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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00422253




Registration number
NCT00422253
Ethics application status
Date submitted
11/01/2007
Date registered
15/01/2007
Date last updated
16/12/2013

Titles & IDs
Public title
Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans
Scientific title
Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans
Secondary ID [1] 0 0
36/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Insulin Resistance 0 0
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - dietary intervention

Behaviour: dietary intervention
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- weight stable overweight and obese (BMI = 25kg/m2) non-diabetic individuals, aged
18-50 years and healthy according to medical history, blood biochemistry and physical
examination.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participants will be excluded if they:

- are aged <18 years or > 50 years;

- currently smoke, have high alcohol use; or a positive urine drug screening test;

- have a history of: diabetes, cardiovascular and hematological disease,
respiratory, gastrointestinal, endocrine, renal or central nervous system
disease, psychosis or psychiatric disorder, active cancer within last 5 years.

- are actively seeking to lose weight, or if their weight has changed by more than
10 kilograms in the previous 12 months.

- have been taking medication within one month prior to commencing the study;

- have acute inflammation (by history, physical or laboratory examination)

- are on hormonal contraceptives, or pregnant (by HCG urine pregnancy screening
test) or lactating

- have highly unusual dietary habits or follow vegan diets (because of the
difficulty in complying with the assigned diet).

- have current diabetes (determined by history and/or 75g glucose OGTT)

- are unable to provide informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart Research Insitute - Melbourne
Recruitment postcode(s) [1] 0 0
3186 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
We hypothesize that reduction in dietary advance glycation endproducts (AGE) intake will
increase insulin sensitivity and normalise insulin secretion in overweight and obese
individuals through reduction of chronic low grade inflammation.

We propose to test this hypothesis by performing euglycemic hypeinsulinemic glucose clamp and
intravenous glucose tolerance test before and after low AGE diet and normal Australian diet
in a cross-over design. This study will provide information relevant to the development and
prevention of type 2 diabetes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00422253
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbora de Courten, MD PhD
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries