NCT07074548

Effect of Hydroxytyrosol on NLR, MLR, and SOD in Hypertensive Pregnant Women

The Effect of Hydroxytyrosol on Improving Neutrophil-to-Lymphocyte Ratio, Monocyte-to-Lymphocyte Ratio, and Superoxide Dismutase in Pregnant Women With Hypertension: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: Female
• Age: 24 Years – 45 Years
• Healthy volunteers: Not accepted

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: 1. Does hydroxytyrosol supplementation reduce neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR)? 2. Does hydroxytyrosol supplementation lower systolic and/or diastolic blood pressure? 3. Does hydroxytyrosol supplementation increase superoxide dismutase (SOD) levels? Researchers will compare a group receiving hydroxytyrosol supplementation to a standard care control group to see if hydroxytyrosol produces superior anti-inflammatory and antioxidant effects. Participants will: * 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.

Detailed description

Hypertensive disorders of pregnancy, including preeclampsia, chronic hypertension, and gestational hypertension, are major contributors to maternal and perinatal morbidity and mortality worldwide. Oxidative stress and systemic inflammation play critical roles in the pathophysiology of HDP. Biomarkers such as the neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), and superoxide dismutase (SOD) have been associated with the severity and progression of these conditions. Hydroxytyrosol, a polyphenol compound found in olives, has demonstrated potent antioxidant and anti-inflammatory properties in both in vitro and in vivo studies. Its potential therapeutic role in cardiovascular and metabolic diseases suggests a possible benefit in hypertensive pregnancies, though clinical evidence in this population remains limited. This randomized controlled trial aims to evaluate the effectiveness of hydroxytyrosol supplementation (10 mg/day for 4 weeks) in improving markers of systemic inflammation and oxidative stress among pregnant women with HDP. A total of eligible pregnant women diagnosed with preeclampsia, chronic hypertension, or gestational hypertension will be randomly assigned to receive either hydroxytyrosol supplementation in addition to standard antenatal care (intervention group), or standard antenatal care alone (control group). The primary outcome measures include changes in NLR and MLR after 4 weeks of supplementation. Secondary outcomes include changes in systolic and diastolic blood pressure, NLR and MLR levels, and serum SOD levels. All participants will undergo baseline and post-intervention laboratory testing and blood pressure monitoring. The results of this study are expected to provide clinical insight into the potential role of hydroxytyrosol as a supportive therapeutic agent in managing hypertensive disorders during pregnancy, potentially improving maternal outcomes through modulation of oxidative stress and inflammatory response.

Conditions

• Hypertension in Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered once daily for 4 weeks.
DIETARY_SUPPLEMENT	Hydroxytyrosol	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.

Timeline

• Start date: 2025-07-10
• Primary completion: 2025-08-31
• Completion: 2025-09-30
• First posted: 2025-07-20
• Last updated: 2026-01-02

Locations

1 site across 1 country: Indonesia