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Comparison of Postprandial Inflammation in Lean and Obese Subjects

This study is ongoing, but not recruiting participants.
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: May 16, 2012
Last verified: May 2012
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: June 2012
Estimated 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

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446068

Locations
Switzerland
University Hospital Inselspital, Berne
Berne, Switzerland, 3010
Agroscope Liebefeld-Posieux ALP Research Station
Berne, Switzerland, 3003
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

No publications provided

Responsible Party: Agroscope Liebefeld-Posieux Research Station ALP
ClinicalTrials.gov Identifier: NCT01446068     History of Changes
Other Study ID Numbers: NUTRICHIP-1
Study First Received: September 29, 2011
Last Updated: May 16, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Metabolic Diseases
Obesity
Food Habits
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Habits

ClinicalTrials.gov processed this record on May 19, 2013