PregnancyTOTSNCT04349475
Therapeutic Omegas for Triglyceride Suppression
A study testing Intervention Omega 3 Supplementation in people with Pregnancy, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. Read more about this study
- Who is it for?
- Ages 0 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Intervention Omega 3 Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Nov 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women between the ages of 21-39 yrs
- Pre-pregnancy BMI 28-39
- Fasting Triglyceride ≥120 mg/dL measured by 15 wks
Who cannot join
- Pre-gestational diabetes or prediabetes
- History of gestational diabetes,
- History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks
- Tobacco or illicit substance use
- Chronic steroid use
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado/Anschutz Medical Campus
Aurora, Colorado, 80045
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth
This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are ~30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid supplement can slow the rise in triglyceride levels later in pregnancy.
- Conditions
- Pregnancy
- Being tested
- Intervention Omega 3 Supplementation, Placebo Soybean Oil
- Keywords
- triglycerides, glucose, adiposity, Air displacement plethysmography, Continuous glucose monitoring
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Omega 3 SupplementationDietary supplement
Participants will supplement 4g of Omega 3 fish oil daily (750DHA/250EPA)
Placebo Soybean OilDietary supplement
Participants will supplement 4g of Soybean oil daily
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 Supplementation | Experimental | Supplementation of 4g of DHA/EPA daily Receives: Dietary Supplement: Intervention Omega 3 Supplementation |
| Soybean oil | Placebo comparator | Supplementation of 4g Soybean Oil Receives: Dietary Supplement: Placebo Soybean Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Fasting and Postprandial Triglycerides
Differences in maternal fasting and postprandial triglycerides between groups
Measured: 34 weeks gestational age
Secondary outcomes (3)
Mesenchymal Stem Cell Differentiation
Differences in Wnt/β-catenin signaling in mesenchymal stem cells between groups
Measured: Delivery
Placental Nutrient Transport Capacity
We will evaluate placental nutrient-sensing pathways that regulate transporter activity by measuring the abundance and phosphorylation of key components of the insulin/PI3K/Akt and mTOR signaling pathways, including Akt, mTOR, 4E-BP1, and S6K/rpS6, to determine whether O-3 FA supplementation improves placental nutrient sensing and transport regulation.
Measured: Delivery
Nutrient Transport Gene expression
Between-group differences in the expression of placental nutrient transporters GLUT1, GLUT4, FATP2, FATP4, FATP6, and FAT/CD36, and SNAT1, SNAT2, SNAT4, LAT1, LAT2.
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start29 Nov 2021
- Primary completion30 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Teri L Hernandez, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349475
- Sponsor's protocol ID
- 20-0707
- Acronym
- TOTS
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.
PubMed 29931812
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth
- ClinicalTrials.gov ID
- NCT04349475
- Acronym / sponsor ID
- TOTS / 20-0707
- Conditions
- Pregnancy
- Keywords
- triglycerides, glucose, adiposity, Air displacement plethysmography, Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2020 (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.
This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are ~30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid supplement can slow the rise in triglyceride levels later in pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 Supplementation | Experimental | Dietary Supplement: Intervention Omega 3 SupplementationSupplementation of 4g of DHA/EPA daily |
| Soybean oil | Placebo comparator | Dietary Supplement: Placebo Soybean OilSupplementation of 4g Soybean Oil |
Who may qualify
- Ages
- 0 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant women between the ages of 21-39 yrs
- Pre-pregnancy BMI 28-39
- Fasting Triglyceride ≥120 mg/dL measured by 15 wks
Key exclusion criteria (5 listed)
- Pre-gestational diabetes or prediabetes
- History of gestational diabetes,
- History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks
- Tobacco or illicit substance use
- Chronic steroid use
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 |
|---|---|---|
| Intervention Omega 3 SupplementationParticipants will supplement 4g of Omega 3 fish oil daily (750DHA/250EPA) | Dietary supplement | Omega 3 Supplementation |
| Placebo Soybean OilParticipants will supplement 4g of Soybean oil daily | Dietary supplement | Soybean oil |
Primary outcome
Maternal Fasting and Postprandial Triglycerides
Time frame: 34 weeks gestational age
Differences in maternal fasting and postprandial triglycerides between groups
3 secondary outcomes
Mesenchymal Stem Cell Differentiation
Time frame: Delivery
Placental Nutrient Transport Capacity
Time frame: Delivery
Nutrient Transport Gene expression
Time frame: Delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 29931812Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.
Related trials for Pregnancy
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingObservational study
Study of Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
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.
Teri L Hernandez, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Omega 3 Supplementation in people with Pregnancy, run by University of Colorado, Denver at 2 sites in United States.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maternal Fasting and Postprandial Triglycerides (time frame: 34 weeks gestational age). 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 NCT04349475, which also lists 1 linked publication.
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 31 Aug 2026.