Condition: Preeclampsia (PE) Risk · Sponsor: Yaniv Ovadia
This study explores the potential benefits of Extra Virgin Olive Oil from early harvested olives (EVOOEH) in reducing the risk of preeclampsia (PE) in high-risk pregnant women. EVOO, particularly EVOOEH, is rich in antioxidant compounds, including polyphenols, which may help improve vascular health and reduce oxidative stress, potentially preventing complications like PE. The hypothesis is that EVOOEH may reduce microvascular damage, improve placentation, and prevent dysglycemia, ultimately lowering the risk of PE and gestational diabetes mellitus (GDM). The primary objective of this intervention is to evaluate the effect of EVOOEH on PE incidence during pregnancy, specifically assessing the impact on markers of PE, GDM, and other pregnancy-related outcomes. The study is designed as an interventional, randomized, parallel-assignment dietary trial involving 156 pregnant women at high risk for PE, aged 18 to 45. Participants will receive either a daily dose of 42 ml (three tablespoons) of EVOOEH or the Ministry of Health (MOH) general dietary recommendations for pregnancy for four weeks, starting between 8 to 16 weeks of gestation. The study arms are as follows: EVOOEH arm: Participants will consume 42 ml of EVOOEH daily along with MOH dietary recommendations for four weeks (n=78). Control arm: Participants will follow only the MOH dietary recommendations for four weeks (n=78). The intervention will occur alongside low-dose aspirin prophylaxis for PE prevention, as recomme…
This description comes directly from the study's public registry record.
Yaniv Dr Yaniv S. Ovadia, RD PhD · + 972 8 6745220 · yaniv.ovadia@mail.huji.ac.il
Arie Dr Arie Budovsky, PhD · + 972 8 6746146 · arieb@bmc.gov.il
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| Barzilai University Medical Center | Ashkelon, Ashkelon District, Israel | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06759545