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

NCT06759545 | Recruiting DMC

• 1 other identifier: 0049-24-BRZ
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• SBP

  At recruitment and approximately 4 weeks post intervention initiation

• DBP

  At recruitment and approximately 4 weeks post intervention initiation

• PE

  From intervention to delivery

• GDM

  From intervention to delivery

• CS

  At delivery

Study Arms (2)

EVOOEH arm

EXPERIMENTAL

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

Control arm

OTHER

MOH recommendations for 4 weeks (n=78).

Other: Dietary MOH recommendations

Interventions

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

EVOOEH arm

Dietary MOH recommendations 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)

Control arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Refusing enrollment or participation.

Sponsors & Collaborators

• Yaniv Ovadia: lead

Study Sites (1)

Barzilai University Medical Center

Ashkelon, Ashkelon District, 7830604, Israel

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dr Yaniv S. Ovadia, RD PhD

  Barzilai University Medical Center Ashkelon

  STUDY DIRECTOR

Central Study Contacts

Yaniv Dr Yaniv S. Ovadia, RD PhD

CONTACT

+ 972 8 6745220; yaniv.ovadia@mail.huji.ac.il

Arie Dr Arie Budovsky, PhD

CONTACT

+ 972 8 6746146; arieb@bmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Yaniv S. Ovadia RD PhD

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 6, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): January 7, 2028
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)