Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes (EPyQ)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Triglycerides (TGs)
研究概览
简要总结
Maternal obesity (MO) affects 1 in 5 women and is strongly linked to increased birth weight, childhood/adolescent obesity, life-long metabolic and inflammatory disorders, and childhood neuropsychiatric disorders. There remains a critical unmet need for developing a safe and effective non-pharmacological approach for attenuating metabolic inflammation and ameliorating the adverse effects of MO on offspring health that originate in utero and extend into the lactational period. Pyrroloquinoline quinone (PQQ) is a diet-derived natural food supplement with anti-inflammatory properties that, in humans and mice, improves metabolism and exerts potent immunoregulatory effects. Researchers' central hypothesis is that PQQ administration during MO pregnancy 1) improves maternal metabolic and inflammatory indices, 2) improves utero-placental blood flow and ameliorates placental maladaptation (oxidative stress, hypoxia, inflammation and fatty acid transporter expression) and 3) reduces neonatal adiposity.
详细描述
Women with a body mass index (BMI) greater than 30 will be recruited during their first trimester clinic visit up to 16 weeks of gestation. In addition to the blood draw and anthropometric measurements normally carried out at the first pre-natal visit, researchers will provide consented study subjects with pyrroloquinoline quinone (PQQ) or placebo in capsules at a dose of 20 milligrams per day. There will be 15 women per group. At ~30 days after initiating the study (4-week routine follow-up visit) blood samples will be obtained. At ~24-28 weeks gestation, during the 2nd trimester visit, study subjects will undergo the standard 1-hour oral glucose screen, routine prenatal complete blood count (CBC) evaluation, study maternal blood sampling, and anthropometric measurements. During the delivery inpatient admission, researchers will again collect maternal blood as well as placental tissue, and umbilical cord blood (plasma, aperipheral blood mononuclear cells) after delivery. Placental tissue (samples from four separate cotyledons) will be collected for protein (homogenate and plasma membrane isolation), ribonucleic acid (RNA), quantitative polymerase chain reaction (qPCR), and histology (fixed in 4% paraformaldehyde). The neonate will undergo PeaPod evaluation prior to discharge, and within 72 hours after birth. PQQ supplementation will continue for 30 days post-partum at which time maternal blood and breastmilk samples will be collected, as well as a follow up infant Peapod evaluation and maternal dual x-ray absorptiometry (DEXA) scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women
- •Body mass index >30 kg/m2
- •Currently pregnant with gestational age up to 16 wks
排除标准
- •Women with pregestational diabetes (type 1 or type 2)
- •Women with other risk factors for placental insufficiency or preterm delivery
- •Advanced maternal age (age ≥40 yrs)
- •Pre-existing chronic hypertension
- •Renal disease
- •Thrombophilias
- •Substance use
- •Human immunodeficiency virus (HIV)
- •Hepatitis C
- •Autoimmune disorders
研究组 & 干预措施
PQQ supplement
Pyrroloquinoline quinone (PQQ) 20 mg/day
干预措施: Pyrroloquinoline quinone (PQQ) (Drug)
Placebo
Placebo supplement with soybean oil 20 mg/day
干预措施: Placebo with soybean oil (Drug)
结局指标
主要结局
Triglycerides (TGs)
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Very-low-density lipoprotein cholesterol (VLDL-C)
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Infant fat mass
时间窗: 1-3 days postpartum
Measured using air-displacement plethysmography (PEAPODTM)
Soluble CD163 (sCD163)
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Adiponectin
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
C-reactive protein (CRP)
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Glucose
时间窗: 24-28 weeks
Measured from routine gestational diabetes screening
Leptin
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Low-density lipoprotein cholesterol (LDL-C)
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Lipopolysaccharides (LPS)
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Infant fat-free mass
时间窗: 1-3 days postpartum
Measured using air-displacement plethysmography (PEAPODTM)
High-density lipoprotein cholesterol (HDL-C)
时间窗: 1 month postpartum
Measured at multiple time points from maternal blood samples
Infant body length
时间窗: 1-3 days postpartum
Measured using measuring tape or board
Infant abdominal circumference
时间窗: 1-3 days postpartum
Measured using measuring tape
Infant chest circumference
时间窗: 1-3 days postpartum
Measured using measuring tape
Infant mid-thigh circumference
时间窗: 1-3 days postpartum
Measured using measuring tape
Infant weight
时间窗: 1-3 days postpartum
Measured using scale
Infant limb length
时间窗: 1-3 days postpartum
Measured using measuring tape or board
Infant head circumference
时间窗: 1-3 days postpartum
Measured using measuring tape
Infant mid-arm circumference
时间窗: 1-3 days postpartum
Measured using measuring tape
次要结局
未报告次要终点