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

Effect of Extra Virgin Olive Oil Addition in the Diet of Women with Higher Risk for Preeclampsia - Interventional Pilot Study

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 recommended by guidelines for women at high risk. Key compliance markers include adherence to a Mediterranean diet as measured by the Mediterranean Diet Adherence Screener (MEDASIS) and hydroxytyrosol levels in maternal blood. The study will mask data analysis to minimize bias.

The primary outcome measures are maternal glucose challenge test (GCT) results and the serum soluble FMS-like tyrosine kinase 1/placental growth factor (sFlt-1/PlGF) ratio at the end of the intervention. Secondary outcomes include the incidence of GDM, PE, cesarean sections, preterm delivery, small for gestational age (SGA) births, blood pressure measurements, gestational age at delivery, and any relevant data available from participants' medical records.

Eligibility criteria include pregnant women with risk factors for PE such as a history of PE, chronic hypertension, obesity, or diabetes, among others, and a gestational age between 8 to 16 weeks. Exclusion criteria involve low-risk pregnancies or women who refuse participation.

Blood samples will be collected to assess 25-hydroxyvitamin D (25(OH)D), hydroxytyrosol (HT), and the sFlt-1/PlGF ratio. Laboratory analyses will be conducted at Barzilai University Medical Center and the Weizmann Institute of Science. This study seeks to determine whether EVOOEH's higher polyphenol content compared to standard EVOO can offer additional protective benefits against PE and related complications in high-risk pregnancies.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia (PE) Risk
• Intervention / Treatment: Other: Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEH; Other: Dietary MOH recommendations

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaniv Dr Yaniv S. Ovadia, RD PhD; Phone Number: + 972 8 6745220; Email: yaniv.ovadia@mail.huji.ac.il
• Study Contact Backup: Name: Arie Dr Arie Budovsky, PhD; Phone Number: + 972 8 6746146; Email: arieb@bmc.gov.il

Study Locations

• Israel
  • Ashkelon District
    • Ashkelon, Ashkelon District, Israel, 7830604
      • Recruiting
      • Barzilai University Medical Center
      • Contact: Dr Yaniv Ovadia, RD PhD; Phone Number: + 972 54 8111174; Email: yaniv.ovadia@mail.huji.ac.il
      • Contact: Dr Arie Budovsky, PhD; Email: arieb@bmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EVOOEH arm; Daily addition of 42 ml (three tablespoon) at each morning of EVOOEH to MOH recommendations for 4 weeks (n=78).	Other: Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEH; Dietary intervention study: high-risk pregnant women receiving a link to MOH general dietary recommendations for pregnancy (MOH recommendations) with addition of three tablespoon (42 ml) EVOOEH (up to 0.8% free acidity) per day at each morning for four weeks during the first half of pregnancy (gestational ages between 8 to 16 weeks)
Other: Control arm; MOH recommendations for 4 weeks (n=78).	Other: Dietary MOH recommendations; Dietary intervention study: high-risk pregnant women receiving a link to MOH general dietary recommendations for pregnancy (MOH recommendations) for four weeks during the first half of pregnancy (gestational ages between 8 to 16 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sFlt-1/PlGF ratio	Post intervention serum sFlt-1/PlGF ratio at the end of intervention.	4 weeks
GCT result	Post intervention maternal GCT result at the end of intervention.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBP	Maternal systolic diastolic blood pressure	At recruitment and approximately 4 weeks post intervention initiation
DBP	Maternal diastolic diastolic blood pressure	At recruitment and approximately 4 weeks post intervention initiation
PE	PE diagnosis	From intervention to delivery
GDM	GDM diagnosis	From intervention to delivery
CS	Cesarean section incidence	At delivery
Preterm	Preterm incidence	At birth
SGA	SGA incidence	At birth
Birthweight percentile	Newborn adjusted with percentile	At birth

Collaborators and Investigators

• Sponsor: Yaniv Ovadia
• Investigators: Study Director: Dr Yaniv S. Ovadia, RD PhD, Barzilai University Medical Center Ashkelon

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): January 7, 2028

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 29, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: prevention; dietary intervention; preeclampsia; Extra virgin olive oil from early harvested olives; FMS-like tyrosine kinase 1; plasma hydroxytyrosol; point Mediterranean Diet Adherence Screener
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 0049-24-BRZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No