InflammationNCT00957476
Omega-3 Supplementation Decreases Inflammation and Fetal Obesity in Pregnancy
A study testing Omega-3 Fish Oil in people with Inflammation and Obesity, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity, Pregnancy
- What is being tested?
- Omega-3 Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2013
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI (wt/ht2) > or = 25 at first antenatal visit
- Gestational age at randomization between 8-16 weeks
- No medical problems such as hyperlipidemia, hypertension, or pregestational diabetes
- Between the ages of 18 and 40 years old
- Non-smokers
- No obstetrical problems such as a history of preeclampsia or gestational diabetes
- Confirmed singleton pregnancy
Who cannot join
- Major fetal anomaly
- Regular intake of fish oil supplements (defined as greater than 500 mg per week within the last four weeks). This is due to the placebo group receiving fish oil outside of the study.
- Daily use of nonsteroidal anti-inflammatory agents
- Allergy to fish or fish products, gluten intolerant (because the placebo contains wheat germ oil, which is not gluten free).
- Women who are vegetarians and do not eat any fish.
- Infants born preterm (less than 36 weeks gestation) or less than 2kg.
Show all 27Show fewer
- Heparin use or known thrombophilia (thrombophilias include homozygous for Factor V Leiden).
- Moderate or high titer IgG anticardiolipin antibodies or prolonged activated PTT or other indication of presence of lupus anticoagulant, homozygous for prothrombin gene (G20210A) mutation, antithrombin III deficiency.
- Protein S (low levels outside of pregnancy) or Protein C deficiency.
- Hyperhomocysteinemia (due to safety concerns because n-3 may affect bleeding time).
- Hemophiliacs including von Willebrand's disease (because of safety concerns associated with the hemophilia treatment combined with the n-3 supplements).
- Planned termination of pregnancy.
- Current hypertension or current use of antihypertensive medication (including diuretics), due to increased risk of adverse pregnancy outcome.
- Pregestational diabetes due to increased risks of affecting fetal growth. We will not exclude women who develop GDM during pregnancy but consider a sub-analyses of these women depending on the number of subjects. Known maternal medical complications: cancer (including melanoma but excluding other skin cancers).
- Current hyperthyroidism if not adequately controlled.
- Renal disease with altered renal function (serum creatinine > 1.5).
- Epilepsy or other seizure disorder.
- Systemic lupus (not discoid lupus), scleroderma, polymyalgia rheumatic.
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes).
- Platelet or red blood cell disorder (including idiopathic thrombocytopenia purpura, a history of alloimmune thrombocytopenia in a previous offspring, significant anemia due to hemoglobinopathy but not sickle cell trait. Iron deficiency anemia will NOT be an exclusion as long as the hemoglobin is > 8 gm/dl).
- Chronic pulmonary disease (asthma of any degree of severity is NOT an exclusion).
- Structural, functional or ischemic heart disease. Neither mitral valve prolapse nor paroxysmal supraventricular tachycardia are considered exclusions.
- Known HIV positive with viral load greater than 1,000 copies/ml or CD4 count less than 350/mm3.
- Current or planned cerclage due to interference with the natural cause of delivery.
- Illicit drug or alcohol abuse during current pregnancy.
- At the time of birth, all infants will be evaluated by a pediatrician to make sure that they are healthy. Infants will be excluded from further study if they have any medical problems such as respiratory distress syndrome.
- Infants will also be excluded if they have any problems that exclude them from having estimation of body composition, for e.g. birth weight less than 2 kg.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in pregnancy.
Read the detailed description
In addition to the increase in obesity in adult and children, there has been a significant increase in birth weights over the last 2 decades. Based on our preliminary data, maternal pre-gravid obesity is the strongest risk factor for neonatal as well as adolescent obesity. The long-term goals of our research are to examine therapeutic strategies to decrease fetal adiposity. Obesity and pregnancy are both insulin resistant conditions associated with chronic low-grade inflammation. Therefore, we hypothesize that n-3 PUFA dietary supplements during pregnancy will act as insulin sensitizers decreasing peripheral insulin resistance and inflammation. If correct this mechanism should decrease availability of maternal nutrients to the fetus and subsequently reduce adiposity at birth. We plan a prospective randomized double blind control trial of n-3 PUFA supplementation and placebo in overweight/obese women, with a previous cesarean delivery, initiated in early pregnancy and maintained throughout pregnancy. This proposal has two specific aims. Specific aim 1 is to evaluate the effect of n-3 PUFA supplementation on maternal insulin sensitivity. Measures of maternal insulin sensitivity and lipid metabolism will be made using the ISogtt, indirect calorimetry body composition (BODPOD) and plasma lipid profile at baseline and after dietary intervention.
Specific aim 2 will assess the effect of n-3 PUFA on the inflammatory status in overweight/obese pregnant women. We hypothesize that n-3 PUFA supplementation decreases chronic inflammation during pregnancy by preventing monocyte activation and accumulation of macrophages in WAT thus lowering systemic concentration of pro-inflammatory cytokines. We plan to characterize the longitudinal changes in circulating monocytes and plasma adipokines in order to define the inflammatory patterns in both groups over time. We will also determine the abundance and phenotype of macrophages infiltrating WAT using flow cytometry, immunohistochemistry and gene expression profiling. Furthermore, the role of PPARγ as a central target of n-3 PUFA action to regulate insulin sensitivity will be examined by characterizing the expression of PPARγ in WAT of both supplemented and control groups. Additionally, we will investigate the direct affect of n-3 PUFA on the expression of adiponectin and PPARγ regulated genes in primary cultured adipocytes.
In summary, this proposal combines both clinical and molecular methodologies in an overweight/obese subject population in order to assess the effect of n-3 PUFA on inflammation and insulin resistance. Preliminary data will also be obtained on fetal body composition in order to later address the prevention of the long term adverse effects (developmental programming) of maternal obesity in the developing fetus.
- Conditions
- Inflammation, Obesity, Pregnancy, Fetal Growth
- Being tested
- Omega-3 Fish Oil
- Keywords
- Pregnancy, Metabolic Diseases, Obesity, Fetal adiposity, Omega-3, Inflammation, Insulin Resistance
- Medical subject headings
- Inflammation, Obesity, Metabolic Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fish OilDietary supplement
800mg DHA and 1200mg EPA or the equivalent of a placebo PO (by mouth) once a day from enrollment (prior to 16 weeks gestation) until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fish Oil | Active comparator | 800mg DHA \& 1200mg EPA Receives: Dietary Supplement: Omega-3 Fish Oil |
| Placebo | Placebo comparator | Wheat germ oil Receives: Dietary Supplement: Omega-3 Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased inflammation during human pregnancy
cytokine concentration in plasma, placenta and white adipose tissue
Measured: enrollment (8-16 weeks) to delivery
Secondary outcomes (1)
Reduction of insulin resistance
insulin sensitivity as estimated by OGTT
Measured: enrollment (8-16 weeks) to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Patrick Catalano, MetroHealth Medical Center
- Investigators
- Patrick M Catalano, MD, Principal investigator, MetroHealth Medical CenterSylvie Hauguel-de Mouzon, PhD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957476
- Sponsor's protocol ID
- IRB06-00255
- Other IDs
- R01HD057236
- Status last verified
- May 2018
- First submitted
- 11 Aug 2009
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: when data analysis completed
Publications
Calabuig-Navarro V, Puchowicz M, Glazebrook P, Haghiac M, Minium J, Catalano P, Hauguel deMouzon S, O'Tierney-Ginn P. Effect of omega-3 supplementation on placental lipid metabolism in overweight and obese women. Am J Clin Nutr. 2016 Apr;103(4):1064-72. doi: 10.3945/ajcn.115.124651.
PubMed 26961929Berggren EK, Groh-Wargo S, Presley L, Hauguel-de Mouzon S, Catalano PM. Maternal fat, but not lean, mass is increased among overweight/obese women with excess gestational weight gain. Am J Obstet Gynecol. 2016 Jun;214(6):745.e1-5. doi: 10.1016/j.ajog.2015.12.026. Epub 2015 Dec 21.
PubMed 26719212Haghiac M, Yang XH, Presley L, Smith S, Dettelback S, Minium J, Belury MA, Catalano PM, Hauguel-de Mouzon S. Dietary Omega-3 Fatty Acid Supplementation Reduces Inflammation in Obese Pregnant Women: A Randomized Double-Blind Controlled Clinical Trial. PLoS One. 2015 Sep 4;10(9):e0137309. doi: 10.1371/journal.pone.0137309. eCollection 2015.
PubMed 26340264
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Supplementation Decreases Inflammation and Fetal Obesity in Pregnancy
- ClinicalTrials.gov ID
- NCT00957476
- Acronym / sponsor ID
- IRB06-00255
- Conditions
- Inflammation, Obesity, Pregnancy, Fetal Growth
- Keywords
- Pregnancy, Metabolic Diseases, Obesity, Fetal adiposity, Omega-3, Inflammation, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Aug 2009 (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.
Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in pregnancy.
Detailed description
In addition to the increase in obesity in adult and children, there has been a significant increase in birth weights over the last 2 decades. Based on our preliminary data, maternal pre-gravid obesity is the strongest risk factor for neonatal as well as adolescent obesity. The long-term goals of our research are to examine therapeutic strategies to decrease fetal adiposity. Obesity and pregnancy are both insulin resistant conditions associated with chronic low-grade inflammation. Therefore, we hypothesize that n-3 PUFA dietary supplements during pregnancy will act as insulin sensitizers decreasing peripheral insulin resistance and inflammation. If correct this mechanism should decrease availability of maternal nutrients to the fetus and subsequently reduce adiposity at birth. We plan a prospective randomized double blind control trial of n-3 PUFA supplementation and placebo in overweight/obese women, with a previous cesarean delivery, initiated in early pregnancy and maintained throughout pregnancy. This proposal has two specific aims. Specific aim 1 is to evaluate the effect of n-3 PUFA supplementation on maternal insulin sensitivity. Measures of maternal insulin sensitivity and lipid metabolism will be made using the ISogtt, indirect calorimetry body composition (BODPOD) and plasma lipid profile at baseline and after dietary intervention.
Specific aim 2 will assess the effect of n-3 PUFA on the inflammatory status in overweight/obese pregnant women. We hypothesize that n-3 PUFA supplementation decreases chronic inflammation during pregnancy by preventing monocyte activation and accumulation of macrophages in WAT thus lowering systemic concentration of pro-inflammatory cytokines. We plan to characterize the longitudinal changes in circulating monocytes and plasma adipokines in order to define the inflammatory patterns in both groups over time. We will also determine the abundance and phenotype of macrophages infiltrating WAT using flow cytometry, immunohistochemistry and gene expression profiling. Furthermore, the role of PPARγ as a central target of n-3 PUFA action to regulate insulin sensitivity will be examined by characterizing the expression of PPARγ in WAT of both supplemented and control groups. Additionally, we will investigate the direct affect of n-3 PUFA on the expression of adiponectin and PPARγ regulated genes in primary cultured adipocytes.
In summary, this proposal combines both clinical and molecular methodologies in an overweight/obese subject population in order to assess the effect of n-3 PUFA on inflammation and insulin resistance. Preliminary data will also be obtained on fetal body composition in order to later address the prevention of the long term adverse effects (developmental programming) of maternal obesity in the developing fetus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Fish Oil | Active comparator | Dietary Supplement: Omega-3 Fish Oil800mg DHA \& 1200mg EPA |
| Placebo | Placebo comparator | Dietary Supplement: Omega-3 Fish OilWheat germ oil |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI (wt/ht2) > or = 25 at first antenatal visit
- Gestational age at randomization between 8-16 weeks
- No medical problems such as hyperlipidemia, hypertension, or pregestational diabetes
- Between the ages of 18 and 40 years old
- Non-smokers
Key exclusion criteria (27 listed)
- Major fetal anomaly
- Regular intake of fish oil supplements (defined as greater than 500 mg per week within the last four weeks). This is due to the placebo group receiving fish oil outside of the study.
- Daily use of nonsteroidal anti-inflammatory agents
- Allergy to fish or fish products, gluten intolerant (because the placebo contains wheat germ oil, which is not gluten free).
- Women who are vegetarians and do not eat any fish.
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 |
|---|---|---|
| Omega-3 Fish Oil800mg DHA and 1200mg EPA or the equivalent of a placebo PO (by mouth) once a day from enrollment (prior to 16 weeks gestation) until delivery. | Dietary supplement | Omega-3 Fish Oil, Placebo |
Primary outcome
Decreased inflammation during human pregnancy
Time frame: enrollment (8-16 weeks) to delivery
cytokine concentration in plasma, placenta and white adipose tissue
1 secondary outcome
Reduction of insulin resistance
Time frame: enrollment (8-16 weeks) to 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 3 May 2018.
- Derived from this study: PubMed 26961929Calabuig-Navarro V, Puchowicz M, Glazebrook P, Haghiac M, Minium J, Catalano P, Hauguel deMouzon S, O'Tierney-Ginn P. Effect of omega-3 supplementation on placental lipid metabolism in overweight and obese women. Am J Clin Nutr. 2016 Apr;103(4):1064-72. doi: 10.3945/ajcn.115.124651.
- Derived from this study: PubMed 26719212Berggren EK, Groh-Wargo S, Presley L, Hauguel-de Mouzon S, Catalano PM. Maternal fat, but not lean, mass is increased among overweight/obese women with excess gestational weight gain. Am J Obstet Gynecol. 2016 Jun;214(6):745.e1-5. doi: 10.1016/j.ajog.2015.12.026. Epub 2015 Dec 21.
- Derived from this study: PubMed 26340264Haghiac M, Yang XH, Presley L, Smith S, Dettelback S, Minium J, Belury MA, Catalano PM, Hauguel-de Mouzon S. Dietary Omega-3 Fatty Acid Supplementation Reduces Inflammation in Obese Pregnant Women: A Randomized Double-Blind Controlled Clinical Trial. PLoS One. 2015 Sep 4;10(9):e0137309. doi: 10.1371/journal.pone.0137309. eCollection 2015.
- Individual participant dataSharing planned: Yes. when data analysis completed
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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.
Patrick M Catalano, MD principal investigator
MetroHealth Medical Center
Sylvie Hauguel-de Mouzon, PhD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fish Oil in people with Inflammation and Obesity, run by MetroHealth Medical Center at 1 site 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 7 inclusion and 27 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 3 May 2018. 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 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?
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?
Decreased inflammation during human pregnancy (time frame: enrollment (8-16 weeks) to 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 NCT00957476, which also lists 3 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 3 May 2018.