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.

Background/Objectives: Obesity during pregnancy is strongly related to increased insulin resistance, and subsequent development of metabolic syndrome-like disorders, such as glucose intolerance, pre-eclampsia, as well as preterm birth, and cesarean delivery. Nutrition can influence the evolution of glycemic response and may help improve adverse pregnancy outcomes and long-term complications. The main objective of the Nutritional Intervention during Gestation and Offspring Health (NIGOHealth) randomized clinical trial (ClinicalTrials.gov Identifier: NCT02285764) was to investigate the potential effects of a low glycemic index/slow digesting (LGI/SD) carbohydrate product on maternal glycemia (glucose AUC at 27⁺⁰-28⁺⁶ weeks; maternal fasting blood glucose (MFBG) at 34⁺⁰-36⁺⁰ weeks), and neonatal body composition. Methods: Obese pregnant women were randomized: 230 in the intervention group (IG), who consumed two servings of an LGI/SD study product daily from 15 weeks of pregnancy until delivery, and 102 participants in the Standard of Care (SOC) group. Results: When analyzing baseline characteristics, significant differences were found in glucose metabolic parameters with higher values for IG than for the SOC group, compromising the group's comparability. Despite this, a statistical analysis was conducted (intention-to-treat analysis/evaluable cohort): no differences were detected regarding maternal blood glucose AUC at 27⁺⁰-28⁺⁶ weeks, nor for MFBG at 34⁺⁰-36⁺⁰ weeks. Nonetheless, HbA1c (%) at 34⁺⁰-36⁺⁰ weeks was significantly lower in the IG vs. the SOC group (5.26 ± 0.03, 5.31 ± 0.04, p = 0.007) after adjusting for baseline conditions. Conclusion: This result might suggest a potential effect of the intervention on Evaluable participants. However, it should be taken with caution, due to the limitations of the study. More RCTs should be carried out to explore the effects of LGI/SD products on glycemic response in obese pregnant women.