Effects of an isoenergetic low Glycaemic Index (GI) diet on liver fat accumulation and gut microbiota composition in patients with non-alcoholic fatty liver disease (NAFLD): a study protocol of an efficacy mechanism evaluation

Amina Al-Awadi; Jane Grove; Moira Taylor; Ana Valdes; Amrita Vijay; Stephen Bawden; Penny Gowland; Guruprasad Aithal

doi:10.1136/bmjopen-2020-045802

Effects of an isoenergetic low Glycaemic Index (GI) diet on liver fat accumulation and gut microbiota composition in patients with non-alcoholic fatty liver disease (NAFLD): a study protocol of an efficacy mechanism evaluation

BMJ Open. 2021 Oct 7;11(10):e045802. doi: 10.1136/bmjopen-2020-045802.

Authors

Amina Al-Awadi^{1

2

3}, Jane Grove^{1

2}, Moira Taylor⁴, Ana Valdes^{2

5}, Amrita Vijay⁵, Stephen Bawden^{2

6}, Penny Gowland^{2

6}, Guruprasad Aithal^{7

2}

Affiliations

¹ Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.
² National Institute of Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.
³ Al-Sabah Hospital, Ministry of Health, Civil Service Commission, Kuwait City, Kuwait.
⁴ School of Life Sciences, University of Nottingham, Nottingham, UK.
⁵ School of Medicine, University of Nottingham, Nottingham, UK.
⁶ Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, UK.
⁷ Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK mszag3@exmail.nottingham.ac.uk.

Abstract

Introduction: A Low Glycaemic Index (LGI) diet is a proposed lifestyle intervention in non-alcoholic fatty liver diseases (NAFLD) which is designed to reduce circulating blood glucose levels, hepatic glucose influx, insulin resistance and de novo lipogenesis. A significant reduction in liver fat content through following a 1-week LGI diet has been reported in healthy volunteers. Changes in dietary fat and carbohydrates have also been shown to alter gut microbiota composition and lead to hepatic steatosis through the gut-liver axis. There are no available trials examining the effects of an LGI diet on liver fat accumulation in patients with NAFLD; nor has the impact of consuming an LGI diet on gut microbiota composition been studied in this population. The aim of this trial is to investigate the effects of LGI diet consumption on liver fat content and its effects on gut microbiota composition in participants with NAFLD compared with a High Glycaemic Index (HGI) control diet.

Methods and analysis: A 2×2 cross-over randomised mechanistic dietary trial will allocate 16 participants with NAFLD to a 2-week either HGI or LGI diet followed by a 4-week wash-out period and then the LGI or HGI diet, alternative to that followed in the first 2 weeks. Baseline and postintervention (four visits) outcome measures will be collected to assess liver fat content (using MRI/S and controlled attenuation parameter-FibroScan), gut microbiota composition (using 16S RNA analysis) and blood biomarkers including glycaemic, insulinaemic, liver, lipid and haematological profiles, gut hormones levels and short-chain fatty acids.

Ethics and dissemination: Study protocol has been approved by the ethics committees of The University of Nottingham and East Midlands Nottingham-2 Research Ethics Committee (REC reference 19/EM/0291). Data from this trial will be used as part of a Philosophy Doctorate thesis. Publications will be in peer-reviewed journals.

Trial registration number: NCT04415632.

Keywords: hepatobiliary disease; hepatology; nutrition & dietetics.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Diet
Gastrointestinal Microbiome*
Glycemic Index
Humans
Liver
Non-alcoholic Fatty Liver Disease*
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT04415632