Effects of Food Cooking on Diabetes-2 Risk Factors (Age-2)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Cardiovascular Disease; Insulin Resistance; Type 2 Diabetes
• Intervention / Treatment: Other: Dietary intervention

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark
    • Department of Human Nutrition, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women, healthy between 20 and 50 y
• BMI between 25 and 40 kg/m2
• weight circumference over 88 cm

Exclusion Criteria:

• weigh changes within the last 2 months more than +/- 3 kg
• Physical activity more than 8 h per week
• smoking
• medications and supplements
• being vegetarian or vegan
• pregnancy or breast feeding
• postmenopause
• chronic disease
• previous gastric bypass surgery
• blood donation within the last 3 months
• Involvement in other clinical trials
• allergic to paraaminobenzoic acid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in HOMA from baseline to 4 weeks	insulin sensitivity	0 and 4 weeks
change in OGTT from baseline to 4 weeks	insulin sensitivity	0 and 4 weeks at 0 and 120 min
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: The Ministry of Science, Technology and Innovation, Denmark
• Investigators: Principal Investigator: Susanne G Bügel, Department of Human Nutrition, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: insulin sensitivity; obesity; appetite; inflammation; metabolomics; CVD; advanced glycation end products
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Cardiovascular Diseases; Insulin Resistance
• Other Study ID Numbers: M201