Clinical trial NCT01434407: Effects of Advanced Glycation Endproducts on Satiety and Inflammation
Official title: Crossover Meal Study Investigating Effects of Advanced Glycation Endproducts on Satiety and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Insulin Resistance
Cardiovascular Disease
Keywords: Advanced glycation endproducts
Satiety
Obesity
Inflammation
Insulin resistance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2011-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Appetite sensation
timeFrame: Every 30 min up to 5 hours after test meal
measure: Plasma ghrelin
timeFrame: Continuous measurement up to 5 hours after test meal
measure: Plasma GLP-1
timeFrame: Continuous measurements up to 5 hours after test meal
measure: Plasma PYY
timeFrame: Continuous measurements up to 5 hours after test meal
measure: Plasma insulin
timeFrame: Continuous measurements up to 5 hours after test meal
measure: Plasma glucose
timeFrame: Continuous measurements up to 5 hours after test meal
measure: Urine AGE
timeFrame: From 24 hour before to 48 hour after test meal
Secondary outcomes:
measure: Plasma triglycerides
timeFrame: Continuous measurements up to 5 hours after test meal
measure: Expression of genes related to AGE
timeFrame: Continuous measurements up to 24 hours after test meal
measure: IL-1 beta
timeFrame: Continuous measurements up to 5 hours after test meal
measure: IL-6
timeFrame: Continuous measurements up to 5 hours after test meal
measure: TNF-alpha
timeFrame: Continuous measurements up to 5 hours after test meal
measure: CRP
timeFrame: Continuous measurements up to 5 hours after test meal
measure: VCAM
timeFrame: Continuous measurements up to 5 hours after test meal
measure: ICAM
timeFrame: Continuous measurements up to 5 hours after test meal
measure: MIF
timeFrame: Continuous measurements up to 5 hours after test meal
measure: Plasma AGE
timeFrame: Continuous measurements up to 48 hours after test meal
measure: Urine isoprostanes
timeFrame: From 24 hour before to 24 hours after test meal
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Human Nutrition, University of Copenhagen
state: Frederiksberg C
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Susanne G Bügel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poulsen MW, Bak MJ, Andersen JM, Monosik R, Giraudi-Futin AC, Holst JJ, Nielsen J, Lauritzen L, Larsen LH, Bugel S, Dragsted LO. Effect of dietary advanced glycation end products on postprandial appetite, inflammation, and endothelial activation in healthy overweight individuals. Eur J Nutr. 2014;53(2):661-72. doi: 10.1007/s00394-013-0574-y. Epub 2013 Aug 9.