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

NCT07298759 | Active Not Recruiting DMC

• 2 other identifiers: 25-03-0305Cipto Mangunkusumo Hospital
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

hydroxytyrosol

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and Week 4

Study Arms (2)

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.

Dietary Supplement: Placebo

Hydroxytyrosol Group

ACTIVE COMPARATOR

Participants in this arm will receive hydroxytyrosol 10 mg orally twice daily for 4 weeks, alongside standard antenatal care.

Dietary Supplement: Hydroxytyrosol

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo Group

Hydroxytyrosol DIETARY_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 twice daily for 4 weeks to assess its effects on blood vessels and inflammatory biomarkers in hypertensive pregnant women.

Hydroxytyrosol Group

Eligibility Criteria

• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Dr. Cipto Mangunkusumo National Central Public Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

3,4-dihydroxyphenylethanol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular 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, Obstetrician-Gynecologist and Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: December 23, 2025
• Study Start: June 11, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

ID (1)