Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans

Obesity Clinical Trial

Official title:

Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422253
• Other study ID #: 36/06
• Status: Completed
• Phase: N/A
• First received: January 11, 2007
• Last updated: December 12, 2013
• Start date: November 2006
• Est. completion date: December 2012

Study information

• Verified date: January 2007
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• dietary intervention

Locations

Country	Name	City	State
Australia	Baker Heart Research Insitute	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia,