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

NCT ID: NCT06759545

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2028-01-07

Brief Summary

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.

Conditions

Preeclampsia (PE) Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

EVOOEH arm

Daily addition of 42 ml (three tablespoon) at each morning of EVOOEH to MOH recommendations for 4 weeks (n=78).

Group Type: EXPERIMENTAL

Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEH

Intervention Type: OTHER

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)

Control arm

MOH recommendations for 4 weeks (n=78).

Group Type: OTHER

Dietary MOH recommendations

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yaniv Ovadia

OTHER

Sponsor Role: lead

Responsible Party

Yaniv Ovadia

Dr Yaniv S. Ovadia RD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dr Yaniv S. Ovadia, RD PhD

Role: STUDY_DIRECTOR

Barzilai University Medical Center Ashkelon

Locations

Barzilai University Medical Center

Ashkelon, Ashkelon District, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yaniv Dr Yaniv S. Ovadia, RD PhD

Role: CONTACT

yaniv.ovadia@mail.huji.ac.il

+ 972 8 6745220

Arie Dr Arie Budovsky, PhD

Role: CONTACT

arieb@bmc.gov.il

+ 972 8 6746146

Facility Contacts

Dr Yaniv Ovadia, RD PhD

Role: primary

yaniv.ovadia@mail.huji.ac.il

+ 972 54 8111174

Dr Arie Budovsky, PhD

Role: backup

arieb@bmc.gov.il

Other Identifiers

0049-24-BRZ

Identifier Type: -

Identifier Source: org_study_id