NCT01434407

Brief Summary

The purpose of the meal study is to investigate acute effects on satiety and inflammation of advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the meal is affected by food preparation methods: frying/grilling versus boiling/steaming.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 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

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

7 months

First QC Date

September 13, 2011

Last Update Submit

September 3, 2012

Conditions

ObesityType 2 DiabetesInsulin ResistanceCardiovascular Disease

Keywords

Advanced glycation endproductsSatietyObesityInflammationInsulin resistance

Outcome Measures

Primary Outcomes (7)

  • Appetite sensation

    Appetite sensation measured by visual analogue scales

    Every 30 min up to 5 hours after test meal

  • Plasma ghrelin

    Continuous measurement up to 5 hours after test meal

  • Plasma GLP-1

    Continuous measurements up to 5 hours after test meal

  • Plasma PYY

    Continuous measurements up to 5 hours after test meal

  • Plasma insulin

    Continuous measurements up to 5 hours after test meal

  • Plasma glucose

    Continuous measurements up to 5 hours after test meal

  • Urine AGE

    From 24 hour before to 48 hour after test meal

Secondary Outcomes (11)

  • Plasma triglycerides

    Continuous measurements up to 5 hours after test meal

  • Expression of genes related to AGE

    Continuous measurements up to 24 hours after test meal

  • IL-1 beta

    Continuous measurements up to 5 hours after test meal

  • IL-6

    Continuous measurements up to 5 hours after test meal

  • TNF-alpha

    Continuous measurements up to 5 hours after test meal

  • +6 more secondary outcomes

Study Arms (2)

Low AGE meal

EXPERIMENTAL

Test meal prepared by boiling/steaming the food

Other: Dietary meal intervention

High AGE meal

EXPERIMENTAL

Test meal prepared by frying/grilling the food

Other: Dietary meal intervention

Interventions

Dietary meal interventionOTHER

Test meals with different AGE content made by different cooking methods

High AGE mealLow AGE meal

Eligibility Criteria

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

You may qualify if:

  • Healthy males and females between 20 and 50 years old
  • BMI 25-40
  • Waist circumference above 88 cm for women and above 102 cm for men

You may not qualify if:

  • Exercise training above 8 hour/week
  • Smoking
  • Pregnant or breast-feeding women
  • Post-menstrual women
  • Regular use of medicine (except contraceptive pills)
  • Previous gastric bypass surgery
  • Donation of blood 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

Copenhagen, Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

  • Poulsen MW, Bak MJ, Andersen JM, Monosik R, Giraudi-Futin AC, Holst JJ, Nielsen J, Lauritzen L, Larsen LH, Bugel S, Dragsted LO. Effect of dietary advanced glycation end products on postprandial appetite, inflammation, and endothelial activation in healthy overweight individuals. Eur J Nutr. 2014;53(2):661-72. doi: 10.1007/s00394-013-0574-y. Epub 2013 Aug 9.

    PMID: 23929260DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin ResistanceCardiovascular DiseasesInflammation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susanne G Bügel

    Department of Human Nutrition, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Med Sci

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 14, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

DK(1)