Trial registered on ANZCTR


Trial ID
ACTRN12613000130763
Ethics application status
Approved
Date submitted
1/02/2013
Date registered
4/02/2013
Date last updated
6/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary prebiotic supplementation in adults with prediabetes
Scientific title
Efficacy of dietary prebiotic supplementation versus maltodextrin on advanced glycation, insulin resistance and inflammatory biomarkers in adults with pre-diabetes
Secondary ID [1] 281880 0
Nil known
Universal Trial Number (UTN)
U1111-1139-1544
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 288268 0
type 2 diabetes 288269 0
Condition category
Condition code
Metabolic and Endocrine 288621 288621 0 0
Diabetes
Diet and Nutrition 288626 288626 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 grams inulin powder taken orally once daily, for 24 weeks
Intervention code [1] 286443 0
Prevention
Intervention code [2] 286446 0
Treatment: Other
Comparator / control treatment
3.7 grams maltodextrin powder taken orally once daily, for 24 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 288774 0
mean skin autofluorescence (which correlates with tissue accumulation of advanced glycation endproducts), measured by an AGE Reader, pre and post intervention.
Timepoint [1] 288774 0
24 weeks after commencement of intervention
Secondary outcome [1] 300942 0
Urinary levels of 8-isoprostanes (corrected for urinary Creatinine)
Timepoint [1] 300942 0
At baseline and at 24 weeks
Secondary outcome [2] 300943 0
HOMA-IR (This is an estimate of an individual's insulin resistance based on their fasting blood glucose and insulin levels)
HOMA-IR = Homeostasis Model Assessment - Insulin Resistance
Timepoint [2] 300943 0
At baseline and at 24 weeks
Secondary outcome [3] 300944 0
Serum adiponectin
Timepoint [3] 300944 0
At baseline and at 24 weeks
Secondary outcome [4] 300945 0
Serum myeloperoxidase
Timepoint [4] 300945 0
At baseline and at 24 weeks
Secondary outcome [5] 300946 0
Serum methylglyoxal concentration, as measured by ELISA (enzyme-linked immunosorbent assay) of blood samples.
Timepoint [5] 300946 0
At baseline and at 24 weeks
Secondary outcome [6] 300947 0
Feacal concentration of Branched Chain Fatty acids (proprionate, acetate and butyrate)
Timepoint [6] 300947 0
At baseline and 24 weeks
Secondary outcome [7] 300948 0
Serum lipopolysaccharide (LPS)
Timepoint [7] 300948 0
Measured at baseline and after 24 weeks
Secondary outcome [8] 300957 0
HbA1c (glycated hemoglobin) measured in blood samples
Timepoint [8] 300957 0
At baseline and 24 weeks

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Doctors at local general practice clinics will provide all patients fulfilling the inclusion criteria with information about the study. Patients who are interested in undergoing further assessment for eligibility will contact one of the researchers by telephone, who will determine whether inclusion/exclusion criteria are met and provide further information about the trial. Potential trial participants will attend the general practice clinics to sign paperwork and undergo initial assessment by this researcher. At this time the participant will select an envelope from a collection of 40 sealed, opaque envelopes which details the participant's treatment allocation. The researcher will make a note of the treatment allocation and will ensure that each participant receives supplies of their correct treatment or placebo. This researcher will then have no further involvement in the collection of results or data analysis of this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
When 40 participants have been recruited, the order that each participant attends the general practice clinic for initial assessment and treatment allocation will be determined using random number generation (Microsoft Excel)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will be performed. Data will be presented as means +/- SD. The Kolmogorov-Smirnov goodness-of-fit test will be used to test for normal distribution. Differences of means between groups will be analysed by the Student t-test or the non-parametric equivalent. Correlation analyses will be performed using the Pearson correlation coefficient. Significance of changes during the study will be assessed by comparing 1) change of means between baseline and end of study within each group by paired t test, 2) percentage of change from baseline to the end of the study between the intervention and the control groups by the Mann-Whitney U test, and 3) differences between the means of both groups at the end of the study by unpaired t test. Significant differences will be defined as a value of P<0.05 based on two-sided tests. Effect sizes including 95% confidence intervals will be calculated for all significant outcomes. Data analysis will be performed using SPSS 20.0 software (SPSS, Chicago, IL).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6265 0
3995 - Wonthaggi
Recruitment postcode(s) [2] 6266 0
3953 - Leongatha
Recruitment postcode(s) [3] 6267 0
3950 - Korumburra
Recruitment postcode(s) [4] 6268 0
3960 - Foster

Funding & Sponsors
Funding source category [1] 286665 0
University
Name [1] 286665 0
Monash University
Address [1] 286665 0
Department of Rural & Indigenous Health
PO Box 973
Moe
Victoria 3825
Country [1] 286665 0
Australia
Funding source category [2] 286666 0
Government body
Name [2] 286666 0
National Health & Medical Research Council
Address [2] 286666 0
GPO Box 1421
Canberra
ACT 2601
Country [2] 286666 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Rural & Indigenous Health
PO Box 973
Moe
Victoria 3825
Country
Australia
Secondary sponsor category [1] 285443 0
None
Name [1] 285443 0
None
Address [1] 285443 0
Country [1] 285443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288734 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 288734 0
Monash University
Clayton Campus
Wellington Road
Clayton
Victoria 3800
Ethics committee country [1] 288734 0
Australia
Date submitted for ethics approval [1] 288734 0
Approval date [1] 288734 0
16/01/2013
Ethics approval number [1] 288734 0
CF12/2690 - 2012001452: Dietary prebiotic supplementation in adults with prediabetes

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37554 0
Dr Gayle Savige
Address 37554 0
Monash University Department of Rural Health
PO Box 973, Moe, Victoria 3825
Country 37554 0
Australia
Phone 37554 0
+61 3 5128 1027
Fax 37554 0
+61 3 5128 1080
Email 37554 0
gayle.savige@monash.edu
Contact person for public queries
Name 37555 0
Dr Gayle Savige
Address 37555 0
Monash University Department of Rural Health
PO Box 973, Moe, Victoria 3825
Country 37555 0
Australia
Phone 37555 0
+61 3 5128 1027
Fax 37555 0
+61 3 5128 1080
Email 37555 0
gayle.savige@monash.edu
Contact person for scientific queries
Name 37556 0
Mrs Nicole Kellow
Address 37556 0
Monash University Department of Rural Health
PO Box 973, Moe, Victoria 3825
Country 37556 0
Australia
Phone 37556 0
+61 (0)488 488 808
Fax 37556 0
+61 3 5128 1080
Email 37556 0
nicole.kellow@monash.edu