Email updates

Keep up to date with the latest news and content from BMC Endocrine Disorders and BioMed Central.

Open Access Highly Accessed Study protocol

Effect of dietary prebiotic supplementation on advanced glycation, insulin resistance and inflammatory biomarkers in adults with pre-diabetes: a study protocol for a double-blind placebo-controlled randomised crossover clinical trial

Nicole J Kellow1*, Melinda T Coughlan23, Gayle S Savige1 and Christopher M Reid1

Author Affiliations

1 Department of Epidemiology & Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, The Alfred Centre, Melbourne, Victoria 3004, Australia

2 Glycation, Nutrition & Metabolism Laboratory, Baker IDI Heart & Diabetes Institute, Melbourne, Victoria 8008, Australia

3 Department of Medicine, Central Clinical School, Monash University, Alfred Medical Research & Education Precinct, Melbourne, Victoria 3004, Australia

For all author emails, please log on.

BMC Endocrine Disorders 2014, 14:55  doi:10.1186/1472-6823-14-55

Published: 10 July 2014

Abstract

Background

Advanced glycation endproducts (AGEs) contribute to the development of vascular complications of diabetes and have been recently implicated in the pathogenesis of diabetes. Since AGEs are generated within foodstuffs upon food processing, it is increasingly recognised that the modern diet is replete with AGEs. AGEs are thought to stimulate chronic low-grade inflammation and promote oxidative stress and have been linked to the development of insulin resistance. Simple therapeutic strategies targeted at attenuating the progression of chronic low-grade inflammation and insulin resistance are urgently required to prevent or slow the development of type 2 diabetes in susceptible individuals. Dietary modulation of the human colonic microbiota has been shown to confer a number of health benefits to the host, but its effect on advanced glycation is unknown. The aim of this article is to describe the methodology of a double-blind placebo-controlled randomised crossover trial designed to determine the effect of 12 week consumption of a prebiotic dietary supplement on the advanced glycation pathway, insulin sensitivity and chronic low-grade inflammation in adults with pre-diabetes.

Methods/Design

Thirty adults with pre-diabetes (Impaired Glucose Tolerance or Impaired Fasting Glucose) aged between 40–60 years will be randomly assigned to receive either 10 grams of prebiotic (inulin/oligofructose) daily or 10 grams placebo (maltodextrin) daily for 12 weeks. After a 2-week washout period, study subjects will crossover to receive the alternative dietary treatment for 12 weeks. The primary outcome is the difference in markers of the advanced glycation pathway carboxymethyllysine (CML) and methylglyoxal (MG) between experimental and control treatments. Secondary outcomes include HbA1c, insulin sensitivity, lipid levels, blood pressure, serum glutathione, adiponectin, IL-6, E-selectin, myeloperoxidase, C-reactive protein, Toll-like Receptor 4 (TLR4), soluble receptor for AGE (sRAGE), urinary 8-isoprostanes, faecal bacterial composition and short chain fatty acid profile. Anthropometric measures including BMI and waist circumference will be collected in addition to comprehensive dietary and lifestyle data.

Discussion

Prebiotics which selectively stimulate the growth of beneficial bacteria in the human colon might offer protection against AGE-related pathology in people at risk of developing type 2 diabetes.

Trial registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12613000130763.

Keywords:
Advanced glycation end products; Maillard reaction; Prebiotics; Gut microbiota; Type 2 diabetes mellitus; Insulin resistance; Inflammation