Hypertension in PregnancyHYDROXY-2NCT07298759
The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy
A study testing Hydroxytyrosol in people with Hypertension in Pregnancy, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
The purpose of this clinical trial is to evaluate the effect of hydroxytyrosol 10 mg/day administered for 4 weeks in pregnant individuals with hypertension. This study will assess whether hydroxytyrosol increases serum superoxide dismutase levels, reduces uterine artery Doppler pulsatility and resistance indices, and… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Hydroxytyrosol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Jun 2025to 27 Feb 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancy with a live intrauterine fetus
- Gestational age 24-32 weeks. Gestational age is confirmed based on:
- Last Menstrual Period (LMP)
- First trimester ultrasound biometry
- Belongs to the Hypertensive Disorders of Pregnancy group, with the following criteria:
- Gestational hypertension and preeclampsia according to ACOG 2018 criteria
- Chronic hypertension according to ACOG 2019 criteria
- Superimposed preeclampsia according to ACOG 2018 criteria
Who cannot join
- Pregnancy with infection, including chronic infections such as tuberculosis (TB), HIV, or hepatitis B
- Pregnancy with other complications (e.g., diabetes mellitus, heart disease, kidney disease, liver disease, malignancy, autoimmune disorders)
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo National Central Public Hospital
Jakarta, Jakarta Special Capital Region, 10430
About this study
Official title: The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial
The purpose of this clinical trial is to evaluate the effect of hydroxytyrosol 10 mg/day administered for 4 weeks in pregnant individuals with hypertension. This study will assess whether hydroxytyrosol increases serum superoxide dismutase levels, reduces uterine artery Doppler pulsatility and resistance indices, and improves brachial artery flow-mediated dilation.
Participants will be randomly assigned to receive either hydroxytyrosol or a matching placebo. Both products will be visually identical to ensure blinding. Participants will take two capsules daily for 4 weeks and attend two study visits for assessments and follow-up.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Placebo, Hydroxytyrosol
- Keywords
- hydroxytyrosol
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks.
HydroxytyrosolDietary supplement
Hydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 5 mg will be administered orally twice daily for 4 weeks to assess its effects on blood vessels and inflammatory biomarkers in hypertensive pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Participants in this arm will receive a placebo capsule orally twice daily for 4 weeks, alongside standard antenatal care. The placebo is visually identical to the hydroxytyrosol supplement to maintain masking. Receives: Dietary Supplement: Placebo |
| Hydroxytyrosol Group | Active comparator | Participants in this arm will receive hydroxytyrosol 5 mg orally twice daily for 4 weeks, alongside standard antenatal care. Receives: Dietary Supplement: Hydroxytyrosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in superoxide dismutase (SOD) levels measured by colorimetric assay from baseline to week 4.
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in superoxide dismutase (SOD) between the hydroxytyrosol and placebo groups after 4 weeks.
This examination utilizes blood serum as the test specimen. The reagent kit employed is the Superoxide Dismutase (SOD) Colorimetric Assay Kit (Zellbio GmbH, Germany; Cat: ZX-44108-192, Lot: ZX25003G). Measurements are conducted using a Biorad model 680 Microplate Reader (Bio-rad Laboratories Inc., CA, USA), integrated with Microplate Manager software version 5.2.1 (Bio-rad Laboratories Inc., CA, USA). The sensitivity of the device utilized in this study is 0.044 U/mL.
Measured: Baseline and Week 4
Change in Pulsatility Index (PI) of the uterine artery Doppler from baseline to week 4.
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Pulsatility Index (PI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks.
All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to obtain the uterine artery flow velocity waveforms. The insonation angle is maintained near 0 degree (<30 degrees), ensuring the peak systolic velocity are greater than 60 cm/second.
Measured: Baseline and Week 4
Change in Resistance Index (RI) of the uterine artery Doppler from baseline to week 4.
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Resistance Index (RI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks.
All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to obtain the uterine artery flow velocity waveforms. The insonation angle is maintained near 0 degree (<30 degrees), ensuring the peak systolic velocity are greater than 60 cm/second.
Measured: Baseline and Week 4
Change in flow-mediated dilation (FMD) of brachial artery measured by an ultrasound from baseline to week 4.
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in flow-mediated dilation (FMD) of brachial artery between the hydroxytyrosol and placebo groups after 4 weeks.
All FMD of brachial artery examinations are using a GE Voluson P6 ultrasound machine equipped with a 5-13 MHz transducer, and performed by a single operator.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start11 Jun 2025
- Primary completion31 Dec 2025
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damar Prasmusinto, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298759
- Sponsor's protocol ID
- 25-03-0305
- Other IDs
- Cipto Mangunkusumo Hospital
- Acronym
- HYDROXY-2
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07298759
- Acronym / sponsor ID
- HYDROXY-2 / 25-03-0305
- Conditions
- Hypertension in Pregnancy
- Keywords
- hydroxytyrosol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 23 Dec 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.
The purpose of this clinical trial is to evaluate the effect of hydroxytyrosol 10 mg/day administered for 4 weeks in pregnant individuals with hypertension. This study will assess whether hydroxytyrosol increases serum superoxide dismutase levels, reduces uterine artery Doppler pulsatility and resistance indices, and improves brachial artery flow-mediated dilation.
Participants will be randomly assigned to receive either hydroxytyrosol or a matching placebo. Both products will be visually identical to ensure blinding. Participants will take two capsules daily for 4 weeks and attend two study visits for assessments and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive a placebo capsule orally twice daily for 4 weeks, alongside standard antenatal care. The placebo is visually identical to the hydroxytyrosol supplement to maintain masking. |
| Hydroxytyrosol Group | Active comparator | Dietary Supplement: HydroxytyrosolParticipants in this arm will receive hydroxytyrosol 5 mg orally twice daily for 4 weeks, alongside standard antenatal care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Singleton pregnancy with a live intrauterine fetus
- Gestational age 24-32 weeks. Gestational age is confirmed based on:
- Belongs to the Hypertensive Disorders of Pregnancy group, with the following criteria:
Key exclusion criteria (3 listed)
- Pregnancy with infection, including chronic infections such as tuberculosis (TB), HIV, or hepatitis B
- Pregnancy with other complications (e.g., diabetes mellitus, heart disease, kidney disease, liver disease, malignancy, autoimmune disorders)
- Refusal to participate in the study
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 |
|---|---|---|
| PlaceboPlacebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks. | Dietary supplement | Placebo Group |
| HydroxytyrosolHydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 5 mg will be administered orally twice daily for 4 weeks to assess its effects on blood vessels and inflammatory biomarkers in hypertensive pregnant women. | Dietary supplement | Hydroxytyrosol Group |
Primary outcome
Change in superoxide dismutase (SOD) levels measured by colorimetric assay from baseline to week 4.
Time frame: Baseline and Week 4
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in superoxide dismutase (SOD) between the hydroxytyrosol and placebo groups after 4 weeks. This examination utilizes blood serum as the test specimen. The reagent kit employed is the Superoxide Dismutase (SOD) Colorimetric Assay Kit (Zellbio GmbH, Germany; Cat: ZX-44108-192, Lot: ZX25003G). Measurements are conducted using a Biorad model 680 Microplate Reader (Bio-rad Laboratories Inc., CA, USA), integrated with Microplate Manager software version 5.2.1 (Bio-rad Laboratories Inc., CA, USA). The sensitivity of the device utilized in this study is 0.044 U/mL.
Change in Pulsatility Index (PI) of the uterine artery Doppler from baseline to week 4.
Time frame: Baseline and Week 4
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Pulsatility Index (PI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks. All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to obtain the uterine artery flow velocity waveforms. The insonation angle is maintained near 0 degree (<30 degrees), ensuring the peak systolic velocity are greater than 60 cm/second.
Change in Resistance Index (RI) of the uterine artery Doppler from baseline to week 4.
Time frame: Baseline and Week 4
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Resistance Index (RI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks. All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to obtain the uterine artery flow velocity waveforms. The insonation angle is maintained near 0 degree (<30 degrees), ensuring the peak systolic velocity are greater than 60 cm/second.
Change in flow-mediated dilation (FMD) of brachial artery measured by an ultrasound from baseline to week 4.
Time frame: Baseline and Week 4
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in flow-mediated dilation (FMD) of brachial artery between the hydroxytyrosol and placebo groups after 4 weeks. All FMD of brachial artery examinations are using a GE Voluson P6 ultrasound machine equipped with a 5-13 MHz transducer, and performed by a single operator.
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 26 Aug 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 Hydroxytyrosol in people with Hypertension in Pregnancy, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
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 8 inclusion and 3 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 26 Aug 2026. 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 Indonesia. 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?
Change in superoxide dismutase (SOD) levels measured by colorimetric assay from baseline to week 4. (time frame: Baseline and Week 4). 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?
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 26 Aug 2026.