Placental Passage of Free and Esterified Phytosterols in Humans
NCT ID: NCT03705767
Last Updated: 2018-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
68 participants
OBSERVATIONAL
2016-10-26
2017-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* A gestational age determined from known last maternal menstrual period higher than 37 weeks
* A normal diet without phytosterol supplementation during pregnancy
* Written informed consent available.
Exclusion Criteria
* Maternal history of cardiovascular disease
* Endocrine disorders such as diabetes, hypercholesterolemia, pre-eclampsia, thyroid or adrenal problems
* Clinical chorioamnionitis
20 Years
40 Years
FEMALE
Yes
Sponsors
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Università Politecnica delle Marche
OTHER
Responsible Party
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Virgilio Paolo Carnielli
MD, Phd, Professor of Neonatal Pediatrics
References
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Montelongo A, Lasuncion MA, Pallardo LF, Herrera E. Longitudinal study of plasma lipoproteins and hormones during pregnancy in normal and diabetic women. Diabetes. 1992 Dec;41(12):1651-9. doi: 10.2337/diab.41.12.1651.
Rideout TC, Movsesian C, Tsai YT, Iqbal A, Raslawsky A, Patel MS. Maternal Phytosterol Supplementation during Pregnancy and Lactation Modulates Lipid and Lipoprotein Response in Offspring of apoE-Deficient Mice. J Nutr. 2015 Aug;145(8):1728-34. doi: 10.3945/jn.115.215061. Epub 2015 Jun 17.
Berger A, Jones PJ, Abumweis SS. Plant sterols: factors affecting their efficacy and safety as functional food ingredients. Lipids Health Dis. 2004 Apr 7;3:5. doi: 10.1186/1476-511X-3-5.
Piccoli GB, Clari R, Vigotti FN, Leone F, Attini R, Cabiddu G, Mauro G, Castelluccia N, Colombi N, Capizzi I, Pani A, Todros T, Avagnina P. Vegan-vegetarian diets in pregnancy: danger or panacea? A systematic narrative review. BJOG. 2015 Apr;122(5):623-33. doi: 10.1111/1471-0528.13280. Epub 2015 Jan 20.
Gao F, Wang G, Wang L, Guo N. Phytosterol nutritional supplement improves pregnancy and neonatal complications of gestational diabetes mellitus in a double-blind and placebo-controlled clinical study. Food Funct. 2017 Jan 25;8(1):424-428. doi: 10.1039/c6fo01777k.
Nikkila K, Riikonen S, Lindfors M, Miettinen TA. Serum squalene and noncholesterol sterols before and after delivery in normal and cholestatic pregnancy. J Lipid Res. 1996 Dec;37(12):2687-95.
Miettinen HE, Rono K, Koivusalo S, Stach-Lempinen B, Poyhonen-Alho M, Eriksson JG, Hiltunen TP, Gylling H. Elevated serum squalene and cholesterol synthesis markers in pregnant obese women with gestational diabetes mellitus. J Lipid Res. 2014 Dec;55(12):2644-54. doi: 10.1194/jlr.P049510. Epub 2014 Oct 9.
Vuorio AF, Miettinen TA, Turtola H, Oksanen H, Gylling H. Cholesterol metabolism in normal and heterozygous familial hypercholesterolemic newborns. J Lab Clin Med. 2002 Jul;140(1):35-42. doi: 10.1067/mlc.2002.125214.
Other Identifiers
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PTS1
Identifier Type: -
Identifier Source: org_study_id
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