None listed
Conditions
Brief summary
Advanced glycation endproducts (AGEs) are formed within the human body as a normal consequence of metabolism, but their formation is accelerated in people with elevated blood glucose levels such as those with diabetes. Excessive AGEs are known to have negative effects within the body including contributing to kidney damage, stimulating inflammation and promoting changes in blood vessels which lead to heart disease. AGEs have been shown to contribute to the development of the complications of diabetes and more recently it has been hypothesised that AGEs may play a major role in the development of type 2 diabetes. Simple therapies aimed at reducing the progression of inflammation and insulin resistance are urgently needed to prevent or slow type 2 diabetes development in susceptible individuals. Dietary supplements (called prebiotics) which promote the growth of beneficial bacteria in the human bowel have been shown to reduce inflammation and improve insulin resistance, but their effect on AGEs is unknown. Taking a daily prebiotic dietary supplement which stimulates the growth of beneficial bacteria in the human bowel might offer protection against AGE-related pathology in people at risk of developing type 2 diabetes. This study aims to determine the effect of 24-week consumption of a prebiotic dietary supplement on tissue AGE (advanced glycation endproduct) levels, insulin resistance and inflammatory biomarkers in adults with pre-diabetes in comparison to those receiving a placebo supplement.
Interventions
10 grams inulin powder taken orally once daily, for 24 weeks
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Individuals diagnosed with prediabetes (Impaired Fasting Glucose or Impaired Glucose Tolerance) within the previous 12 months. Diagnosis will have been made at each individual’s local GP clinic after undertaking an Oral Glucose Tolerance Test. Prediabetes was defined as a fasting plasma glucose concentration greater than or equal to 6.1 and less than 7.0 mmol/L followed by a 2-hour post glucose load glucose concentration less than 7.8 mmol/L, or a fasting plasma glucose less than 7.0 mmol/L followed by a 2-hour post glucose load glucose concentration greater than or equal to 7.8 and less than 11.1 mmol/L.
Exclusion criteria
Individuals previously diagnosed with type 1, type 2 diabetes or impaired renal function, individuals with any gastrointestinal pathology (coeliac disease, inflammatory bowel disease), cigarette smokers, pregnant women, individuals already taking antibiotics or dietary prebiotic or probiotic nutritional supplements, individuals taking aspirin or Vitamin B, individuals who have made major dietary or lifestyle changes in the previous three months, individuals who are unwilling to provide blood, urine and stool samples or are unable to attend their local pathology collection centre.
Outcome results
None listed