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Investigator did not return submission for final IRB approval. Study was withdrawn by IRB.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PQQ supplement | Active Comparator | Pyrroloquinoline quinone (PQQ) 20 mg/day |
|
| Placebo | Placebo Comparator | Placebo supplement with soybean oil 20 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrroloquinoline quinone (PQQ) | Drug | Oral supplement taken daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Only pregnant adult women will be recruited for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Marty Maxted, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D000079262 | Pregnancy in Obesity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009765 | Obesity |
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| ID | Term |
|---|---|
| D045542 | PQQ Cofactor |
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Participants are randomized to receive either pyrroloquinoline quinone (PQQ) or placebo
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Double-blinded
| Placebo with soybean oil |
| Drug |
Oral supplement taken daily |
|
| 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 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |