Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes

NCT ID: NCT06245083

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-08-31

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.

Conditions

Maternal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PQQ supplement

Pyrroloquinoline quinone (PQQ) 20 mg/day

Group Type: ACTIVE_COMPARATOR

Pyrroloquinoline quinone (PQQ)

Intervention Type: DRUG

Oral supplement taken daily

Placebo

Placebo supplement with soybean oil 20 mg/day

Group Type: PLACEBO_COMPARATOR

Placebo with soybean oil

Intervention Type: DRUG

Oral supplement taken daily

Interventions

Pyrroloquinoline quinone (PQQ)

Oral supplement taken daily

Intervention Type: DRUG

Placebo with soybean oil

Oral supplement taken daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marty Maxted, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

16843

Identifier Type: -

Identifier Source: org_study_id