AGE-1: Effects of Advanced Glycation Endproducts on Satiety and Inflammation

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT01434407

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low AGE meal Test meal prepared by boiling/steaming the food	Other: Dietary meal intervention Test meals with different AGE content made by different cooking methods
Experimental: High AGE meal Test meal prepared by frying/grilling the food	Other: Dietary meal intervention Test meals with different AGE content made by different cooking methods

Arm

Intervention/Treatment

Experimental: Low AGE meal

Test meal prepared by boiling/steaming the food

Other: Dietary meal intervention

Test meals with different AGE content made by different cooking methods

Experimental: High AGE meal

Test meal prepared by frying/grilling the food

Other: Dietary meal intervention

Test meals with different AGE content made by different cooking methods

Outcome Measures

Primary Outcome Measures

Appetite sensation [Every 30 min up to 5 hours after test meal]
Appetite sensation measured by visual analogue scales
Plasma ghrelin [Continuous measurement up to 5 hours after test meal]
Plasma GLP-1 [Continuous measurements up to 5 hours after test meal]
Plasma PYY [Continuous measurements up to 5 hours after test meal]
Plasma insulin [Continuous measurements up to 5 hours after test meal]
Plasma glucose [Continuous measurements up to 5 hours after test meal]
Urine AGE [From 24 hour before to 48 hour after test meal]

Secondary Outcome Measures

Plasma triglycerides [Continuous measurements up to 5 hours after test meal]
Expression of genes related to AGE [Continuous measurements up to 24 hours after test meal]
IL-1 beta [Continuous measurements up to 5 hours after test meal]
IL-6 [Continuous measurements up to 5 hours after test meal]
TNF-alpha [Continuous measurements up to 5 hours after test meal]
CRP [Continuous measurements up to 5 hours after test meal]
VCAM [Continuous measurements up to 5 hours after test meal]
ICAM [Continuous measurements up to 5 hours after test meal]
MIF [Continuous measurements up to 5 hours after test meal]
Plasma AGE [Continuous measurements up to 48 hours after test meal]
Urine isoprostanes [From 24 hour before to 24 hours after test meal]