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Search / Trial NCT06759545

An Interventional Pilot Study on the Effect of Extra Virgin Olive Oil on Women with Preeclampsia Risk

Launched by YANIV OVADIA · Dec 29, 2024

Trial Information

Current as of July 16, 2025

Recruiting

Keywords

Extra Virgin Olive Oil From Early Harvested Olives Preeclampsia Fms Like Tyrosine Kinase 1 Plasma Hydroxytyrosol Dietary Intervention Point Mediterranean Diet Adherence Screener Prevention

ClinConnect Summary

This clinical trial is studying whether Extra Virgin Olive Oil from early harvested olives can help reduce the risk of preeclampsia (PE) in pregnant women who are at high risk for this condition. Preeclampsia is a serious pregnancy complication that can affect both the mother and baby. The researchers believe that the antioxidants in this specific type of olive oil might improve blood vessel health and lower the chances of developing PE and gestational diabetes. The study will involve 156 women aged 18 to 45 who have risk factors for PE, such as a history of the condition, obesity, or diabetes, and are between 8 to 16 weeks pregnant.

Participants will be randomly assigned to one of two groups: one group will take a daily dose of Extra Virgin Olive Oil along with general dietary advice for four weeks, while the other group will only follow the dietary advice. Throughout the study, the women will be monitored for changes in health markers related to preeclampsia and gestational diabetes, and their adherence to a healthy diet will be tracked. This trial aims to better understand if this dietary change can help improve pregnancy outcomes for women at higher risk of complications.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Pregnant women with clinical risk factors for PE \[previous PE, primigravida, chronic hypertension, chronic renal disease, autoimmune disease (systemic lupus erythematosus, antiphospholipid antibody syndrome), overweight (BMI\>30), obesity (BMI\>35), morbid obesity (BMI\>40), presentational diabetes (type 1 or type 2), multiple pregnancy\].
  • gestational ages of 8 to 16 weeks attending Barzilai University Medical Center at Ashkelon (BUMCA).
  • Exclusion Criteria:
  • • Refusing enrollment or participation.

About Yaniv Ovadia

Yaniv Ovadia is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on ethical practices and patient safety, the organization collaborates with leading researchers and institutions to design and implement clinical trials that address critical health challenges. Yaniv Ovadia emphasizes rigorous scientific methodology and compliance with regulatory standards, ensuring that each study contributes valuable insights to the medical community. Through its initiatives, the sponsor aims to foster the development of new therapies and improve patient outcomes across various therapeutic areas.

Locations

Ashkelon, Ashkelon District, Israel

Patients applied

0 patients applied

Trial Officials

Dr Yaniv S. Ovadia, RD PhD

Study Director

Barzilai University Medical Center Ashkelon

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported