Effect of Extra Virgin Olive Oil on Women at Risk for Preeclampsia
Effect of Extra Virgin Olive Oil Addition in the Diet of Women with Higher Risk for Preeclampsia - Interventional Pilot Study
This study is testing whether drinking extra virgin olive oil every day can help high-risk pregnant women lower their chances of developing preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Barzilai Medical Center Academic / other |
| Locations | 1 site (Ashkelon, Ashkelon District) |
| Trial ID | NCT06759545 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential benefits of Extra Virgin Olive Oil from early harvested olives in reducing the risk of preeclampsia among high-risk pregnant women. The intervention involves a daily intake of 42 ml of this olive oil, which is rich in antioxidants and may improve vascular health and reduce oxidative stress. The primary objective is to evaluate the incidence of preeclampsia and its related markers during pregnancy in a randomized, parallel-assignment dietary trial involving 156 participants aged 18 to 45. The study aims to assess the impact of this dietary intervention on pregnancy outcomes, including gestational diabetes mellitus.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 45 with clinical risk factors for preeclampsia, such as previous preeclampsia, chronic hypertension, or obesity.
Not a fit: Patients who do not have clinical risk factors for preeclampsia or those who refuse participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower the risk of preeclampsia and improve pregnancy outcomes for high-risk women.
How similar studies have performed: While dietary interventions for preeclampsia risk are being explored, this specific approach using Extra Virgin Olive Oil is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ashkelon, Ashkelon District
- Barzilai University Medical Center — Ashkelon, Ashkelon District, Israel (Recruiting)
Study contacts
- Study coordinator: Yaniv Dr Yaniv S. Ovadia, RD PhD
- Email: yaniv.ovadia@mail.huji.ac.il
- Phone: + 972 8 6745220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.