Hypertension in PregnancyHyPregNCT07074548
Effect of Hydroxytyrosol on NLR, MLR, and SOD in Hypertensive Pregnant Women
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 goal of this clinical trial is to evaluate whether hydroxytyrosol supplementation (10 mg/day for 4 weeks) is effective in improving inflammatory and oxidative stress markers in pregnant women diagnosed with hypertensive disorders of pregnancy (including preeclampsia, chronic hypertension, and gestational… Read more about this study
- Who is it for?
- Ages 24 to 45 years, 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
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jul 2025to 30 Sep 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 24 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy with a live intrauterine fetus
- Gestational age over 24 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 Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: The Effect of Hydroxytyrosol on Improving Neutrophil-to-Lymphocyte Ratio, Monocyte-to-Lymphocyte Ratio, and Superoxide Dismutase in Pregnant Women With Hypertension: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether hydroxytyrosol supplementation (10 mg/day for 4 weeks) is effective in improving inflammatory and oxidative stress markers in pregnant women diagnosed with hypertensive disorders of pregnancy (including preeclampsia, chronic hypertension, and gestational hypertension). The main questions it aims to answer are:
- Does hydroxytyrosol supplementation reduce neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR)?
- Does hydroxytyrosol supplementation lower systolic and/or diastolic blood pressure?
- Does hydroxytyrosol supplementation increase superoxide dismutase (SOD) levels?
Read more
Researchers will compare a group receiving hydroxytyrosol supplementation to a standard care control group to see if hydroxytyrosol produces superior anti-inflammatory and antioxidant effects.
Participants will:
- Take hydroxytyrosol 10 mg orally once daily for 4 weeks (intervention group) or receive standard antenatal care without hydroxytyrosol (control group).
- Undergo laboratory testing (NLR, MLR, SOD) before and after the intervention.
- Have their blood pressure monitored regularly throughout the study period.
Read the detailed description
Hypertensive disorders of pregnancy, including preeclampsia, chronic hypertension, and gestational hypertension, are major contributors to maternal and perinatal morbidity and mortality worldwide. Oxidative stress and systemic inflammation play critical roles in the pathophysiology of HDP. Biomarkers such as the neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), and superoxide dismutase (SOD) have been associated with the severity and progression of these conditions.
Hydroxytyrosol, a polyphenol compound found in olives, has demonstrated potent antioxidant and anti-inflammatory properties in both in vitro and in vivo studies. Its potential therapeutic role in cardiovascular and metabolic diseases suggests a possible benefit in hypertensive pregnancies, though clinical evidence in this population remains limited.
This randomized controlled trial aims to evaluate the effectiveness of hydroxytyrosol supplementation (10 mg/day for 4 weeks) in improving markers of systemic inflammation and oxidative stress among pregnant women with HDP. A total of eligible pregnant women diagnosed with preeclampsia, chronic hypertension, or gestational hypertension will be randomly assigned to receive either hydroxytyrosol supplementation in addition to standard antenatal care (intervention group), or standard antenatal care alone (control group).
The primary outcome measures include changes in NLR and MLR after 4 weeks of supplementation. Secondary outcomes include changes in systolic and diastolic blood pressure, NLR and MLR levels, and serum SOD levels. All participants will undergo baseline and post-intervention laboratory testing and blood pressure monitoring.
The results of this study are expected to provide clinical insight into the potential role of hydroxytyrosol as a supportive therapeutic agent in managing hypertensive disorders during pregnancy, potentially improving maternal outcomes through modulation of oxidative stress and inflammatory response.
- 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 once daily for 4 weeks.
HydroxytyrosolDietary supplement
Hydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 10 mg will be administered orally once daily for 4 weeks to assess its effects on blood pressure 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 once daily for 4 weeks, alongside standard antenatal care. The placebo is visually identical to the hydroxytyrosol supplement to maintain masking. Receives: Dietary Supplement: Placebo; Dietary Supplement: Hydroxytyrosol |
| Hydroxytyrosol Group | Active comparator | Participants in this arm will receive hydroxytyrosol 10 mg orally once daily for 4 weeks, alongside standard antenatal care. Receives: Dietary Supplement: Placebo; Dietary Supplement: Hydroxytyrosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neutrophil-to-Lymphocyte Ratio (NLR), MLR (Monocyte-to-Lymphocyte Ratio), and SOD (Superoxide Dismutase level) from Baseline to Week 4
To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in NLR, MLR, SOD levels between the hydroxytyrosol and placebo groups after 4 weeks.
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 posted20 Jul 2025
- Study start10 Jul 2025
- Primary completion31 Aug 2025
- Study completion30 Sep 2025
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
- 42 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
- NCT07074548
- Sponsor's protocol ID
- 25-03-0308
- Acronym
- HyPreg
- Status last verified
- Dec 2025
- First submitted
- 10 Jul 2025
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydroxytyrosol on Improving Neutrophil-to-Lymphocyte Ratio, Monocyte-to-Lymphocyte Ratio, and Superoxide Dismutase in Pregnant Women With Hypertension: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07074548
- Acronym / sponsor ID
- HyPreg / 25-03-0308
- Conditions
- Hypertension in Pregnancy
- Keywords
- hydroxytyrosol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 20 Jul 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 goal of this clinical trial is to evaluate whether hydroxytyrosol supplementation (10 mg/day for 4 weeks) is effective in improving inflammatory and oxidative stress markers in pregnant women diagnosed with hypertensive disorders of pregnancy (including preeclampsia, chronic hypertension, and gestational hypertension). The main questions it aims to answer are:
- Does hydroxytyrosol supplementation reduce neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR)?
- Does hydroxytyrosol supplementation lower systolic and/or diastolic blood pressure?
- Does hydroxytyrosol supplementation increase superoxide dismutase (SOD) levels?
Researchers will compare a group receiving hydroxytyrosol supplementation to a standard care control group to see if hydroxytyrosol produces superior anti-inflammatory and antioxidant effects.
Participants will:
- Take hydroxytyrosol 10 mg orally once daily for 4 weeks (intervention group) or receive standard antenatal care without hydroxytyrosol (control group).
- Undergo laboratory testing (NLR, MLR, SOD) before and after the intervention.
- Have their blood pressure monitored regularly throughout the study period.
Detailed description
Hypertensive disorders of pregnancy, including preeclampsia, chronic hypertension, and gestational hypertension, are major contributors to maternal and perinatal morbidity and mortality worldwide. Oxidative stress and systemic inflammation play critical roles in the pathophysiology of HDP. Biomarkers such as the neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), and superoxide dismutase (SOD) have been associated with the severity and progression of these conditions.
Hydroxytyrosol, a polyphenol compound found in olives, has demonstrated potent antioxidant and anti-inflammatory properties in both in vitro and in vivo studies. Its potential therapeutic role in cardiovascular and metabolic diseases suggests a possible benefit in hypertensive pregnancies, though clinical evidence in this population remains limited.
This randomized controlled trial aims to evaluate the effectiveness of hydroxytyrosol supplementation (10 mg/day for 4 weeks) in improving markers of systemic inflammation and oxidative stress among pregnant women with HDP. A total of eligible pregnant women diagnosed with preeclampsia, chronic hypertension, or gestational hypertension will be randomly assigned to receive either hydroxytyrosol supplementation in addition to standard antenatal care (intervention group), or standard antenatal care alone (control group).
The primary outcome measures include changes in NLR and MLR after 4 weeks of supplementation. Secondary outcomes include changes in systolic and diastolic blood pressure, NLR and MLR levels, and serum SOD levels. All participants will undergo baseline and post-intervention laboratory testing and blood pressure monitoring.
The results of this study are expected to provide clinical insight into the potential role of hydroxytyrosol as a supportive therapeutic agent in managing hypertensive disorders during pregnancy, potentially improving maternal outcomes through modulation of oxidative stress and inflammatory response.
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: Placebo, Dietary Supplement: HydroxytyrosolParticipants in this arm will receive a placebo capsule orally once 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: Placebo, Dietary Supplement: HydroxytyrosolParticipants in this arm will receive hydroxytyrosol 10 mg orally once daily for 4 weeks, alongside standard antenatal care. |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Singleton pregnancy with a live intrauterine fetus
- Gestational age over 24 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 once daily for 4 weeks. | Dietary supplement | Hydroxytyrosol Group, Placebo Group |
| HydroxytyrosolHydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 10 mg will be administered orally once daily for 4 weeks to assess its effects on blood pressure and inflammatory biomarkers in hypertensive pregnant women. | Dietary supplement | Hydroxytyrosol Group, Placebo Group |
Primary outcome
Change in Neutrophil-to-Lymphocyte Ratio (NLR), MLR (Monocyte-to-Lymphocyte Ratio), and SOD (Superoxide Dismutase level) 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 NLR, MLR, SOD levels between the hydroxytyrosol and placebo groups after 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 2 Jan 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 2 Jan 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 Neutrophil-to-Lymphocyte Ratio (NLR), MLR (Monocyte-to-Lymphocyte Ratio), and SOD (Superoxide Dismutase level) from Baseline to Week 4 (time frame: Baseline and Week 4). 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 2 Jan 2026.