Back to resultsEffects of Advanced Glycation Endproducts on Satiety and Inflammation (AGE-1)
Primary Purpose
Obesity, Type 2 Diabetes, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dietary meal intervention
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Advanced glycation endproducts, Satiety, Obesity, Inflammation, Insulin resistance
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
Sites / Locations
- Department of Human Nutrition, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low AGE meal
High AGE meal
Arm Description
Test meal prepared by boiling/steaming the food
Test meal prepared by frying/grilling the food
Outcomes
Primary Outcome Measures
Appetite sensation
Appetite sensation measured by visual analogue scales
Plasma ghrelin
Plasma GLP-1
Plasma PYY
Plasma insulin
Plasma glucose
Urine AGE
Secondary Outcome Measures
Plasma triglycerides
Expression of genes related to AGE
IL-1 beta
IL-6
TNF-alpha
CRP
VCAM
ICAM
MIF
Plasma AGE
Urine isoprostanes
Full Information
NCT ID
NCT01434407
First Posted
September 13, 2011
Last Updated
September 3, 2012
Sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01434407
Brief Title
Effects of Advanced Glycation Endproducts on Satiety and Inflammation
Acronym
AGE-1
Official Title
Crossover Meal Study Investigating Effects of Advanced Glycation Endproducts on Satiety and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes, Insulin Resistance, Cardiovascular Disease
Keywords
Advanced glycation endproducts, Satiety, Obesity, Inflammation, Insulin resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low AGE meal
Arm Type
Experimental
Arm Description
Test meal prepared by boiling/steaming the food
Arm Title
High AGE meal
Arm Type
Experimental
Arm Description
Test meal prepared by frying/grilling the food
Intervention Type
Other
Intervention Name(s)
Dietary meal intervention
Intervention Description
Test meals with different AGE content made by different cooking methods
Primary Outcome Measure Information:
Title
Appetite sensation
Description
Appetite sensation measured by visual analogue scales
Time Frame
Every 30 min up to 5 hours after test meal
Title
Plasma ghrelin
Time Frame
Continuous measurement up to 5 hours after test meal
Title
Plasma GLP-1
Time Frame
Continuous measurements up to 5 hours after test meal
Title
Plasma PYY
Time Frame
Continuous measurements up to 5 hours after test meal
Title
Plasma insulin
Time Frame
Continuous measurements up to 5 hours after test meal
Title
Plasma glucose
Time Frame
Continuous measurements up to 5 hours after test meal
Title
Urine AGE
Time Frame
From 24 hour before to 48 hour after test meal
Secondary Outcome Measure Information:
Title
Plasma triglycerides
Time Frame
Continuous measurements up to 5 hours after test meal
Title
Expression of genes related to AGE
Time Frame
Continuous measurements up to 24 hours after test meal
Title
IL-1 beta
Time Frame
Continuous measurements up to 5 hours after test meal
Title
IL-6
Time Frame
Continuous measurements up to 5 hours after test meal
Title
TNF-alpha
Time Frame
Continuous measurements up to 5 hours after test meal
Title
CRP
Time Frame
Continuous measurements up to 5 hours after test meal
Title
VCAM
Time Frame
Continuous measurements up to 5 hours after test meal
Title
ICAM
Time Frame
Continuous measurements up to 5 hours after test meal
Title
MIF
Time Frame
Continuous measurements up to 5 hours after test meal
Title
Plasma AGE
Time Frame
Continuous measurements up to 48 hours after test meal
Title
Urine isoprostanes
Time Frame
From 24 hour before to 24 hours after test meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne G Bügel
Organizational Affiliation
Department of Human Nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition, University of Copenhagen
City
Copenhagen
State/Province
Frederiksberg C
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23929260
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.
Results Reference
derived
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Effects of Advanced Glycation Endproducts on Satiety and Inflammation
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