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Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes

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

Status
Withdrawn
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06245083
Acronym
EPyQ
Enrollment
0
Registered
2024-02-07
Start date
2024-12-31
Completion date
2025-08-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Obesity

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.

Interventions

Oral supplement taken daily

DRUGPlacebo with soybean oil

Oral supplement taken daily

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Double-blinded

Intervention model description

Participants are randomized to receive either pyrroloquinoline quinone (PQQ) or placebo

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Leptin1 month postpartumMeasured at multiple time points from maternal blood samples
Adiponectin1 month postpartumMeasured at multiple time points from maternal blood samples
Triglycerides (TGs)1 month postpartumMeasured at multiple time points from maternal blood samples
High-density lipoprotein cholesterol (HDL-C)1 month postpartumMeasured at multiple time points from maternal blood samples
Low-density lipoprotein cholesterol (LDL-C)1 month postpartumMeasured at multiple time points from maternal blood samples
Very-low-density lipoprotein cholesterol (VLDL-C)1 month postpartumMeasured at multiple time points from maternal blood samples
C-reactive protein (CRP)1 month postpartumMeasured at multiple time points from maternal blood samples
Soluble CD163 (sCD163)1 month postpartumMeasured at multiple time points from maternal blood samples
Lipopolysaccharides (LPS)1 month postpartumMeasured at multiple time points from maternal blood samples
Glucose24-28 weeksMeasured from routine gestational diabetes screening
Infant fat mass1-3 days postpartumMeasured using air-displacement plethysmography (PEAPODTM)
Infant fat-free mass1-3 days postpartumMeasured using air-displacement plethysmography (PEAPODTM)
Infant weight1-3 days postpartumMeasured using scale
Infant body length1-3 days postpartumMeasured using measuring tape or board
Infant limb length1-3 days postpartumMeasured using measuring tape or board
Infant head circumference1-3 days postpartumMeasured using measuring tape
Infant abdominal circumference1-3 days postpartumMeasured using measuring tape
Infant chest circumference1-3 days postpartumMeasured using measuring tape
Infant mid-thigh circumference1-3 days postpartumMeasured using measuring tape
Infant mid-arm circumference1-3 days postpartumMeasured using measuring tape

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026