Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels

NCT06567951 | Not Yet Recruiting DMC

• 1 other identifier: Fondecyt 1230527
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to know if supplementation with extra virgin olive oil (EVOO) during pregnancy, improves the maternal and neonatal lipoprotein profile, lipoprotein function, oxidative status and vascular dysfunction markers in pregnancies with maternal supraphysiological hypercholesterolemia (MSPH). The main questions to be answered are:

1. 1.Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH women at the end of pregnancy?
2. 2.Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH neonates at the end of pregnancy? The investigators will compare regular diet supplemented with EVOO vs. intake of a non-supplemented regular diet to determine if EVOO reduces impaired vascular and lipid outcomes in the mother and her newborn.

Conditions

Pregnancy Related; Hypercholesterolemia

Keywords

Pregnancy; Cholesterol; Vascular function; Lipoprotein function; Extra virgin olive oil

Outcome Measures

Primary Outcomes (3)

• Lipoprotein function

  At the end of pregnancy lipoprotein function determined as conjugated dienes formation (concentration vs time) will be evaluated by ultraviolet absorbance in lipoproteins isolated from maternal and umbilical cord blood

  48 weeks after the end of pregnancy or 60 weeks after randomization

• Oxidative status

  At the end of pregnancy oxidative status determined as concentration of oxidized LDL (mg/dL) will be evaluated by ELISA in maternal and umbilical cord blood

  48 weeks after the end of pregnancy or 60 weeks after randomization

• Lipid profile

  At the end of pregnancy, lipoprotein profile determined as concentration of total cholesterol, LDL, HDL and triglycerides (mg/dL) will be evaluated in the clinical laboratory in maternal and umbilical cord blood

  10 weeks after the end of each pregnancy or 22 weeks after randomization.

Secondary Outcomes (3)

• Markers of endothelial dysfunction

  48 week after pregnancy or 60 weeks after randomization

• Determination of adherence to a mediterranean diet

  The adherence to mediterranean diet will be evaluated 4, 8 and 12 weeks after randomization

• Determination of adherence to EVOO supplementation by food frequency questionnaire

  The FFQ will be evaluated 4, 8 and 12 weeks after randomization.

Study Arms (2)

Control group (without EVOO supplementation)

NO INTERVENTION

No intervention will be performed in this group of participants

EVOO group (with EVOO supplementation)

EXPERIMENTAL

The intervention will be daily EVOO suplementation (36mL) form gestational week 28 until delivery

Dietary Supplement: Extra Virgin Olive Oil (EVOO)

Interventions

Extra Virgin Olive Oil (EVOO) DIETARY_SUPPLEMENT

This is the first time that prengnt women with maternal supraphysiological hypercholesterolemia will be suplemented with EVOO during pregnancy. The intervention will be daily EVOO suplementation (36mL) form gestational week 28 until delivery

EVOO group (with EVOO supplementation)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women at 26-28 weeks of gestation
• Singleton pregnancies
• Pregnancies without fetal malformations

You may not qualify if:

• Pregnant women with pre-gestational and/or gestational diabetes mellitus
• Pregnant women with obesity before or during pregnancy
• Pregnant women with pre-eclampsia,
• Pregnant women with pregnancy hypertensive syndrome
• Pregnant women with fetal growth retardation

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Universidad San Sebastián: collaborator

Study Sites (1)

Clinica Universidad de los Andes

Santiago, Las Condes, Chile

Location

Related Publications (6)

• Napoli C, Glass CK, Witztum JL, Deutsch R, D'Armiento FP, Palinski W. Influence of maternal hypercholesterolaemia during pregnancy on progression of early atherosclerotic lesions in childhood: Fate of Early Lesions in Children (FELIC) study. Lancet. 1999 Oct 9;354(9186):1234-41. doi: 10.1016/S0140-6736(99)02131-5.

  PMID: 10520631 BACKGROUND

• Liguori A, D'Armiento FP, Palagiano A, Balestrieri ML, Williams-Ignarro S, de Nigris F, Lerman LO, D'Amora M, Rienzo M, Fiorito C, Ignarro LJ, Palinski W, Napoli C. Effect of gestational hypercholesterolaemia on omental vasoreactivity, placental enzyme activity and transplacental passage of normal and oxidised fatty acids. BJOG. 2007 Dec;114(12):1547-56. doi: 10.1111/j.1471-0528.2007.01510.x. Epub 2007 Sep 27.

  PMID: 17903226 BACKGROUND

• Leiva A, de Medina CD, Salsoso R, Saez T, San Martin S, Abarzua F, Farias M, Guzman-Gutierrez E, Pardo F, Sobrevia L. Maternal hypercholesterolemia in pregnancy associates with umbilical vein endothelial dysfunction: role of endothelial nitric oxide synthase and arginase II. Arterioscler Thromb Vasc Biol. 2013 Oct;33(10):2444-53. doi: 10.1161/ATVBAHA.113.301987. Epub 2013 Aug 15.

  PMID: 23950140 BACKGROUND

• Guasch-Ferre M, Li Y, Willett WC, Sun Q, Sampson L, Salas-Salvado J, Martinez-Gonzalez MA, Stampfer MJ, Hu FB. Consumption of Olive Oil and Risk of Total and Cause-Specific Mortality Among U.S. Adults. J Am Coll Cardiol. 2022 Jan 18;79(2):101-112. doi: 10.1016/j.jacc.2021.10.041.

  PMID: 35027106 BACKGROUND

• Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.

  PMID: 29897866 BACKGROUND

• Gomez Ribot D, Diaz E, Fazio MV, Gomez HL, Fornes D, Macchi SB, Gresta CA, Capobianco E, Jawerbaum A. An extra virgin olive oil-enriched diet improves maternal, placental, and cord blood parameters in GDM pregnancies. Diabetes Metab Res Rev. 2020 Nov;36(8):e3349. doi: 10.1002/dmrr.3349. Epub 2020 Jun 24.

  PMID: 32447799 BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrea Leiva, PhD

  Universidad San Sebastian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Illanes, MD

CONTACT

56 982338204; sillanes@uandes.cl

Andrea Leiva, PhD

CONTACT

56988091715; andrea.leiva@uss.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Detaile design was described in "Study Description" section. In brief: MPH and MSPH will be (or not) daily supplemented with 36 ml of EVOO from gestational week 28 to the end of pregnancy.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 23, 2024
• Study Start: September 10, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)