Placental Passage of Free and Esterified Phytosterols in Humans
PTS
The Maternal-fetal Gradient of Free and Esterified Phytosterols in Term Human Pregnancy at Delivery
1 other identifier
observational
68
0 countries
N/A
Brief Summary
Total plasma cholesterol rises by 60 % with progressing pregnancy in humans. Because lipid-lowering drugs are contraindicated during pregnancy, natural compounds, such as phytosterols, may be a safe and effective alternative to prevent undesirable effects. Information on phytosterols in pregnancy is so far very limited. To date, to the best of our knowledge, no studies have characterized the maternal-fetal gradient of free and esterified phytosterols in full-term human pregnancy. For this purpose, maternal and cord blood cholesterol and non-cholesterol sterol (campesterol, stigmasterol, sitosterol) concentrations were measured in term pregnant women at delivery by using gas chromatography-mass spectrometry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2017
CompletedFirst Submitted
Initial submission to the registry
November 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedOctober 15, 2018
October 1, 2018
5 months
November 13, 2017
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Free and esterified phytosterol ratio
Plasma free and esterified phytosterol concentrations will be measured in mother-cord blood pairs at delivery. Plasma phytosterol concentrations will be the sum of plasma campesterol, stigmasterol and sitosterol concentrations (mg/L). Gas chromatography-mass spectrometry will be used for measurements.
the day of delivery
Secondary Outcomes (5)
total cholesterol concentrations
the day of delivery
total lathosterol concentrations
the day of delivery
total 7-dehydrocholesterol concentrations
the day of delivery
total 7-alpha-hydroxycholesterol concentrations
the day of delivery
fatty acid concentrations
the day of delivery
Eligibility Criteria
Pregnant women
You may qualify if:
- A single pregnancy
- 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.
You may not qualify if:
- Major congenital anomalies
- Maternal history of cardiovascular disease
- Endocrine disorders such as diabetes, hypercholesterolemia, pre-eclampsia, thyroid or adrenal problems
- Clinical chorioamnionitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (8)
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.
PMID: 1446807BACKGROUNDRideout 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.
PMID: 26084365BACKGROUNDBerger 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.
PMID: 15070410BACKGROUNDPiccoli 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.
PMID: 25600902BACKGROUNDGao 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.
PMID: 28091647BACKGROUNDNikkila 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.
PMID: 9017519RESULTMiettinen 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.
PMID: 25301963RESULTVuorio 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.
PMID: 12080326RESULT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Phd, Professor of Neonatal Pediatrics
Study Record Dates
First Submitted
November 13, 2017
First Posted
October 15, 2018
Study Start
October 26, 2016
Primary Completion
March 31, 2017
Study Completion
October 15, 2017
Last Updated
October 15, 2018
Record last verified: 2018-10