Nutritional Intervention During Gestation and Offspring Health

NIGO Health- Nutritional Intervention During Gestation and Offspring Health

The purpose of this study is to investigate the potential effects of a modified carbohydrate nutritional product for obese pregnant women to reduce maternal glycemia.

Inclusion Criteria:

• Voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy authorization prior to any participation in the study.
• Obese (BMI ≥ 30) as determined by pre-pregnancy BMI.
• ≥18 years of age.
• ≥15+0 but ≤16+6 weeks gestation with a singleton pregnancy.
• Willing to follow supplementation protocol and follow appropriate nutritional guidance and refrain from consuming other caloric nutritional supplements that are not approved by the study staff, if applicable.
• Willing to provide body composition measures on infant at birth.
• Willing to consider additional measures if follow-up studies are conducted.

Exclusion Criteria:

• Adverse maternal and/or fetal medical history which is expected to alter blood glucose regulations.
• Previously diagnosed diabetes, previous gestational diabetes, systemic lupus erythematodes, anti-phospholipid syndrome, known renal disease, treated hypertension, uncontrolled hypothyroidism and/or cancer.
• Taking medications that can impact blood glucose.
• Previous bariatric surgery.
• Lactose intolerant and/or has milk protein allergy or requires a special diet regime.
• Participating in another clinical trial that would impact participation in this study.