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

September 3, 2012 updated by: AAstrup, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg C
      • Copenhagen, Frederiksberg C, Denmark, 1958
        • Department of Human Nutrition, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

The Ministry of Science, Technology and Innovation, Denmark

Investigators

  • Principal Investigator: Susanne G Bügel, Department of Human Nutrition, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe