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

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:
NCT01617304
First received: February 22, 2012
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • change in HOMA from baseline to 4 weeks [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
    insulin sensitivity

  • change in OGTT from baseline to 4 weeks [ Time Frame: 0 and 4 weeks at 0 and 120 min ] [ Designated as safety issue: No ]
    insulin sensitivity

  • change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
  • change in plasma and urin AGEs from baseline to 4 weeks [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • change in metabolomics dats from baseline to 4 weeks [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
  • change in AGE levels in skin from baseline to 4 weeks [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
  • change in HbA1c from baseline to 4 weeks [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AAstrup, Head of Department, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01617304     History of Changes
Other Study ID Numbers: M201
Study First Received: February 22, 2012
Last Updated: January 8, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on May 16, 2013