Comparison of Postprandial Inflammation in Lean and Obese Subjects
1 other identifier
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Mar 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 20, 2013
June 1, 2013
1.3 years
September 29, 2011
June 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Interleukin-6 (serum)
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h
4h vs 0h
Secondary Outcomes (10)
Glucose (serum)
0h, 1h, 2h, 4h, 6h
Triglyceride (serum)
0h, 1h, 2h, 4h, 6h
Insulin (serum)
0h, 1h, 2h, 4h, 6h
high sensitivity C-Reactive Protein
0h, 1h, 2h, 4h, 6h
HDL-cholesterol
0h, 1h, 2h, 4h, 6h
- +5 more secondary outcomes
Study Arms (2)
Lean Subjects
EXPERIMENTALObese subjects
EXPERIMENTALInterventions
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)
Eligibility Criteria
You may qualify if:
- age 25-50
- \<BMI\<25
- waist circumference \<94cm
- age-matched to healthy subjects
- \<BMI\<40
- waist circumference \>102cm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Agroscope Liebefeld-Posieux ALP Research Station
Bern, Canton of Bern, 3003, Switzerland
University Hospital Inselspital, Berne
Bern, Canton of Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 24812072DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 4, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2012
Study Completion
January 1, 2013
Last Updated
June 20, 2013
Record last verified: 2013-06