolic and diastolic blood pressure in mmHg at 90 min
Measured: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
postprandial systolic and diastolic blood pressure in mmHg at 120 min
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 Aug 2024
- Primary completion31 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A group of twenty adult women from the "Ejido de Paraiso" health center, Sanitary Jurisdiction 2 Tulancingo de Bravo, Hidalgo Mexico,
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma del Estado de Hidalgo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez, Universidad Nacional Autonoma de Mexico
- Responsible party
- Principal investigator, Gabriel Betanzos-Cabrera PhD, Universidad Autónoma del Estado de Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017296
- Sponsor's protocol ID
- UAEH-ICSA
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41938572
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The In Vivo Anti-hypertensive Evaluation of Microencapsulated Pomegranate Juice Decreases the Diastolic Pressure in the Postprandial
- ClinicalTrials.gov ID
- NCT07017296
- Acronym / sponsor ID
- UAEH-ICSA
- Conditions
- Clinical Trial
- Keywords
- hypertensive, microencapsulated pomegranate juice, fresh pomegranate juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Autónoma del Estado de HidalgoUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez, Universidad Nacional Autonoma de Mexico
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- A group of twenty adult women from the "Ejido de Paraiso" health center, Sanitary Jurisdiction 2 Tulancingo de Bravo, Hidalgo Mexico,
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: PlaceboWater as placebo |
| Positive control | Active comparator | Drug: Positive controlnormal anti-hypertensive medication |
| Microencapsulated pomegranate juice | Experimental | Dietary Supplement: Active comparatortreated with Microencapsulated pomegranate juice |
| Fresh pomegranate juice | Experimental | Dietary Supplement: Controltreated with fresh pomegranate juice |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo150 mL of water during the breakfast | Other | Water |
| Positive controlAlso: medicationNormal antihypertensive in 150 ml of water during the breakfast | Drug | Positive control |
| Active comparator20 g microencapsulated pomegranate juice in 150 mL water | Dietary supplement | Microencapsulated pomegranate juice |
| Control150 mL fresh pomegranate juice | Dietary supplement | Fresh pomegranate juice |
Primary outcome
Baseline characteristics of the participants, overall and by study group
Time frame: data collection at the beginning of the study, 10 days
age in years
Baseline characteristics of the participants, overall and by study group
Time frame: data collection at the beginning of the study, 10 days
weight in kilograms
Baseline characteristics of the participants, overall and by study group
Time frame: data collection at the beginning of the study, 10 days
Height in meters
Baseline characteristics of the participants, overall and by study group
Time frame: data collection at the beginning of the study, 10 days
systolic and diastolic arterial pressure in mmHg
5 secondary outcomes
Changes in systolic and diastolic blood pressure at different postprandial periods
Time frame: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
Time frame: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
Time frame: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
Time frame: 4 weeks
Changes in systolic and diastolic blood pressure at different postprandial periods
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 41938572Betanzos-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator in people with Clinical Trial, run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristics of the participants, overall and by study group (time frame: data collection at the beginning of the study, 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.