ArticleContemporary clinical trials communications2025
An exploratory, open-label, parallel group, randomised controlled trial evaluating the effect of gene based nutritional intervention in type 2 diabetes: The protocol for NUDGE clinical trial.
Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Coevolution of Human Diet and Gut Microbiome: Implications for Nutrigenomics and Cross-Population Health.International journal of microbiology · 2026Review
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8 authors.
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Abstract
Introduction: Type 2 diabetes mellitus (T2DM) presents significant public health challenges in India, where unique genetic and phenotypic characteristics elevate susceptibility. Recent research highlights the interaction of genetic polymorphisms and dietary factors in T2DM management, forming the basis of personalised nutrition interventions. This study outlines the protocol for NUDGE clinical trial to evaluate the efficacy of gene-based dietary strategies compared to standard recommendations in T2DM management. Methods: The NUDGE trial is an exploratory, open-label, parallel-group, randomised controlled clinical trial conducted across healthcare settings in Chandigarh, India. A total of 300 participants diagnosed with T2DM will be randomised into intervention and control groups. The intervention group will receive personalised diet plans based on genetic polymorphisms ( Discussion: Primary outcomes focus on changes in FBG, while secondary outcomes include weight and blood pressure. Statistical analyses will evaluate gene-diet interactions and adherence to dietary plans. The trial aims to establish evidence for precision nutrition in T2DM by leveraging gene-diet interactions to tailor interventions. Findings will provide insights into the role of personalised nutrition in improving glycemic control. Conclusion: The NUDGE trial seeks to advance precision nutrition in T2DM management, paving the way for individualised dietary recommendations to mitigate disease progression and complications. Ctri reg no: CTRI/2021/09/036121 Clinical Trial Registry of India.
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