NCT01617304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

February 22, 2012

Last Update Submit

January 8, 2013

Conditions

ObesityType 2 DiabetesInsulin ResistanceCardiovascular Disease

Keywords

advanced glycation end productsinsulin sensitivityobesityinflammationmetabolomicsappetiteCVD

Outcome Measures

Primary Outcomes (7)

  • change in HOMA from baseline to 4 weeks

    insulin sensitivity

    0 and 4 weeks

  • change in OGTT from baseline to 4 weeks

    insulin sensitivity

    0 and 4 weeks at 0 and 120 min

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

    0 and 4 weeks

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

    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

    0 and 4 weeks

  • change in metabolomics dats from baseline to 4 weeks

    0 and 4 weeks

  • change in AGE levels in skin from baseline to 4 weeks

    0 and 4 weeks

Secondary Outcomes (2)

  • 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

Study Arms (4)

low AGE, glucose

EXPERIMENTAL

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

Other: Dietary intervention

low AGE, fructose

EXPERIMENTAL

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

Other: Dietary intervention

high AGE, fructose

EXPERIMENTAL

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

Other: Dietary intervention

high AGE, glucose

EXPERIMENTAL

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

Other: Dietary intervention

Interventions

Dietary interventionOTHER

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

high AGE, fructosehigh AGE, glucoselow AGE, fructoselow AGE, glucose

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, University of Copenhagen

Frederiksberg, Denmark

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin ResistanceCardiovascular DiseasesInflammation

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinismPathologic Processes

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Susanne G Bugel

    Department of Human Nutrition, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

February 22, 2012

First Posted

June 12, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

DK(1)