Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes

NCT06245083 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 16843
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Obesity

Outcome Measures

Primary Outcomes (20)

• 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

• 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

• 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

Study Arms (2)

PQQ supplement

ACTIVE COMPARATOR

Pyrroloquinoline quinone (PQQ) 20 mg/day

Drug: Pyrroloquinoline quinone (PQQ)

Placebo

PLACEBO COMPARATOR

Placebo supplement with soybean oil 20 mg/day

Drug: Placebo with soybean oil

Interventions

Pyrroloquinoline quinone (PQQ) DRUG

Oral supplement taken daily

PQQ supplement

Placebo with soybean oil DRUG

Oral supplement taken daily

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only pregnant adult women will be recruited for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult women
• Body mass index \>30 kg/m2
• Currently pregnant with gestational age up to 16 wks

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pregnancy in Obesity

Interventions

PQQ Cofactor; Soybean Oil

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marty Maxted, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 7, 2024
• Study Start: December 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)