NCT00957476

Omega-3 Supplementation Decreases Inflammation and Fetal Obesity in Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Inflammation
• Obesity
• Pregnancy
• Fetal Growth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 Fish Oil	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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-03-01
• Completion: 2013-06-01
• First posted: 2009-08-12
• Last updated: 2018-05-03

Locations

1 site across 1 country: United States