Dietary prebiotic supplementation in adults with prediabetes

Not Applicable

• Conditions: Pre-diabetes; Metabolic and Endocrine - Diabetes; type 2 diabetes; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12613000130763
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean skin autofluorescence (which correlates with tissue accumulation of advanced glycation endproducts), measured by an AGE Reader, pre and post intervention.[24 weeks after commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
rinary levels of 8-isoprostanes (corrected for urinary Creatinine)[At baseline and at 24 weeks];HOMA-IR (This is an estimate of an individual's insulin resistance based on their fasting blood glucose and insulin levels)<br>HOMA-IR = Homeostasis Model Assessment - Insulin Resistance[At baseline and at 24 weeks];Serum adiponectin[At baseline and at 24 weeks];Serum myeloperoxidase[At baseline and at 24 weeks];Serum methylglyoxal concentration, as measured by ELISA (enzyme-linked immunosorbent assay) of blood samples.[At baseline and at 24 weeks];Feacal concentration of Branched Chain Fatty acids (proprionate, acetate and butyrate)[At baseline and 24 weeks];Serum lipopolysaccharide (LPS)[Measured at baseline and after 24 weeks];HbA1c (glycated hemoglobin) measured in blood samples[At baseline and 24 weeks]