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

Primary Purpose

Obesity, Type 2 Diabetes, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring advanced glycation end products, insulin sensitivity, obesity, inflammation, metabolomics, appetite, CVD

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Human Nutrition, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

low AGE, glucose

low AGE, fructose

high AGE, fructose

high AGE, glucose

Arm Description

Food prepared by boiling/steaming and 20 g of glucose 3 times a day in a water solution

Food prepared by boiling/steaming and 20 g of fructose 3 times a day in a water solution

Food prepared by frying/baking and 20 g of fructose 3 times a day in a water solution

Food prepared by frying/baking and 20 g of glucose 3 times a day in a water solution

Outcomes

Primary Outcome Measures

change in HOMA from baseline to 4 weeks
insulin sensitivity
change in OGTT from baseline to 4 weeks
insulin sensitivity
change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks
change in plasma and urin AGEs from baseline to 4 weeks
change in immune response (CRP, C-peptide, IL-1B, IL-6, VCAM, ICAM, MIF, TNF-a, buffycoat) from baseline to 4 weeks
change in metabolomics dats from baseline to 4 weeks
change in AGE levels in skin from baseline to 4 weeks

Secondary Outcome Measures

change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks
change in HbA1c from baseline to 4 weeks

Full Information

First Posted
February 22, 2012
Last Updated
January 8, 2013
Sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01617304
Brief Title
Effects of Food Cooking on Diabetes-2 Risk Factors
Acronym
Age-2
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes, Insulin Resistance, Cardiovascular Disease
Keywords
advanced glycation end products, insulin sensitivity, obesity, inflammation, metabolomics, appetite, CVD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low AGE, glucose
Arm Type
Experimental
Arm Description
Food prepared by boiling/steaming and 20 g of glucose 3 times a day in a water solution
Arm Title
low AGE, fructose
Arm Type
Experimental
Arm Description
Food prepared by boiling/steaming and 20 g of fructose 3 times a day in a water solution
Arm Title
high AGE, fructose
Arm Type
Experimental
Arm Description
Food prepared by frying/baking and 20 g of fructose 3 times a day in a water solution
Arm Title
high AGE, glucose
Arm Type
Experimental
Arm Description
Food prepared by frying/baking and 20 g of glucose 3 times a day in a water solution
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Primary Outcome Measure Information:
Title
change in HOMA from baseline to 4 weeks
Description
insulin sensitivity
Time Frame
0 and 4 weeks
Title
change in OGTT from baseline to 4 weeks
Description
insulin sensitivity
Time Frame
0 and 4 weeks at 0 and 120 min
Title
change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks
Time Frame
0 and 4 weeks
Title
change in plasma and urin AGEs from baseline to 4 weeks
Time Frame
0 and 4 weeks
Title
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
Title
change in metabolomics dats from baseline to 4 weeks
Time Frame
0 and 4 weeks
Title
change in AGE levels in skin from baseline to 4 weeks
Time Frame
0 and 4 weeks
Secondary Outcome Measure Information:
Title
change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks
Time Frame
0 and 4 weeks
Title
change in HbA1c from baseline to 4 weeks
Time Frame
0 and 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne G Bugel
Organizational Affiliation
Department of Human Nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition, University of Copenhagen
City
Frederiksberg
Country
Denmark

12. IPD Sharing Statement

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Effects of Food Cooking on Diabetes-2 Risk Factors

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