Gut microbiome predicts personalized responses to dietary fiber in prediabetes: a randomized, open-label trial

Gut microbiota contributes to prediabetes progression, however, whether microbiota features can guide targeted prevention and treatment for diabetes requires validation through large-scale clinical trials. Here, in a randomized, open-label trial, we randomly assigned 802 prediabetic subjects to a usual care control group (patient education and dietary recommendations, n = 393) or a dietary fiber intervention group (n = 409) for 6 months. The primary outcome was the percentage change in whole-blood HbA1c, and secondary outcomes were the changes in other glucose, insulin, lipid, liver and kidney function, and anthropometric parameters. There were no statistically significant differences in the primary and secondary outcomes between groups. In post-hoc analysis, we reclassified subjects into four clusters using a multivariate clustering model based on age, BMI, HbA1c, HOMA2-IR and HOMA2-B. These clusters differed in metabolic status, risks of diabetes and its complications, gut microbiome and serum metabolites. Notably, dietary fiber improved glycemic control in Clusters 3 and 4, but not in Clusters 1 and 2, consistent with observed gut microbiota alleviations. By using a LightGBM machine learning model, we calculated a microbiome-based clinical decision score to predict personalized fiber intervention responses and identified individuals who can get glycemic benefits. In conclusion, our study suggests that the gut microbiota response influences the effectiveness of dietary fiber intervention and provides a clinically applicable model to guide microbiome-targeted personalized medicine for prediabetes. Clinical Trial Registry: ChiCTR1900027663.

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Journal
Nature Communications
Published
2025-12-13
DOI
https://doi.org/10.1038/s41467-025-66498-x
Citations
3
Primary Topic
Gut microbiota and health
Type
article
Field-Weighted Citation Impact
2.42

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article

Gut microbiome predicts personalized responses to dietary fiber in prediabetes: a randomized, open-label trial

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3 citations
Nature Communications
Gut microbiota and health
2.42
article

Gut microbiome predicts personalized responses to dietary fiber in prediabetes: a randomized, open-label trial

Delei Song, Chaoxun Wang, Chenhong Zhang, Jixiong Xu, Yongde Peng, Suijun Wang, Xiaoying Ding, Rui Zhai, Huimin Zhou, Yuhang Ma, Shasha He, Aimin Huang, Quanquan Gu, Liping Chu, Nengguang Fan, Chunfang Qian, Bo Feng, Xiaofeng Li, Li Li, Hao Zhang, Hua Wang, Jiao Wang, Yan Zhang, Weiping Dong, Xuejiao Wang, Yin Zhu, Jian Teng, Guangli Feng, Yue Li, Yu Shi, Jian Fan, Xueli Zhang, Yanping Wang, Enfang Fan, Meihua Wu
article en
3 citations

Abstract

Gut microbiota contributes to prediabetes progression, however, whether microbiota features can guide targeted prevention and treatment for diabetes requires validation through large-scale clinical trials. Here, in a randomized, open-label trial, we randomly assigned 802 prediabetic subjects to a usual care control group (patient education and dietary recommendations, n = 393) or a dietary fiber intervention group (n = 409) for 6 months. The primary outcome was the percentage change in whole-blood HbA1c, and secondary outcomes were the changes in other glucose, insulin, lipid, liver and kidney function, and anthropometric parameters. There were no statistically significant differences in the primary and secondary outcomes between groups. In post-hoc analysis, we reclassified subjects into four clusters using a multivariate clustering model based on age, BMI, HbA1c, HOMA2-IR and HOMA2-B. These clusters differed in metabolic status, risks of diabetes and its complications, gut microbiome and serum metabolites. Notably, dietary fiber improved glycemic control in Clusters 3 and 4, but not in Clusters 1 and 2, consistent with observed gut microbiota alleviations. By using a LightGBM machine learning model, we calculated a microbiome-based clinical decision score to predict personalized fiber intervention responses and identified individuals who can get glycemic benefits. In conclusion, our study suggests that the gut microbiota response influences the effectiveness of dietary fiber intervention and provides a clinically applicable model to guide microbiome-targeted personalized medicine for prediabetes. Clinical Trial Registry: ChiCTR1900027663.

Nature CommunicationsVol. 16(1)
Ningbo University (CN), Nanchang University (CN), University of Shanghai for Science and Technology (CN), The University of Queensland (AU), Shanghai Jiao Tong University (CN), Fudan University (CN), Pudong Medical Center (CN), Shanghai East Hospital (CN), Shanghai Chengtou (China) (CN), Agriculture and Food (AU), Qidong Liver Cancer Prevention Research (CN), Community Health Center (US), First Affiliated Hospital of Nanchang University (CN), Ningbo First Hospital (CN)
National Natural Science Foundation of China, Shanghai Jiao Tong University, Shanghai Hospital Development Center, School of Medicine, Shanghai Jiao Tong University
Openalex Percentile: Top 10%
Gut microbiota and health
2.42
DOIOpen Access PDFOpenAlex
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