Clinical trial NCT01446068: Comparison of Postprandial Inflammation in Lean and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Nutritional Intervention
Nutritional and Metabolic Diseases
Obesity
Lead sponsor: Agroscope Liebefeld-Posieux Research Station ALP
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2011-10-04
Enrollment: 36
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Interleukin-6 (serum)
timeFrame: 4h vs 0h
Secondary outcomes:
measure: Glucose (serum)
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: Triglyceride (serum)
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: Insulin (serum)
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: high sensitivity C-Reactive Protein
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: HDL-cholesterol
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: Total cholesterol
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: Total cholesterol / HDL cholesterol
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: Interleukin-6 (serum)
timeFrame: 0h, 1h, 2h, 4h, 6h
measure: Glucagon-like-protein-1 (serum)
timeFrame: 0h, 1h 2h, 4h, 6h
measure: Endotoxin (serum)
timeFrame: 0h, 1h, 2h, 4h, 6h
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Agroscope Liebefeld-Posieux ALP Research Station
city: Berne
country: Switzerland
facility: University Hospital Inselspital, Berne
Study officials:
affiliation: Inselspital University of Berne
name: Kurt Laederach, MD
role: STUDY_DIRECTOR
affiliation: Agroscope Liebefeld-Posieux ALP Research Station
name: Katrin Bolanz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Agroscope Liebefeld-Posieux ALP Research Station
name: Flurina Schwander, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inselspital University of Berne
name: Caroline Buri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.