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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Maternal Obesity
• Intervention / Treatment: Drug: Pyrroloquinoline quinone (PQQ); Drug: Placebo with soybean oil

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 Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PQQ supplement; Pyrroloquinoline quinone (PQQ) 20 mg/day	Drug: Pyrroloquinoline quinone (PQQ); Oral supplement taken daily
Placebo Comparator: Placebo; Placebo supplement with soybean oil 20 mg/day	Drug: Placebo with soybean oil; Oral supplement taken daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leptin	Measured at multiple time points from maternal blood samples	1 month postpartum
Adiponectin	Measured at multiple time points from maternal blood samples	1 month postpartum
Glucose	Measured from routine gestational diabetes screening	24-28 weeks
Infant fat mass	Measured using air-displacement plethysmography (PEAPODTM)	1-3 days postpartum
Infant fat-free mass	Measured using air-displacement plethysmography (PEAPODTM)	1-3 days postpartum
Infant weight	Measured using scale	1-3 days postpartum
Infant body length	Measured using measuring tape or board	1-3 days postpartum
Infant limb length	Measured using measuring tape or board	1-3 days postpartum
Infant head circumference	Measured using measuring tape	1-3 days postpartum
Infant abdominal circumference	Measured using measuring tape	1-3 days postpartum
Infant chest circumference	Measured using measuring tape	1-3 days postpartum
Infant mid-thigh circumference	Measured using measuring tape	1-3 days postpartum
Infant mid-arm circumference	Measured using measuring tape	1-3 days postpartum
Triglycerides (TGs)	Measured at multiple time points from maternal blood samples	1 month postpartum
High-density lipoprotein cholesterol (HDL-C)	Measured at multiple time points from maternal blood samples	1 month postpartum
Low-density lipoprotein cholesterol (LDL-C)	Measured at multiple time points from maternal blood samples	1 month postpartum
Very-low-density lipoprotein cholesterol (VLDL-C)	Measured at multiple time points from maternal blood samples	1 month postpartum
C-reactive protein (CRP)	Measured at multiple time points from maternal blood samples	1 month postpartum
Soluble CD163 (sCD163)	Measured at multiple time points from maternal blood samples	1 month postpartum
Lipopolysaccharides (LPS)	Measured at multiple time points from maternal blood samples	1 month postpartum

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Marty Maxted, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Pregnancy Complications; Overweight; Obesity; Obesity, Maternal
• Other Study ID Numbers: 16843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes