Mother Fetus RelationsPTSNCT03705767
Placental Passage of Free and Esterified Phytosterols in Humans
An observational study of Mother Fetus Relations, run by Università Politecnica delle Marche.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother Fetus Relations
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2016to 15 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- 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.
Who cannot join
- Major congenital anomalies
- Maternal history of cardiovascular disease
- Endocrine disorders such as diabetes, hypercholesterolemia, pre-eclampsia, thyroid or adrenal problems
- Clinical chorioamnionitis
About this study
Official title: The Maternal-fetal Gradient of Free and Esterified Phytosterols in Term Human Pregnancy at Delivery
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.
- Conditions
- Mother Fetus Relations
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the day of delivery
Secondary outcomes (5)
total cholesterol concentrations
plasma cholesterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total cholesterol in pregnant women and cord blood will be calculated from plasma free and esterified cholesterol. Cholesterol concentrations will be measured by using gas chromatography-mass spectrometry.
Measured: the day of delivery
total lathosterol concentrations
plasma lathosterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total lathosterol in pregnant women and cord blood will be calculated from plasma free and esterified lathosterol. Lathosterol concentrations will be measured by using gas chromatography-mass spectrometry.
Measured: the day of delivery
total 7-dehydrocholesterol concentrations
plasma 7-dehydrocholesterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total 7-dehydrocholesterol in pregnant women and cord blood will be calculated from plasma free and esterified 7-dehydrocholesterol.
7-dehydrocholesterol concentrations will be measured by using gas chromatography-mass spectrometry.
Measured: the day of delivery
total 7-alpha-hydroxycholesterol concentrations
plasma 7-alpha-hydroxycholesterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total 7-alpha-hydroxycholesterol in pregnant women and cord blood will be calculated from plasma free and esterified 7-alpha-hydroxycholesterol. 7-alpha-hydroxycholesterol concentrations will be measured by using gas chromatography-mass spectrometry.
Measured: the day of delivery
fatty acid concentrations
plasma fatty acid concentrations (mg/dl) will be measured to evaluate the fat metabolism in mother-cord blood pairs at delivery. Total fatty acids will be measured by using gas chromatography with flame ionization detector will be used for the measurement of fatty acids.
Measured: the day of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start26 Oct 2016
- Primary completion31 Mar 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mother Fetus RelationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virgilio Paolo Carnielli, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705767
- Sponsor's protocol ID
- PTS1
- Acronym
- PTS
- Status last verified
- Oct 2018
- First submitted
- 13 Nov 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 1446807Rideout 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.
PubMed 26084365Berger 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.
PubMed 15070410Piccoli 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.
PubMed 25600902Gao 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.
PubMed 28091647Nikkila 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.
PubMed 9017519Miettinen 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.
PubMed 25301963Vuorio 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.
PubMed 12080326
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maternal-fetal Gradient of Free and Esterified Phytosterols in Term Human Pregnancy at Delivery
- ClinicalTrials.gov ID
- NCT03705767
- Acronym / sponsor ID
- PTS / PTS1
- Conditions
- Mother Fetus Relations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 15 Oct 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Major congenital anomalies
- Maternal history of cardiovascular disease
- Endocrine disorders such as diabetes, hypercholesterolemia, pre-eclampsia, thyroid or adrenal problems
- Clinical chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Free and esterified phytosterol ratio
Time frame: the day of delivery
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.
5 secondary outcomes
total cholesterol concentrations
Time frame: the day of delivery
total lathosterol concentrations
Time frame: the day of delivery
total 7-dehydrocholesterol concentrations
Time frame: the day of delivery
total 7-alpha-hydroxycholesterol concentrations
Time frame: the day of delivery
fatty acid concentrations
Time frame: the day of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 1446807Montelongo 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.
- Background: PubMed 26084365Rideout 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.
- Background: PubMed 15070410Berger 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.
- Background: PubMed 25600902Piccoli 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.
- Background: PubMed 28091647Gao 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.
- Results publication: PubMed 9017519Nikkila 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.
- Results publication: PubMed 25301963Miettinen 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.
- Results publication: PubMed 12080326Vuorio 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mother Fetus Relations, run by Università Politecnica delle Marche.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free and esterified phytosterol ratio (time frame: the day of delivery). 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 NCT03705767, which also lists 8 linked publications.
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 15 Oct 2018.