Age-2: Effects of Food Cooking on Diabetes-2 Risk Factors

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT01617304

Collaborator

The Ministry of Science, Technology and Innovation, Denmark (Other)

100

Enrollment

Location

Arms

Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the project is to investigate the effects of advanced glycation end products (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii) AGEs formation in the body is lower at low dietary intake of certain sugar forms.

Condition or Disease	Intervention/Treatment	Phase
Obesity Type 2 Diabetes Insulin Resistance Cardiovascular Disease	Other: Dietary intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low AGE, glucose Food prepared by boiling/steaming and 20 g of glucose 3 times a day in a water solution	Other: Dietary intervention Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Experimental: low AGE, fructose Food prepared by boiling/steaming and 20 g of fructose 3 times a day in a water solution	Other: Dietary intervention Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Experimental: high AGE, fructose Food prepared by frying/baking and 20 g of fructose 3 times a day in a water solution	Other: Dietary intervention Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Experimental: high AGE, glucose Food prepared by frying/baking and 20 g of glucose 3 times a day in a water solution	Other: Dietary intervention Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution

Outcome Measures

Primary Outcome Measures

change in HOMA from baseline to 4 weeks [0 and 4 weeks]
insulin sensitivity
change in OGTT from baseline to 4 weeks [0 and 4 weeks at 0 and 120 min]
insulin sensitivity
change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks [0 and 4 weeks]
change in plasma and urin AGEs from baseline to 4 weeks [0 and 4 weeks]
change in immune response (CRP, C-peptide, IL-1B, IL-6, VCAM, ICAM, MIF, TNF-a, buffycoat) from baseline to 4 weeks [0 and 4 weeks]
change in metabolomics dats from baseline to 4 weeks [0 and 4 weeks]
change in AGE levels in skin from baseline to 4 weeks [0 and 4 weeks]

Secondary Outcome Measures

change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks [0 and 4 weeks]
change in HbA1c from baseline to 4 weeks [0 and 4 weeks]