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Comparison of Postprandial Inflammation in Lean and Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446068
First Posted: October 4, 2011
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Agroscope Liebefeld-Posieux Research Station ALP
  Purpose
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.

Condition Intervention Phase
Nutritional Intervention Nutritional and Metabolic Diseases Obesity Dietary Supplement: High-fat meal Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by Agroscope Liebefeld-Posieux Research Station ALP:

Primary Outcome Measures:
  • Interleukin-6 (serum) [ Time Frame: 4h vs 0h ]
    A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h


Secondary Outcome Measures:
  • Glucose (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • Triglyceride (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • Insulin (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • high sensitivity C-Reactive Protein [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • HDL-cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • Total cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • Total cholesterol / HDL cholesterol [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • Interleukin-6 (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ]
  • Glucagon-like-protein-1 (serum) [ Time Frame: 0h, 1h 2h, 4h, 6h ]
  • Endotoxin (serum) [ Time Frame: 0h, 1h, 2h, 4h, 6h ]

Enrollment: 36
Study Start Date: March 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lean Subjects Dietary Supplement: High-fat meal
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)
Experimental: Obese subjects Dietary Supplement: High-fat meal
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446068


Locations
Switzerland
Agroscope Liebefeld-Posieux ALP Research Station
Berne, Switzerland, 3003
University Hospital Inselspital, Berne
Berne, Switzerland, 3010
Sponsors and Collaborators
Agroscope Liebefeld-Posieux Research Station ALP
University Hospital Inselspital, Berne
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agroscope Liebefeld-Posieux Research Station ALP
ClinicalTrials.gov Identifier: NCT01446068     History of Changes
Other Study ID Numbers: NUTRICHIP-1
First Submitted: September 29, 2011
First Posted: October 4, 2011
Last Update Posted: June 20, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Metabolic Diseases