Effects of Advanced Glycation Endproducts on Satiety and Inflammation

Obesity Clinical Trial

— AGE-1  

Official title:

Crossover Meal Study Investigating Effects of Advanced Glycation Endproducts on Satiety and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434407
• Other study ID #: M200
• Status: Completed
• Phase: N/A
• First received: September 13, 2011
• Last updated: September 3, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthichsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the meal study is to investigate acute effects on satiety and inflammation of advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the meal is affected by food preparation methods: frying/grilling versus boiling/steaming.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy males and females between 20 and 50 years old

• BMI 25-40

• Waist circumference above 88 cm for women and above 102 cm for men

Exclusion Criteria:

• Exercise training above 8 hour/week

• Smoking

• Pregnant or breast-feeding women

• Post-menstrual women

• Regular use of medicine (except contraceptive pills)

• Previous gastric bypass surgery

• Donation of blood within the last 3 months

• Involvement in other clinical trials

• Allergic to paraaminobenzoic acid

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Other:
• Dietary meal intervention
Test meals with different AGE content made by different cooking methods

Locations

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

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	Appetite sensation	Appetite sensation measured by visual analogue scales	Every 30 min up to 5 hours after test meal	No
Primary	Plasma ghrelin		Continuous measurement up to 5 hours after test meal	No
Primary	Plasma GLP-1		Continuous measurements up to 5 hours after test meal	No
Primary	Plasma PYY		Continuous measurements up to 5 hours after test meal	No
Primary	Plasma insulin		Continuous measurements up to 5 hours after test meal	No
Primary	Plasma glucose		Continuous measurements up to 5 hours after test meal	No
Primary	Urine AGE		From 24 hour before to 48 hour after test meal	No
Secondary	Plasma triglycerides		Continuous measurements up to 5 hours after test meal	No
Secondary	Expression of genes related to AGE		Continuous measurements up to 24 hours after test meal	No
Secondary	IL-1 beta		Continuous measurements up to 5 hours after test meal	No
Secondary	IL-6		Continuous measurements up to 5 hours after test meal	No
Secondary	TNF-alpha		Continuous measurements up to 5 hours after test meal	No
Secondary	CRP		Continuous measurements up to 5 hours after test meal	No
Secondary	VCAM		Continuous measurements up to 5 hours after test meal	No
Secondary	ICAM		Continuous measurements up to 5 hours after test meal	No
Secondary	MIF		Continuous measurements up to 5 hours after test meal	No
Secondary	Plasma AGE		Continuous measurements up to 48 hours after test meal	No
Secondary	Urine isoprostanes		From 24 hour before to 24 hours after test meal	No