Maternal ObesityEarly Phase 1EPyQNCT06245083
Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes
A Early Phase 1 study testing Pyrroloquinoline quinone (PQQ) in people with Maternal Obesity, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Maternal Obesity
- What is being tested?
- Pyrroloquinoline quinone (PQQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women
- Body mass index >30 kg/m2
- Currently pregnant with gestational age up to 16 wks
Who cannot join
- 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
Show all 11Show fewer
- Thrombophilias
- Substance use
- Human immunodeficiency virus (HIV)
- Hepatitis C
- Autoimmune disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes (EPyQ)
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.
Read the 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
- Being tested
- Pyrroloquinoline quinone (PQQ), Placebo with soybean oil
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrroloquinoline quinone (PQQ)Drug
Oral supplement taken daily
Placebo with soybean oilDrug
Oral supplement taken daily
| Study group | Role | What they receive |
|---|---|---|
| PQQ supplement | Active comparator | Pyrroloquinoline quinone (PQQ) 20 mg/day Receives: Drug: Pyrroloquinoline quinone (PQQ) |
| Placebo | Placebo comparator | Placebo supplement with soybean oil 20 mg/day Receives: Drug: Placebo with soybean oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptin
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
Adiponectin
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
Triglycerides (TGs)
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
High-density lipoprotein cholesterol (HDL-C)
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
Low-density lipoprotein cholesterol (LDL-C)
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
Very-low-density lipoprotein cholesterol (VLDL-C)
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
C-reactive protein (CRP)
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
Soluble CD163 (sCD163)
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
Lipopolysaccharides (LPS)
Measured at multiple time points from maternal blood samples
Measured: 1 month postpartum
Glucose
Measured from routine gestational diabetes screening
Measured: 24-28 weeks
Infant fat mass
Measured using air-displacement plethysmography (PEAPODTM)
Measured: 1-3 days postpartum
Infant fat-free mass
Measured using air-displacement plethysmography (PEAPODTM)
Measured: 1-3 days postpartum
Infant weight
Measured using scale
Measured: 1-3 days postpartum
Infant body length
Measured using measuring tape or board
Measured: 1-3 days postpartum
Infant limb length
Measured using measuring tape or board
Measured: 1-3 days postpartum
Infant head circumference
Measured using measuring tape
Measured: 1-3 days postpartum
Infant abdominal circumference
Measured using measuring tape
Measured: 1-3 days postpartum
Infant chest circumference
Measured using measuring tape
Measured: 1-3 days postpartum
Infant mid-thigh circumference
Measured using measuring tape
Measured: 1-3 days postpartum
Infant mid-arm circumference
Measured using measuring tape
Measured: 1-3 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study startDec 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Investigator did not return submission for final IRB approval. Study was withdrawn by IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal ObesityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to receive either pyrroloquinoline quinone (PQQ) or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marty Maxted, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245083
- Sponsor's protocol ID
- 16843
- Acronym
- EPyQ
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes (EPyQ)
- ClinicalTrials.gov ID
- NCT06245083
- Acronym / sponsor ID
- EPyQ / 16843
- Conditions
- Maternal Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator did not return submission for final IRB approval. Study was withdrawn by IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized to receive either pyrroloquinoline quinone (PQQ) or placebo
| Arm | Type | Receives |
|---|---|---|
| PQQ supplement | Active comparator | Drug: Pyrroloquinoline quinone (PQQ)Pyrroloquinoline quinone (PQQ) 20 mg/day |
| Placebo | Placebo comparator | Drug: Placebo with soybean oilPlacebo supplement with soybean oil 20 mg/day |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult women
- Body mass index >30 kg/m2
- Currently pregnant with gestational age up to 16 wks
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyrroloquinoline quinone (PQQ)Oral supplement taken daily | Drug | PQQ supplement |
| Placebo with soybean oilOral supplement taken daily | Drug | Placebo |
Primary outcome
Leptin
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Adiponectin
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Triglycerides (TGs)
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
High-density lipoprotein cholesterol (HDL-C)
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Low-density lipoprotein cholesterol (LDL-C)
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Very-low-density lipoprotein cholesterol (VLDL-C)
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
C-reactive protein (CRP)
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Soluble CD163 (sCD163)
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Lipopolysaccharides (LPS)
Time frame: 1 month postpartum
Measured at multiple time points from maternal blood samples
Glucose
Time frame: 24-28 weeks
Measured from routine gestational diabetes screening
Infant fat mass
Time frame: 1-3 days postpartum
Measured using air-displacement plethysmography (PEAPODTM)
Infant fat-free mass
Time frame: 1-3 days postpartum
Measured using air-displacement plethysmography (PEAPODTM)
Infant weight
Time frame: 1-3 days postpartum
Measured using scale
Infant body length
Time frame: 1-3 days postpartum
Measured using measuring tape or board
Infant limb length
Time frame: 1-3 days postpartum
Measured using measuring tape or board
Infant head circumference
Time frame: 1-3 days postpartum
Measured using measuring tape
Infant abdominal circumference
Time frame: 1-3 days postpartum
Measured using measuring tape
Infant chest circumference
Time frame: 1-3 days postpartum
Measured using measuring tape
Infant mid-thigh circumference
Time frame: 1-3 days postpartum
Measured using measuring tape
Infant mid-arm circumference
Time frame: 1-3 days postpartum
Measured using measuring tape
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Excessive Gestational Weight Gain, Pregnancy
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Guangzhou Preterm and Term Birth Cohort Study
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET
Prevention of Childhood Obesity, Community Health Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marty Maxted, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pyrroloquinoline quinone (PQQ) in people with Maternal Obesity, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptin (time frame: 1 month postpartum). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.