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Completed

NCT Number: NCT01617304

Effects of Food Cooking on Diabetes-2 Risk Factors

The aim of the project is to investigate the effects of advanced glycation end products (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii) AGEs formation in the body is lower at low dietary intake of certain sugar forms.

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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

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, University of Copenhagen

Frederiksberg, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • women, healthy between 20 and 50 y
  • BMI between 25 and 40 kg/m2
  • weight circumference over 88 cm

Exclusion criteria

  • weigh changes within the last 2 months more than +/- 3 kg
  • Physical activity more than 8 h per week
  • smoking
  • medications and supplements
  • being vegetarian or vegan
  • pregnancy or breast feeding
  • postmenopause
  • chronic disease
  • previous gastric bypass surgery
  • blood donation within the last 3 months
  • Involvement in other clinical trials
  • allergic to paraaminobenzoic acid

Treatment and study plan

Dietary Intervention

Other

Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution

Primary outcomes

  1. change in HOMA from baseline to 4 weeks

    Time frame: 0 and 4 weeks

    insulin sensitivity

  2. change in OGTT from baseline to 4 weeks

    Time frame: 0 and 4 weeks at 0 and 120 min

    insulin sensitivity

  3. change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks

    Time frame: 0 and 4 weeks

  4. change in plasma and urin AGEs from baseline to 4 weeks

    Time frame: 0 and 4 weeks

  5. change in immune response (CRP, C-peptide, IL-1B, IL-6, VCAM, ICAM, MIF, TNF-a, buffycoat) from baseline to 4 weeks

    Time frame: 0 and 4 weeks

  6. change in metabolomics dats from baseline to 4 weeks

    Time frame: 0 and 4 weeks

  7. change in AGE levels in skin from baseline to 4 weeks

    Time frame: 0 and 4 weeks

Secondary outcomes

  1. change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks

    Time frame: 0 and 4 weeks

  2. change in HbA1c from baseline to 4 weeks

    Time frame: 0 and 4 weeks

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Acronym: Age-2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 12, 2012
Registry last updated
Jan 10, 2013

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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