Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes (EPyQ)

University of Oklahoma (OU)

Status and phase: Withdrawn; Early Phase 1

Conditions: Maternal Obesity

Treatments: Drug: Pyrroloquinoline quinone (PQQ); Drug: Placebo with soybean oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06245083

16843

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

PQQ supplement

Active Comparator group

Description:

Pyrroloquinoline quinone (PQQ) 20 mg/day

Treatment:

Drug: Pyrroloquinoline quinone (PQQ)

Placebo

Placebo Comparator group

Description:

Placebo supplement with soybean oil 20 mg/day

Treatment:

Drug: Placebo with soybean oil