Preeclampsia (PE) RiskNCT06759545
An Interventional Pilot Study on the Effect of Extra Virgin Olive Oil on Women with Preeclampsia Risk
A study testing Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEH and Dietary MOH recommendations in people with Preeclampsia (PE) Risk, run by Yaniv Ovadia at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia (PE) Risk
- What is being tested?
- Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEH and Dietary MOH recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Jan 2025to 7 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Refusing enrollment or participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Barzilai University Medical Center
Ashkelon, Ashkelon District, 7830604
Dr Yaniv Ovadia, RD PhD, + 972 54 8111174, yaniv.ovadia@mail.huji.ac.il
Dr Arie Budovsky, PhD, arieb@bmc.gov.il
About this study
Official title: 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.
Read more
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
- Being tested
- Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEH, Dietary MOH recommendations
- 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
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEHOther
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)
Dietary MOH recommendationsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| EVOOEH arm | Experimental | Daily addition of 42 ml (three tablespoon) at each morning of EVOOEH to MOH recommendations for 4 weeks (n=78). Receives: 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). Receives: Other: Dietary MOH recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
sFlt-1/PlGF ratio
Post intervention serum sFlt-1/PlGF ratio at the end of intervention.
Measured: 4 weeks
GCT result
Post intervention maternal GCT result at the end of intervention.
Measured: 4 weeks
Secondary outcomes (8)
SBP
Maternal systolic diastolic blood pressure
Measured: At recruitment and approximately 4 weeks post intervention initiation
DBP
Maternal diastolic diastolic blood pressure
Measured: At recruitment and approximately 4 weeks post intervention initiation
PE
PE diagnosis
Measured: From intervention to delivery
GDM
GDM diagnosis
Measured: From intervention to delivery
CS
Cesarean section incidence
Measured: At delivery
Preterm
Preterm incidence
Measured: At birth
SGA
SGA incidence
Measured: At birth
Birthweight percentile
Newborn adjusted with percentile
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start28 Jan 2025
- Primary completion7 Jan 2027 (estimated)
- Study completion7 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preeclampsia (PE) RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaniv Ovadia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaniv Ovadia, Barzilai Medical Center
- Investigators
- Dr Yaniv S. Ovadia, RD PhD, Study director, Barzilai University Medical Center Ashkelon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759545
- Sponsor's protocol ID
- 0049-24-BRZ
- Status last verified
- Feb 2025
- First submitted
- 17 Dec 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ovadia YS, Navarro DA, Rimler A, Brandis A, Ditchi E, Monsonego-Ornan E, Solt I, Anteby EY, Shenhav S. An interventional pilot study protocol on the effect of extra virgin olive oil on women with preeclampsia risk. Ann Transl Med. 2026 Feb 28;14(1):5. doi: 10.21037/atm-25-122. Epub 2026 Feb 25.
PubMed 41835790
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extra Virgin Olive Oil Addition in the Diet of Women with Higher Risk for Preeclampsia - Interventional Pilot Study
- ClinicalTrials.gov ID
- NCT06759545
- Acronym / sponsor ID
- 0049-24-BRZ
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Yaniv OvadiaUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 7 Jan 2028 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVOOEH arm | Experimental | Other: Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEHDaily addition of 42 ml (three tablespoon) at each morning of EVOOEH to MOH recommendations for 4 weeks (n=78). |
| Control arm | Other | Other: Dietary MOH recommendationsMOH recommendations for 4 weeks (n=78). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Refusing enrollment or participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEHDietary 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 | EVOOEH arm |
| Dietary MOH recommendationsDietary 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) | Other | Control arm |
Primary outcome
sFlt-1/PlGF ratio
Time frame: 4 weeks
Post intervention serum sFlt-1/PlGF ratio at the end of intervention.
GCT result
Time frame: 4 weeks
Post intervention maternal GCT result at the end of intervention.
8 secondary outcomes
SBP
Time frame: At recruitment and approximately 4 weeks post intervention initiation
DBP
Time frame: At recruitment and approximately 4 weeks post intervention initiation
PE
Time frame: From intervention to delivery
GDM
Time frame: From intervention to delivery
CS
Time frame: At delivery
Preterm
Time frame: At birth
SGA
Time frame: At birth
Birthweight percentile
Time frame: At birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 41835790Ovadia YS, Navarro DA, Rimler A, Brandis A, Ditchi E, Monsonego-Ornan E, Solt I, Anteby EY, Shenhav S. An interventional pilot study protocol on the effect of extra virgin olive oil on women with preeclampsia risk. Ann Transl Med. 2026 Feb 28;14(1):5. doi: 10.21037/atm-25-122. Epub 2026 Feb 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Yaniv S. Ovadia, RD PhD study director
Barzilai University Medical Center Ashkelon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary MOH recommendations and daily addition of 42 ml (three tablespoon) at each morning of EVOOEH and Dietary MOH recommendations in people with Preeclampsia (PE) Risk, run by Yaniv Ovadia at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaniv Dr Yaniv S. Ovadia, RD PhD (+ 972 8 6745220, yaniv.ovadia@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sFlt-1/PlGF ratio (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06759545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.