Effects of Food Cooking on Diabetes-2 Risk Factors

Obesity Clinical Trial

— Age-2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617304
• Other study ID #: M201
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: January 8, 2013
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Insulin Resistance
• Obesity
• Type 2 Diabetes

Intervention

Other:
• Dietary intervention
Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, University of Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HOMA from baseline to 4 weeks	insulin sensitivity	0 and 4 weeks	No
Primary	change in OGTT from baseline to 4 weeks	insulin sensitivity	0 and 4 weeks at 0 and 120 min	No
Primary	change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks		0 and 4 weeks	No
Primary	change in plasma and urin AGEs from baseline to 4 weeks		0 and 4 weeks	No
Primary	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	No
Primary	change in metabolomics dats from baseline to 4 weeks		0 and 4 weeks	No
Primary	change in AGE levels in skin from baseline to 4 weeks		0 and 4 weeks	No
Secondary	change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks		0 and 4 weeks	No
Secondary	change in HbA1c from baseline to 4 weeks		0 and 4 weeks	No