Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes

Maternal Obesity Clinical Trial

— EPyQ  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245083
• Other study ID #: 16843
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: University of Oklahoma
• Contact: Marta Maxted, MD
• Phone: 4052715597
• Email: marta-maxted[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Obesity

Intervention

Drug:
• Pyrroloquinoline quinone (PQQ)
Oral supplement taken daily
• Placebo with soybean oil
Oral supplement taken daily

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

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