Summary: In obese pregnant women, a low glycaemic index/slow digesting (LGI/SD) carbohydrate product did not improve the prespecified primary outcomes of maternal glucose AUC at 27-28 weeks or fasting glucose at 34-36 weeks versus standard of care. A small secondary reduction in HbA1c at 34-36 weeks was observed (5.26% vs 5.31%, p=0.007) after adjustment, but baseline groups were not comparable and the trial was manufacturer-funded.
PICO Summary
| Element | Detail |
|---|---|
| Population | 332 obese pregnant women (NIGOHealth RCT, NCT02285764), single-centre, Granada, Spain. |
| Intervention | Two daily servings of an LGI/SD carbohydrate study product from 15 weeks gestation until delivery (intervention group, n=230). |
| Comparison | Standard of care dietary recommendations (SOC group, n=102). |
| Outcome | Primary outcomes NULL: no significant between-group difference in maternal glucose AUC at 27-28 weeks or maternal fasting blood glucose at 34-36 weeks. Secondary outcome: HbA1c at 34-36 weeks lower in the intervention group (5.26 ± 0.03% vs 5.31 ± 0.04%, p=0.007) after baseline adjustment. No CI, ARR, or NNT reported in the abstract; baseline glucose metabolism differed significantly between arms, compromising comparability. |
LGI/SD carbohydrate product in obese pregnancy (NIGOHealth)
RCT · obese pregnancy · 15 wk to delivery
Primary maternal glycaemia outcomes were null. A small adjusted secondary HbA1c difference (5.26% vs 5.31%) is of doubtful clinical relevance in a manufacturer-funded, baseline-imbalanced trial.
Expert Commentary
This randomized trial is best read as a negative study for its primary endpoints. No significant difference was demonstrated for maternal glucose area under the curve at 27 to 28 weeks or for fasting glucose at 34 to 36 weeks, so the headline conclusion must be that the LGI/SD product was not shown to improve maternal glycaemia. The only significant signal was a secondary HbA1c difference of roughly 0.05 percentage points, a magnitude that is statistically detectable but of doubtful clinical relevance and obtained only after statistical adjustment. Interpretation is further constrained because the randomization did not produce balanced arms: baseline glucose parameters were worse in the intervention group, and the analysis leaned on adjusted evaluable-cohort estimates rather than a clean intention-to-treat result. The unequal allocation (230 versus 102) and manufacturer sponsorship, with several authors employed by the product maker, are additional reasons for caution about any positive framing. Can I use this with my patients? Not yet. There is no convincing evidence here that this product lowers clinically meaningful glycaemic outcomes or improves neonatal body composition in obese pregnancy, and the authors themselves call for further trials. Clinicians should continue to rely on established dietary and lifestyle counselling. Future studies should be adequately powered, properly balanced at baseline, independently funded, and report confidence intervals and neonatal outcomes transparently.
References
G Bermúdez M, García-Ricobaraza M, García-Santos JA, 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