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Comparison of Postprandial Inflammation in Lean and Obese Subjects

Primary Purpose

Nutritional Intervention, Nutritional and Metabolic Diseases, Obesity

Status
Completed
Phase
Early Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
High-fat meal
Sponsored by
Agroscope Liebefeld-Posieux Research Station ALP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nutritional Intervention

Eligibility Criteria

25 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lean Subjects

Obese subjects

Arm Description

Outcomes

Primary Outcome Measures

Interleukin-6 (serum)
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h

Secondary Outcome Measures

Glucose (serum)
Triglyceride (serum)
Insulin (serum)
high sensitivity C-Reactive Protein
HDL-cholesterol
Total cholesterol
Total cholesterol / HDL cholesterol
Interleukin-6 (serum)
Glucagon-like-protein-1 (serum)
Endotoxin (serum)

Full Information

First Posted
September 29, 2011
Last Updated
June 19, 2013
Sponsor
Agroscope Liebefeld-Posieux Research Station ALP
Collaborators
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01446068
Brief Title
Comparison of Postprandial Inflammation in Lean and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agroscope Liebefeld-Posieux Research Station ALP
Collaborators
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Intervention, Nutritional and Metabolic Diseases, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean Subjects
Arm Type
Experimental
Arm Title
Obese subjects
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
High-fat meal
Intervention Description
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)
Primary Outcome Measure Information:
Title
Interleukin-6 (serum)
Description
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h
Time Frame
4h vs 0h
Secondary Outcome Measure Information:
Title
Glucose (serum)
Time Frame
0h, 1h, 2h, 4h, 6h
Title
Triglyceride (serum)
Time Frame
0h, 1h, 2h, 4h, 6h
Title
Insulin (serum)
Time Frame
0h, 1h, 2h, 4h, 6h
Title
high sensitivity C-Reactive Protein
Time Frame
0h, 1h, 2h, 4h, 6h
Title
HDL-cholesterol
Time Frame
0h, 1h, 2h, 4h, 6h
Title
Total cholesterol
Time Frame
0h, 1h, 2h, 4h, 6h
Title
Total cholesterol / HDL cholesterol
Time Frame
0h, 1h, 2h, 4h, 6h
Title
Interleukin-6 (serum)
Time Frame
0h, 1h, 2h, 4h, 6h
Title
Glucagon-like-protein-1 (serum)
Time Frame
0h, 1h 2h, 4h, 6h
Title
Endotoxin (serum)
Time Frame
0h, 1h, 2h, 4h, 6h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Laederach, MD
Organizational Affiliation
Inselspital University of Berne
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Katrin Bolanz, PhD
Organizational Affiliation
Agroscope Liebefeld-Posieux ALP Research Station
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flurina Schwander, M.Sc.
Organizational Affiliation
Agroscope Liebefeld-Posieux ALP Research Station
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline Buri, MD
Organizational Affiliation
Inselspital University of Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agroscope Liebefeld-Posieux ALP Research Station
City
Berne
ZIP/Postal Code
3003
Country
Switzerland
Facility Name
University Hospital Inselspital, Berne
City
Berne
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24812072
Citation
Schwander F, Kopf-Bolanz KA, Buri C, Portmann R, Egger L, Chollet M, McTernan PG, Piya MK, Gijs MA, Vionnet N, Pralong F, Laederach K, Vergeres G. A dose-response strategy reveals differences between normal-weight and obese men in their metabolic and inflammatory responses to a high-fat meal. J Nutr. 2014 Oct;144(10):1517-23. doi: 10.3945/jn.114.193565. Epub 2014 May 8.
Results Reference
derived

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Comparison of Postprandial Inflammation in Lean and Obese Subjects

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