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| Name | Class |
|---|---|
| European Union | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement | Experimental | One 237 ml oral supplement consumed two times a day; Not commercially available. |
|
| Standard of Care | Other | As determined by the study site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement | Other | Modified carbohydrate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Oral Glucose Tolerance Test (OGTT) | 2 hour OGTT | 27-28 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Body Composition | Birth - 72 hours | |
| Maternal Fasting Blood Glucose | 34-36 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Oliveros Delgado, BSc, MSc | Abbott Nutrition | Study Chair |
| Ricardo Rueda, MD, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital | München | 80337 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40507210 | Derived | G Bermudez M, Garcia-Ricobaraza M, Garcia-Santos JA, Segura MT, Puertas-Prieto A, Gallo-Vallejo JL, Padilla-Vinuesa C, Koletzko B, Baggs GE, Oliveros E, Rueda R, Campoy C. Effect of a Low Glycemic Index/Slow Digesting (LGI/SD) Carbohydrate Product on Maternal Glycemia and Neonatal Body Composition in Obese Pregnant Women: The NIGOHealth Randomized Clinical Trial. Nutrients. 2025 Jun 5;17(11):1942. doi: 10.3390/nu17111942. |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Standard of Care |
| Other |
As determined by the study site |
|
| University of Granda |
| Granada |
| 11 18071 |
| Spain |
| University Clinical Hospital San Cecilio | Granada | 16 18012 | Spain |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |