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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the natural supplement Pyrroloquinoline Quinone (PQQ) might benefit pregnant women with obesity. Researchers aim to determine if PQQ can improve health markers for mothers and babies, such as reducing inflammation and enhancing blood flow to the placenta. The trial will compare the effects of PQQ to a placebo (a sugar pill with no active ingredients) to assess its efficacy. Pregnant women with a body mass index (BMI) over 30 and who are less than 16 weeks along may be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding PQQ's effects in people, offering participants a chance to contribute to groundbreaking insights.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Pyrroloquinoline Quinone (PQQ) is likely to be safe for humans?

Research has shown that Pyrroloquinoline Quinone (PQQ) might be a safe treatment option. Some studies suggest that PQQ could assist those dealing with obesity during pregnancy. It has been found to protect against inflammation and fat buildup linked to obesity.

PQQ is a natural supplement and is usually well-tolerated, with earlier studies showing no major side effects. This makes it a potentially safe choice for improving metabolism and reducing inflammation. However, this trial is in its early stages, focusing mainly on gathering more safety information. Prospective participants may find these early findings promising. Always consult a healthcare provider to determine the best course of action. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for maternal obesity?

Pyrroloquinoline Quinone (PQQ) is unique because it introduces a new active ingredient that isn't typically used in treating maternal obesity. While standard treatments often involve lifestyle changes, medications, or surgical options, PQQ stands out by potentially boosting metabolic health through its antioxidant properties. Researchers are excited because PQQ might enhance energy production in cells, offering a novel approach to managing obesity that could complement existing treatments.

What evidence suggests that Pyrroloquinoline Quinone (PQQ) might be an effective treatment for maternal obesity?

Research has shown that Pyrroloquinoline Quinone (PQQ) might address health issues related to maternal obesity. Studies have found that PQQ can reduce inflammation and improve metabolism, major concerns in maternal obesity. It also protects against fat buildup and inflammation that can lead to liver problems. Additionally, PQQ may improve cholesterol and fat levels, important for overall health. This trial will compare the effects of PQQ supplementation with a placebo to evaluate its potential benefits for the health of mothers and their babies. ^{1 4 5 6 7}

Who Is on the Research Team?

Marty Maxted, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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

Smokers

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

I am 40 years old or older.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. research.ouhsc.edu research.ouhsc.edu/researchers-earn-23-million-grant-to-study-generational-cycle-of-maternal-obesity-liver-disease

OU Health Sciences Center - Vice President for Research “The mother may still have a high body mass index, but PQQ appears able to lower inflammation and improve cholesterol and lipid levels. If we ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06245083

Evaluating Pyrroloquinoline Quinone (PQQ) for Improving ... Researchers' central hypothesis is that PQQ administration during MO pregnancy 1) improves maternal metabolic and inflammatory indices, 2) improves utero- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10196175/

Pyrroloquinoline-quinone to reduce fat accumulation and ... PQQ showed protective effects on lipotoxicity and inflammation caused by maternal obesity, and intervention on the risk of NAFLD (Jonscher et al., 2017) and ...

4. academic.oup.com academic.oup.com/biolreprod/advance-article/doi/10.1093/biolre/ioaf185/8234311

role for the antioxidants coenzyme Q10 and pyrroloquinoline ... Summary Sentence Preclinical studies suggest that CoQ10 and PQQ may mitigate obesity-related comorbidities affecting fertility and pregnancy, highlighting.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5831029/

Pyrroloquinoline quinone prevents developmental ... Our study shows that maternal obesity/diet causes critical dysbiosis of early gut microbiota during weaning that is associated with programmed dysregulation in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9181499/

Maternal Pyrroloquinoline Quinone Supplementation ... Our findings suggest that PQQ supplementation during gestation and lactation augments pathways involved in the biosynthesis of long-chain fatty acids.

7. frontiersin.org frontiersin.org/journals/molecular-biosciences/articles/10.3389/fmolb.2023.1200025/full

Pyrroloquinoline-quinone to reduce fat accumulation and ... PQQ showed protective effects on lipotoxicity and inflammation caused by maternal obesity, and intervention on the risk of NAFLD (Jonscher et al., 2017) and ...