Summary: In a manufacturer-sponsored randomized trial of obese pregnant women (n=332), a low glycemic index/slow digesting (LGI/SD) carbohydrate product did not lower the primary glycemic outcomes (glucose AUC at 27-28 weeks or fasting glucose at 34-36 weeks) versus standard of care. The only significant signal was a small adjusted reduction in HbA1c at 34-36 weeks (5.26% vs 5.31%, p=0.007), which the authors themselves urge interpreting with caution because the groups were not comparable at baseline.
PICO Summary
| Element | Detail |
|---|---|
| Population | 332 obese pregnant women (open-label, parallel-group RCT; Spain; NCT02285764). Note: glucose-metabolism parameters were significantly higher in the intervention group at baseline, compromising group comparability. |
| Intervention | Two daily servings of a low glycemic index/slow digesting (LGI/SD) carbohydrate study product from 15 weeks of gestation until delivery (n=230). |
| Comparison | Standard of care with no LGI/SD product (n=102). |
| Outcome | Primary outcomes NULL: no between-group difference in maternal glucose AUC at 27-28 weeks or in maternal fasting blood glucose at 34-36 weeks (intention-to-treat and evaluable cohort). Only significant finding: adjusted HbA1c at 34-36 weeks lower in the intervention group (5.26% ± 0.03 vs 5.31% ± 0.04, p=0.007). No clinically meaningful neonatal body-composition benefit was demonstrated. No formal effect size, 95% CI, or ARR/NNT for a clinical endpoint reported. |
LGI/SD Carbohydrate Product in Obese Pregnancy (NIGOHealth)
RCT · obese pregnancy · 15 wk to delivery
Negative trial: both primary glycemic endpoints were unchanged. The lone significant result, a 0.05% adjusted HbA1c difference, is biologically trivial and undermined by baseline imbalance and manufacturer sponsorship.
Expert Commentary
This is, in essence, a negative trial. Both prespecified primary glycemic endpoints, the glucose area under the curve at 27 to 28 weeks and fasting glucose at 34 to 36 weeks, were unchanged by the low-glycemic-index product, and no convincing neonatal body-composition benefit was shown. The single statistically significant result, an adjusted HbA1c difference of roughly five hundredths of a percentage point, is biologically trivial and was qualified by the investigators themselves as something to be read with caution. The verdict should be read as no demonstrated efficacy rather than a positive finding. The dominant limitation is that randomization did not yield comparable groups: glucose-metabolism parameters were higher in the intervention arm at baseline, so any adjusted secondary signal rests on statistical correction rather than a clean comparison, and the design was open-label and unbalanced two-to-one. The trial was sponsored by the product manufacturer, with company-affiliated authors, which warrants additional scrutiny of a marginal result. Can I use this with my patients? Not yet. There is no robust evidence that this product improves maternal glycemia or neonatal outcomes in obese pregnancy, and it should not displace established dietary counselling. Adequately powered, blinded, independently funded trials with balanced groups are needed before any such product enters routine antenatal care.
References
G Bermúdez M, García-Ricobaraza M, García-Santos JA, Segura MT, Puertas-Prieto A, Gallo-Vallejo JL, et al. 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;17(11):1942. doi:10.3390/nu17111942