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Effects of Food Cooking on Diabetes-2 Risk Factors (Age-2)

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ClinicalTrials.gov Identifier: NCT01617304
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Insulin Resistance Cardiovascular Disease Other: Dietary intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : December 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: low AGE, glucose
Food prepared by boiling/steaming and 20 g of glucose 3 times a day in a water solution
Other: Dietary intervention
Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Experimental: low AGE, fructose
Food prepared by boiling/steaming and 20 g of fructose 3 times a day in a water solution
Other: Dietary intervention
Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Experimental: high AGE, fructose
Food prepared by frying/baking and 20 g of fructose 3 times a day in a water solution
Other: Dietary intervention
Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Experimental: high AGE, glucose
Food prepared by frying/baking and 20 g of glucose 3 times a day in a water solution
Other: Dietary intervention
Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617304


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

Responsible Party: AAstrup, Head of Department, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01617304     History of Changes
Other Study ID Numbers: M201
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by AAstrup, University of Copenhagen:
advanced glycation end products
insulin sensitivity
obesity
inflammation
metabolomics
appetite
CVD

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases