Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes
- Conditions
- Maternal Obesity
- Interventions
- Drug: Pyrroloquinoline quinone (PQQ)
- Registration Number
- NCT06245083
- Lead Sponsor
- University of Oklahoma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 30
- Adult women
- Body mass index >30 kg/m2
- Currently pregnant with gestational age up to 16 wks
- Women with pregestational diabetes (type 1 or type 2)
- Smokers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo with soybean oil Placebo supplement with soybean oil 20 mg/day PQQ supplement Pyrroloquinoline quinone (PQQ) Pyrroloquinoline quinone (PQQ) 20 mg/day
- Primary Outcome Measures
Name Time Method Triglycerides (TGs) 1 month postpartum Measured at multiple time points from maternal blood samples
Very-low-density lipoprotein cholesterol (VLDL-C) 1 month postpartum Measured at multiple time points from maternal blood samples
Infant fat mass 1-3 days postpartum Measured using air-displacement plethysmography (PEAPODTM)
Soluble CD163 (sCD163) 1 month postpartum Measured at multiple time points from maternal blood samples
Adiponectin 1 month postpartum Measured at multiple time points from maternal blood samples
C-reactive protein (CRP) 1 month postpartum Measured at multiple time points from maternal blood samples
Glucose 24-28 weeks Measured from routine gestational diabetes screening
Leptin 1 month postpartum Measured at multiple time points from maternal blood samples
Low-density lipoprotein cholesterol (LDL-C) 1 month postpartum Measured at multiple time points from maternal blood samples
Lipopolysaccharides (LPS) 1 month postpartum Measured at multiple time points from maternal blood samples
Infant fat-free mass 1-3 days postpartum Measured using air-displacement plethysmography (PEAPODTM)
High-density lipoprotein cholesterol (HDL-C) 1 month postpartum Measured at multiple time points from maternal blood samples
Infant body length 1-3 days postpartum Measured using measuring tape or board
Infant abdominal circumference 1-3 days postpartum Measured using measuring tape
Infant chest circumference 1-3 days postpartum Measured using measuring tape
Infant mid-thigh circumference 1-3 days postpartum Measured using measuring tape
Infant weight 1-3 days postpartum Measured using scale
Infant limb length 1-3 days postpartum Measured using measuring tape or board
Infant head circumference 1-3 days postpartum Measured using measuring tape
Infant mid-arm circumference 1-3 days postpartum Measured using measuring tape
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States