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Clinical Trials/NCT01617304
NCT01617304CompletedNot Applicable

Effects of Food Cooking on Diabetes-2 Risk Factors

University of Copenhagen1 site in 1 country100 target enrollmentStarted: December 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
change in HOMA from baseline to 4 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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
  • 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

Outcomes

Primary Outcomes

change in HOMA from baseline to 4 weeks

Time Frame: 0 and 4 weeks

insulin sensitivity

change in OGTT from baseline to 4 weeks

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

insulin sensitivity

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

Time Frame: 0 and 4 weeks

change in plasma and urin AGEs from baseline to 4 weeks

Time Frame: 0 and 4 weeks

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

change in metabolomics dats from baseline to 4 weeks

Time Frame: 0 and 4 weeks

change in AGE levels in skin from baseline to 4 weeks

Time Frame: 0 and 4 weeks

Secondary Outcomes

  • change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks(0 and 4 weeks)
  • change in HbA1c from baseline to 4 weeks(0 and 4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AAstrup

Head of Department

University of Copenhagen

Study Sites (1)

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