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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks.
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.
Dr. Cipto Mangunkusumo National Central Public Hospital
Jakarta, Jakarta Special Capital Region, Indonesia
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 4
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