Hypertension in Pregnancy
Conditions
Keywords
hydroxytyrosol
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks.
DIETARY_SUPPLEMENTHydroxytyrosol
Hydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 5 mg will be administered orally twice daily for 4 weeks to assess its effects on blood vessels and inflammatory biomarkers in hypertensive pregnant women.
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study uses identical capsules for hydroxytyrosol and placebo to maintain masking of all parties.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in superoxide dismutase (SOD) levels measured by colorimetric assay from baseline to week 4. | Baseline and 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. |
| Change in Pulsatility Index (PI) of the uterine artery Doppler from baseline to week 4. | Baseline and 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. |
| Change in Resistance Index (RI) of the uterine artery Doppler from baseline to week 4. | Baseline and 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. |
| Change in flow-mediated dilation (FMD) of brachial artery measured by an ultrasound from baseline to week 4. | Baseline and 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. |
Countries
Indonesia
Outcome results
None listed