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 (HYDROXY-2)

Dr Cipto Mangunkusumo General Hospital

Status: Active, not recruiting

Conditions: Hypertension in Pregnancy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Hydroxytyrosol

Study type: Interventional

Funder types: Other

Identifiers

NCT07298759

Cipto Mangunkusumo Hospital (Other Identifier)

25-03-0305

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Singleton pregnancy with a live intrauterine fetus

2. Gestational age 24-32 weeks. Gestational age is confirmed based on:

   • Last Menstrual Period (LMP)
   • First trimester ultrasound biometry

3. 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

Exclusion criteria

1. Pregnancy with infection, including chronic infections such as tuberculosis (TB), HIV, or hepatitis B
2. Pregnancy with other complications (e.g., diabetes mellitus, heart disease, kidney disease, liver disease, malignancy, autoimmune disorders)
3. Refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Hydroxytyrosol Group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Hydroxytyrosol