Clinical trial NCT06759545: An Interventional Pilot Study on the Effect of Extra Virgin Olive Oil on Women with Preeclampsia Risk
Official title: Effect of Extra Virgin Olive Oil Addition in the Diet of Women with Higher Risk for Preeclampsia - Interventional Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: sFlt-1/PlGF ratio
timeFrame: 4 weeks
measure: GCT result
timeFrame: 4 weeks
Secondary outcomes:
measure: SBP
timeFrame: At recruitment and approximately 4 weeks post intervention initiation
measure: DBP
timeFrame: At recruitment and approximately 4 weeks post intervention initiation
measure: PE
timeFrame: From intervention to delivery
measure: GDM
timeFrame: From intervention to delivery
measure: CS
timeFrame: At delivery
measure: Preterm
timeFrame: At birth
measure: SGA
timeFrame: At birth
measure: Birthweight percentile
timeFrame: At birth
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai University Medical Center
state: Ashkelon District
Study officials:
affiliation: Barzilai University Medical Center Ashkelon
name: Dr Yaniv S. Ovadia, RD PhD
role: STUDY_DIRECTOR
References: