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Completed

NCT Number: NCT01434407

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, University of Copenhagen

Copenhagen, Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary meal intervention

Other

Test meals with different AGE content made by different cooking methods

Primary outcomes

  1. Appetite sensation

    Time frame: Every 30 min up to 5 hours after test meal

    Appetite sensation measured by visual analogue scales

  2. Plasma ghrelin

    Time frame: Continuous measurement up to 5 hours after test meal

  3. Plasma GLP-1

    Time frame: Continuous measurements up to 5 hours after test meal

  4. Plasma PYY

    Time frame: Continuous measurements up to 5 hours after test meal

  5. Plasma insulin

    Time frame: Continuous measurements up to 5 hours after test meal

  6. Plasma glucose

    Time frame: Continuous measurements up to 5 hours after test meal

  7. Urine AGE

    Time frame: From 24 hour before to 48 hour after test meal

Secondary outcomes

  1. Plasma triglycerides

    Time frame: Continuous measurements up to 5 hours after test meal

  2. Expression of genes related to AGE

    Time frame: Continuous measurements up to 24 hours after test meal

  3. IL-1 beta

    Time frame: Continuous measurements up to 5 hours after test meal

  4. IL-6

    Time frame: Continuous measurements up to 5 hours after test meal

  5. TNF-alpha

    Time frame: Continuous measurements up to 5 hours after test meal

  6. CRP

    Time frame: Continuous measurements up to 5 hours after test meal

  7. VCAM

    Time frame: Continuous measurements up to 5 hours after test meal

  8. ICAM

    Time frame: Continuous measurements up to 5 hours after test meal

  9. MIF

    Time frame: Continuous measurements up to 5 hours after test meal

  10. Plasma AGE

    Time frame: Continuous measurements up to 48 hours after test meal

  11. Urine isoprostanes

    Time frame: From 24 hour before to 24 hours after test meal

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study title

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

Acronym: AGE-1

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 14, 2011
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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