Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maternal Fasting and Postprandial Triglycerides
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 0 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between the ages of 21-39 yrs
- •Pre-pregnancy BMI 28-39
- •Fasting Triglyceride ≥120 mg/dL measured by 15 wks
排除标准
- •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
研究组 & 干预措施
Omega 3 Supplementation
Supplementation of 4g of DHA/EPA daily
干预措施: Intervention Omega 3 Supplementation (Dietary Supplement)
Soybean oil
Supplementation of 4g Soybean Oil
干预措施: Placebo Soybean Oil (Dietary Supplement)
结局指标
主要结局
Maternal Fasting and Postprandial Triglycerides
时间窗: 34 weeks gestational age
Differences in maternal fasting and postprandial triglycerides between groups
次要结局
- Mesenchymal Stem Cell Differentiation(Delivery)
- Placental Nutrient Transport Capacity(Delivery)
- Nutrient Transport Gene expression(Delivery)