Comparison of Postprandial Inflammation in Lean and Obese Subjects

This study has been completed.
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Agroscope Liebefeld-Posieux Research Station ALP
ClinicalTrials.gov Identifier:
NCT01446068
First received: September 29, 2011
Last updated: June 19, 2013
Last verified: June 2013

September 29, 2011
June 19, 2013
March 2011
June 2012   (final data collection date for primary outcome measure)
Interleukin-6 (serum) [ Time Frame: 4h vs 0h ] [ Designated as safety issue: No ]
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h
IL-6 (serum) [ Time Frame: 4h vs 0h ] [ Designated as safety issue: No ]
A statistically-significant increase in serum IL-6 is expected at 4h compared to 0h
Complete list of historical versions of study NCT01446068 on ClinicalTrials.gov Archive Site
  • Glucose (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Triglyceride (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Insulin (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • high sensitivity C-Reactive Protein [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Total cholesterol / HDL cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Interleukin-6 (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Glucagon-like-protein-1 (serum) [ Time Frame: 0h, 1h 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Endotoxin (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • TNF-alpha (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • IL-8 (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • IL-1beta (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • IL-10 (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Glucose (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Triglyceride (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Insulin (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • hsCRP [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • Total cholesterol / HDL cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ] [ Designated as safety issue: No ]
  • IL-6 (serum) [ Time Frame: 0h, 2h, 6h ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Postprandial Inflammation in Lean and Obese Subjects
Not Provided

The purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Nutritional Intervention
  • Nutritional and Metabolic Diseases
  • Obesity
Dietary Supplement: High-fat meal
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)
  • Experimental: Lean Subjects
    Intervention: Dietary Supplement: High-fat meal
  • Experimental: Obese subjects
    Intervention: Dietary Supplement: High-fat meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria for lean subjects:

  • age 25-50
  • 20<BMI<25
  • waist circumference <94cm

Inclusion Criteria for obese subjects

  • age-matched to healthy subjects
  • 30<BMI<40
  • waist circumference >102cm

Exclusion Criteria for lean and obese subjects:

  • Physiological or psychological diseases
  • Allergies to food or intolerance to high-fat meal
  • Vegetarians
  • Chronic intake of drugs
  • Smokers
  • Diabetes mellitus Type I and II
  • Debilitating kidney diseases
  • Debilitating liver diseases
  • Clinically established coronary heart diseases
  • Ingestion of vitamins or dietary supplements during the course of the study
Male
25 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01446068
NUTRICHIP-1
Yes
Agroscope Liebefeld-Posieux Research Station ALP
Agroscope Liebefeld-Posieux Research Station ALP
University Hospital Inselspital, Berne
Study Director: Kurt Laederach, MD Inselspital University of Berne
Principal Investigator: Katrin Bolanz, PhD Agroscope Liebefeld-Posieux ALP Research Station
Principal Investigator: Flurina Schwander, M.Sc. Agroscope Liebefeld-Posieux ALP Research Station
Principal Investigator: Caroline Buri, MD Inselspital University of Berne
Agroscope Liebefeld-Posieux Research Station ALP
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP