Lipid Profile in PregnancyOM3NCT02925013
Maternal Dietary Lipids and Omega 3 Essential Fatty Acids Profile in Pregnant Women at Term and Their Fetuses
A study testing Blood sampling and Dietary- Normal western diet in people with Lipid Profile in Pregnancy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This study aims to investigate the omega 3 lipid profile in pregnant women at term and their fetuses compared to non pregnant women , in normal western diet adding no supplementation Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Profile in Pregnancy
- What is being tested?
- Blood sampling and Dietary- Normal western diet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2018to 30 Oct 2021
- Phase
- Interventional
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women in labor( above 34 weeks of gestation )
- Age:18-42
Who cannot join
- taking any kind of dietary supplementation
- hyperlipidemia / hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the omega 3 lipid profile in pregnant women at term and their fetuses compared to non pregnant women , in normal western diet adding no supplementation
Read the detailed description
DHA (Docosahexaenoic Acid ) is a long chain omega-3 fatty acid important for brain and eye development and function throughout life. It also supports heart health. DHA is the most abundant omega-3 in the brain and retina and is naturally found in breast milk. EPA (Eicosapentaenoic Acid ) is a long-chain omega-3 fatty acid important for overall health. However, unlike DHA, the body does not store EPA in significant quantities in the brain or retina (DHA is found in every cell throughout the body, EPA is not). These Omega 3 fatty acids are considered essential due to the inability of the human body to create them and the need to consume them from nutritional source. Food that is considered rich in omega 3 fatty acids are fat fish and green vegetables. Omega-3 fatty acids are "good fats," and are among the most important nutrients lacking in Western diets today. The average person in developed countries consumes less than 100 mg of DHA daily. With increasing awareness of the importance of DHA, many people realize that they need to make a change to their diet by adding DHA-rich foods or supplements.
Alpha Linolenic Acid (ALA) is a shorter-chain omega-3 that serves as a source of energy and as a building block for long-chain omega-3 fatty acids (DHA and EPA). This precursor for omega 3 fatty acid is abundant in falx seeds. The mother and the fetus has the metabolic mechanism that enables them to transform ALA into EPA,DHA endogenously.
Women during pregnancy are predisposed to a reduction in unsaturated long chain fatty acid (polyunsaturated Fatty Acid = PUFA) from the omega 3 group . Lately, a new hypothesis claiming that a reduced level of this essential acids expose the fetus later in his adult life to a spectrum of metabolic and cardiovascular disease. New publication on animal models showed higher rates of obesity, insulin resistance diabetes and cardiovascular damage on mice exposed short chain fatty acids compared to those treated with enriched ALA diet supplementation. Different nutritional and gynecological health organization around the world including the FDA, recommend incorporating omega 3 fatty acids supplementation to daily diet and specifically in pregnant women in order to raise their blood levels for the developing fetus. However, normal fatty acid profile of the omega 3 group in mother and fetus haven't been described yet . Furthermore, the total effect and future benefit to fetus haven't been thoroughly studied and is based mainly on presumptions.
The aim of this study is to learn the typical omega 3 fatty acid profile at women near delivery and their fetuses and to compare it to women in productive years that are not pregnant.
Study methods:
Women close to term visiting the obstetrical triage and fitting inclusion criteria will be offered to participate in the study. Demographic medical and obstetrical information will be collected from medical files after giving signed informed consent .
Blood sample ( one blood tube that will include 5 cc of blood ) will be taken while insertion of intravenous line in the delivery room, and another blood sample will be taken from the umbilical vein after delivery and separation of the fetus from the umbilical cord.
Women for control group - healthy non pregnant women in fertility years, will be recruited from the gynecological clinic . Similarly to the study group, one of the study researchers will collect one tube for blood sampling ( equal to 5 cc of blood ).
All samples will be sent for profile analysis of omega 3 fatty acids.
- Conditions
- Lipid Profile in Pregnancy
- Being tested
- Blood sampling, Dietary- Normal western diet
- Keywords
- Omega 3, Lipids, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sampling for lipid profile
Dietary- Normal western dietOther
Normal western diet
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Pregnant women at delivery Receives: Procedure: Blood sampling; Other: Dietary- Normal western diet |
| Control group | Other | Women in fertility age not pregnant Receives: Procedure: Blood sampling; Other: Dietary- Normal western diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega 3 lipid profile in pregnant women at term
Measured: through study completion, an average of 1year
Omega 3 lipid profile in umbilical vein
Measured: through study completion, an average of 1year
Omega 3 lipid profile in women in fertility age
Measured: through study completion, an average of 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Jul 2018
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lipid Profile in PregnancyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925013
- Sponsor's protocol ID
- 9649-12
- Acronym
- OM3
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2016
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mennitti LV, Oliveira JL, Morais CA, Estadella D, Oyama LM, Oller do Nascimento CM, Pisani LP. Type of fatty acids in maternal diets during pregnancy and/or lactation and metabolic consequences of the offspring. J Nutr Biochem. 2015 Feb;26(2):99-111. doi: 10.1016/j.jnutbio.2014.10.001. Epub 2014 Oct 12.
PubMed 25459884Leikin-Frenkel AI. Is there A Role for Alpha-Linolenic Acid in the Fetal Programming of Health? J Clin Med. 2016 Mar 23;5(4):40. doi: 10.3390/jcm5040040.
PubMed 27023621Barker DJ. Fetal origins of coronary heart disease. Br Heart J. 1993 Mar;69(3):195-6. doi: 10.1136/hrt.69.3.195. No abstract available.
PubMed 8461215Hollander KS, Tempel Brami C, Konikoff FM, Fainaru M, Leikin-Frenkel A. Dietary enrichment with alpha-linolenic acid during pregnancy attenuates insulin resistance in adult offspring in mice. Arch Physiol Biochem. 2014 Jul;120(3):99-111. doi: 10.3109/13813455.2014.940352. Epub 2014 Jul 17.
PubMed 25030769Shomonov-Wagner L, Raz A, Leikin-Frenkel A. Alpha linolenic acid in maternal diet halts the lipid disarray due to saturated fatty acids in the liver of mice offspring at weaning. Lipids Health Dis. 2015 Feb 26;14:14. doi: 10.1186/s12944-015-0012-7.
PubMed 25889505Leikin-Frenkel A, Shomonov-Wagner L, Juknat A, Pasmanik-Chor M. Maternal Diet Enriched with alpha-Linolenic or Saturated Fatty Acids Differentially Regulates Gene Expression in the Liver of Mouse Offspring. J Nutrigenet Nutrigenomics. 2015;8(4-6):185-94. doi: 10.1159/000442945. Epub 2016 Jan 21.
PubMed 26788914Kabaran S, Besler HT. Do fatty acids affect fetal programming? J Health Popul Nutr. 2015 Aug 13;33:14. doi: 10.1186/s41043-015-0018-9.
PubMed 26825664
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Dietary Lipids and Omega 3 Essential Fatty Acids Profile in Pregnant Women at Term and Their Fetuses
- ClinicalTrials.gov ID
- NCT02925013
- Acronym / sponsor ID
- OM3 / 9649-12
- Conditions
- Lipid Profile in Pregnancy
- Keywords
- Omega 3, Lipids, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 5 Oct 2016 (estimated)
- 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 aims to investigate the omega 3 lipid profile in pregnant women at term and their fetuses compared to non pregnant women , in normal western diet adding no supplementation
Detailed description
DHA (Docosahexaenoic Acid ) is a long chain omega-3 fatty acid important for brain and eye development and function throughout life. It also supports heart health. DHA is the most abundant omega-3 in the brain and retina and is naturally found in breast milk. EPA (Eicosapentaenoic Acid ) is a long-chain omega-3 fatty acid important for overall health. However, unlike DHA, the body does not store EPA in significant quantities in the brain or retina (DHA is found in every cell throughout the body, EPA is not). These Omega 3 fatty acids are considered essential due to the inability of the human body to create them and the need to consume them from nutritional source. Food that is considered rich in omega 3 fatty acids are fat fish and green vegetables. Omega-3 fatty acids are "good fats," and are among the most important nutrients lacking in Western diets today. The average person in developed countries consumes less than 100 mg of DHA daily. With increasing awareness of the importance of DHA, many people realize that they need to make a change to their diet by adding DHA-rich foods or supplements.
Alpha Linolenic Acid (ALA) is a shorter-chain omega-3 that serves as a source of energy and as a building block for long-chain omega-3 fatty acids (DHA and EPA). This precursor for omega 3 fatty acid is abundant in falx seeds. The mother and the fetus has the metabolic mechanism that enables them to transform ALA into EPA,DHA endogenously.
Women during pregnancy are predisposed to a reduction in unsaturated long chain fatty acid (polyunsaturated Fatty Acid = PUFA) from the omega 3 group . Lately, a new hypothesis claiming that a reduced level of this essential acids expose the fetus later in his adult life to a spectrum of metabolic and cardiovascular disease. New publication on animal models showed higher rates of obesity, insulin resistance diabetes and cardiovascular damage on mice exposed short chain fatty acids compared to those treated with enriched ALA diet supplementation. Different nutritional and gynecological health organization around the world including the FDA, recommend incorporating omega 3 fatty acids supplementation to daily diet and specifically in pregnant women in order to raise their blood levels for the developing fetus. However, normal fatty acid profile of the omega 3 group in mother and fetus haven't been described yet . Furthermore, the total effect and future benefit to fetus haven't been thoroughly studied and is based mainly on presumptions.
The aim of this study is to learn the typical omega 3 fatty acid profile at women near delivery and their fetuses and to compare it to women in productive years that are not pregnant.
Study methods:
Women close to term visiting the obstetrical triage and fitting inclusion criteria will be offered to participate in the study. Demographic medical and obstetrical information will be collected from medical files after giving signed informed consent .
Blood sample ( one blood tube that will include 5 cc of blood ) will be taken while insertion of intravenous line in the delivery room, and another blood sample will be taken from the umbilical vein after delivery and separation of the fetus from the umbilical cord.
Women for control group - healthy non pregnant women in fertility years, will be recruited from the gynecological clinic . Similarly to the study group, one of the study researchers will collect one tube for blood sampling ( equal to 5 cc of blood ).
All samples will be sent for profile analysis of omega 3 fatty acids.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Blood sampling, Other: Dietary- Normal western dietPregnant women at delivery |
| Control group | Other | Procedure: Blood sampling, Other: Dietary- Normal western dietWomen in fertility age not pregnant |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women in labor( above 34 weeks of gestation )
- Age:18-42
Key exclusion criteria (2 listed)
- taking any kind of dietary supplementation
- hyperlipidemia / hypercholesterolemia
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 |
|---|---|---|
| Blood samplingBlood sampling for lipid profile | Procedure or surgery | Control group, Study group |
| Dietary- Normal western dietNormal western diet | Other | Control group, Study group |
Primary outcome
Omega 3 lipid profile in pregnant women at term
Time frame: through study completion, an average of 1year
Omega 3 lipid profile in umbilical vein
Time frame: through study completion, an average of 1year
Omega 3 lipid profile in women in fertility age
Time frame: through study completion, an average of 1year
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 11 Nov 2021.
- Background: PubMed 25459884Mennitti LV, Oliveira JL, Morais CA, Estadella D, Oyama LM, Oller do Nascimento CM, Pisani LP. Type of fatty acids in maternal diets during pregnancy and/or lactation and metabolic consequences of the offspring. J Nutr Biochem. 2015 Feb;26(2):99-111. doi: 10.1016/j.jnutbio.2014.10.001. Epub 2014 Oct 12.
- Background: PubMed 27023621Leikin-Frenkel AI. Is there A Role for Alpha-Linolenic Acid in the Fetal Programming of Health? J Clin Med. 2016 Mar 23;5(4):40. doi: 10.3390/jcm5040040.
- Background: PubMed 8461215Barker DJ. Fetal origins of coronary heart disease. Br Heart J. 1993 Mar;69(3):195-6. doi: 10.1136/hrt.69.3.195. No abstract available.
- Background: PubMed 25030769Hollander KS, Tempel Brami C, Konikoff FM, Fainaru M, Leikin-Frenkel A. Dietary enrichment with alpha-linolenic acid during pregnancy attenuates insulin resistance in adult offspring in mice. Arch Physiol Biochem. 2014 Jul;120(3):99-111. doi: 10.3109/13813455.2014.940352. Epub 2014 Jul 17.
- Background: PubMed 25889505Shomonov-Wagner L, Raz A, Leikin-Frenkel A. Alpha linolenic acid in maternal diet halts the lipid disarray due to saturated fatty acids in the liver of mice offspring at weaning. Lipids Health Dis. 2015 Feb 26;14:14. doi: 10.1186/s12944-015-0012-7.
- Background: PubMed 26788914Leikin-Frenkel A, Shomonov-Wagner L, Juknat A, Pasmanik-Chor M. Maternal Diet Enriched with alpha-Linolenic or Saturated Fatty Acids Differentially Regulates Gene Expression in the Liver of Mouse Offspring. J Nutrigenet Nutrigenomics. 2015;8(4-6):185-94. doi: 10.1159/000442945. Epub 2016 Jan 21.
- Background: PubMed 26825664Kabaran S, Besler HT. Do fatty acids affect fetal programming? J Health Popul Nutr. 2015 Aug 13;33:14. doi: 10.1186/s41043-015-0018-9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Dietary- Normal western diet in people with Lipid Profile in Pregnancy, run by Sheba Medical Center 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 2 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 11 Nov 2021. 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?
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?
Omega 3 lipid profile in pregnant women at term (time frame: through study completion, an average of 1year). The study lists 3 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 NCT02925013, which also lists 7 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 11 Nov 2021.