PQQ for Maternal Obesity

(EPyQ Trial)

Overseen By Marta Maxted, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Disqualifiers: Diabetes, Hypertension, Renal disease, others

Compensation: Varies

Number of Visits: 2

Duration: Approximately 8 months

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marty Maxted, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for pregnant women dealing with obesity. It aims to explore a non-drug approach to reduce inflammation and improve metabolism during pregnancy, which may benefit both the mother's health and the child's development.

Inclusion Criteria

BMI >30 kg/m2

Currently pregnant with gestational age up to 16 weeks

I am an adult woman.

Exclusion Criteria

I am a woman with diabetes that I had before getting pregnant.

Smokers

Women with other risk factors for placental insufficiency or preterm delivery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive PQQ or placebo from the first trimester up to 30 days postpartum

Approximately 8 months

Multiple visits (in-person) at prenatal check-ups and delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including maternal blood and breastmilk samples, and infant evaluations

1 month postpartum

1 visit (in-person) for follow-up evaluations

Postpartum Monitoring

Continued monitoring of maternal and infant health outcomes, including blood samples and infant measurements

1 month postpartum

Treatment Details

Interventions

• Pyrroloquinoline Quinone (PQQ)

Trial Overview Researchers are testing Pyrroloquinoline Quinone (PQQ), a natural supplement thought to have anti-inflammatory effects, against a placebo containing soybean oil. The goal is to see if PQQ can positively impact maternal health and reduce baby fat levels.

Participant Groups

Group I: PQQ supplement Active Control 1 Intervention

Pyrroloquinoline quinone (PQQ) 20 mg/day

Group II: Placebo Placebo Group 1 Intervention

Placebo supplement with soybean oil 20 mg/day

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+