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jueves, 31 de julio de 2014
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.
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
1Department of Epidemiology & Preventive Medicine, School of
Public Health & Preventive Medicine, Monash University, The Alfred Centre,
Melbourne, Victoria 3004, Australia.
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.
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
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.
Australia and New Zealand Clinical Trials Register (ANZCTR):