Nutritional Intervention During Gestation and Offspring Health
Status
Completed
Conditions
Maternal Glycemia
Treatments
Other: Standard of Care
Other: Nutritional Supplement
Details and patient eligibility
About
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.
Enrollment
331 patients
Sex
Female
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
331 participants in 2 patient groups
Nutritional Supplement
Experimental group
Description:
One 237 ml oral supplement consumed two times a day; Not commercially available.
Treatment:
Other: Nutritional Supplement
Standard of Care
Other group
Description:
As determined by the study site
Treatment:
Other: Standard of Care
Trial contacts and locations
3
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems