Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes (EPyQ)
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Withdrawn
- Sponsor
- University of Oklahoma
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Triglycerides (TGs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
Double-blinded
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult women
- •Body mass index >30 kg/m2
- •Currently pregnant with gestational age up to 16 wks
Exclusion Criteria
- •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
Arms & Interventions
PQQ supplement
Pyrroloquinoline quinone (PQQ) 20 mg/day
Intervention: Pyrroloquinoline quinone (PQQ) (Drug)
Placebo
Placebo supplement with soybean oil 20 mg/day
Intervention: Placebo with soybean oil (Drug)
Outcomes
Primary Outcomes
Triglycerides (TGs)
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Very-low-density lipoprotein cholesterol (VLDL-C)
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Infant fat mass
Time Frame: 1-3 days postpartum
Measured using air-displacement plethysmography (PEAPODTM)
Soluble CD163 (sCD163)
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Adiponectin
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
C-reactive protein (CRP)
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Glucose
Time Frame: 24-28 weeks
Measured from routine gestational diabetes screening
Leptin
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Lipopolysaccharides (LPS)
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Infant fat-free mass
Time Frame: 1-3 days postpartum
Measured using air-displacement plethysmography (PEAPODTM)
High-density lipoprotein cholesterol (HDL-C)
Time Frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Infant body length
Time Frame: 1-3 days postpartum
Measured using measuring tape or board
Infant abdominal circumference
Time Frame: 1-3 days postpartum
Measured using measuring tape
Infant chest circumference
Time Frame: 1-3 days postpartum
Measured using measuring tape
Infant mid-thigh circumference
Time Frame: 1-3 days postpartum
Measured using measuring tape
Infant weight
Time Frame: 1-3 days postpartum
Measured using scale
Infant limb length
Time Frame: 1-3 days postpartum
Measured using measuring tape or board
Infant head circumference
Time Frame: 1-3 days postpartum
Measured using measuring tape
Infant mid-arm circumference
Time Frame: 1-3 days postpartum
Measured using measuring tape
Secondary Outcomes
No secondary outcomes reported