Comparison of Postprandial Inflammation in Lean and Obese Subjects

June 19, 2013 updated by: Agroscope Liebefeld-Posieux Research Station ALP
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-6 (serum)
Time Frame: 4h vs 0h
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h
4h vs 0h

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agroscope Liebefeld-Posieux Research Station ALP

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

October 3, 2011

First Posted (Estimate)

October 4, 2011

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTRICHIP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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