Comparison of Postprandial Inflammation in Lean and Obese Subjects

Early Phase 1

Completed

• Conditions: Nutritional Intervention; Nutritional and Metabolic Diseases; Obesity

• Registration Number: NCT01446068
• Lead Sponsor: Agroscope Liebefeld-Posieux Research Station ALP

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-10-03
• Study First Posted: 2011-10-04
• Primary Completion: 2012-06
• Study Completion: 2013-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Total cholesterol	0h, 1h, 2h, 4h, 6h
Total cholesterol / HDL cholesterol	0h, 1h, 2h, 4h, 6h
Interleukin-6 (serum)	0h, 1h, 2h, 4h, 6h
Glucagon-like-protein-1 (serum)	0h, 1h 2h, 4h, 6h
Endotoxin (serum)	0h, 1h, 2h, 4h, 6h

Trial Locations

Locations (2)

Agroscope Liebefeld-Posieux ALP Research Station; 🇨🇭 Berne, Switzerland

University Hospital Inselspital, Berne; 🇨🇭 Berne, Switzerland