NCT07074548

Brief 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 hypertension). The main questions it aims to answer are:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

July 10, 2025

Last Update Submit

December 29, 2025

Conditions

Hypertension in Pregnancy

Keywords

hydroxytyrosol

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and Week 4

Study Arms (2)

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.

Dietary Supplement: PlaceboDietary 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.

Dietary Supplement: PlaceboDietary Supplement: Hydroxytyrosol

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered once daily for 4 weeks.

Hydroxytyrosol GroupPlacebo Group
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.

Hydroxytyrosol GroupPlacebo Group

Eligibility Criteria

Age24 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Cipto Mangunkusumo National Central Public Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

3,4-dihydroxyphenylethanol

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study uses identical capsules for hydroxytyrosol and placebo to maintain masking of all parties.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Maternal-Fetal Medicine Specialist, ObstetricianGynecologist and Principal Investigator

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

July 10, 2025

Primary Completion

August 31, 2025

Study Completion

September 30, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

ID(1)