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.

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 grou

SUBMITTER: Kushwaha S 

PROVIDER: S-EPMC11982480 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature