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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-03-17 DOI:10.1016/j.conctc.2025.101470

Savitesh Kushwaha , Poonam Khanna , Sanjay Kumar Bhadada , Vivek Sagar , Pramod Kumar Gupta , Jarnail Singh Thakur , Madhu Gupta , Rachana Srivastava

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引用次数: 0

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 (TCF7L2 and PPARG), anthropometric, and lifestyle data, while the control group follows standard dietary advice. Baseline and endline assessments will measure fasting blood glucose, HbA1c, anthropometric parameters, and adherence.

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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一项探索性、开放标签、平行组、随机对照试验评估基于基因的营养干预对2型糖尿病的影响：NUDGE临床试验方案

2型糖尿病（T2DM）在印度提出了重大的公共卫生挑战，其独特的遗传和表型特征提高了易感性。最近的研究强调了遗传多态性和饮食因素在2型糖尿病管理中的相互作用，形成了个性化营养干预的基础。本研究概述了NUDGE临床试验的方案，以评估基于基因的饮食策略与标准推荐的饮食策略在T2DM管理中的疗效。方法NUDGE试验是一项探索性、开放标签、平行组、随机对照临床试验，在印度昌迪加尔的医疗机构进行。总共300名确诊为2型糖尿病的参与者将被随机分为干预组和对照组。干预组将接受基于基因多态性（TCF7L2和PPARG）、人体测量和生活方式数据的个性化饮食计划，而对照组则遵循标准饮食建议。基线和终点评估将测量空腹血糖、糖化血红蛋白、人体测量参数和依从性。主要结局关注于FBG的改变，而次要结局包括体重和血压。统计分析将评估基因-饮食的相互作用和对饮食计划的坚持。该试验旨在通过利用基因-饮食相互作用来定制干预措施，为2型糖尿病患者的精确营养提供证据。研究结果将为个性化营养在改善血糖控制方面的作用提供见解。结论：NUDGE试验旨在促进T2DM管理中的精确营养，为个性化饮食建议铺平道路，以减轻疾病进展和并发症。cri reg nocri /2021/09/036121印度临床试验登记处。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.