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

This study has been completed.
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01434407
First received: September 13, 2011
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

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 Intervention
Obesity
Type 2 Diabetes
Insulin Resistance
Cardiovascular Disease
Other: Dietary meal intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Crossover Meal Study Investigating Effects of Advanced Glycation Endproducts on Satiety and Inflammation

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Appetite sensation [ Time Frame: Every 30 min up to 5 hours after test meal ] [ Designated as safety issue: No ]
    Appetite sensation measured by visual analogue scales

  • Plasma ghrelin [ Time Frame: Continuous measurement up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • Plasma GLP-1 [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • Plasma PYY [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • Plasma insulin [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • Plasma glucose [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • Urine AGE [ Time Frame: From 24 hour before to 48 hour after test meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma triglycerides [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • Expression of genes related to AGE [ Time Frame: Continuous measurements up to 24 hours after test meal ] [ Designated as safety issue: No ]
  • IL-1 beta [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • IL-6 [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • TNF-alpha [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • VCAM [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • ICAM [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • MIF [ Time Frame: Continuous measurements up to 5 hours after test meal ] [ Designated as safety issue: No ]
  • Plasma AGE [ Time Frame: Continuous measurements up to 48 hours after test meal ] [ Designated as safety issue: No ]
  • Urine isoprostanes [ Time Frame: From 24 hour before to 24 hours after test meal ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434407

Locations
Denmark
Department of Human Nutrition, University of Copenhagen
Copenhagen, Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Principal Investigator: Susanne G Bügel Department of Human Nutrition, University of Copenhagen
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AAstrup, Dr Med Sci, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01434407     History of Changes
Other Study ID Numbers: M200
Study First Received: September 13, 2011
Last Updated: September 3, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethichs
Denmark: Danish Dataprotection Agency

Keywords provided by University of Copenhagen:
Advanced glycation endproducts
Satiety
Obesity
Inflammation
Insulin resistance

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Inflammation
Insulin Resistance
Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014