Comparison of Postprandial Inflammation in Lean and Obese Subjects

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446068
• Other study ID #: NUTRICHIP-1
• Status: Completed
• Phase: Phase 0
• First received: September 29, 2011
• Last updated: June 19, 2013
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Agroscope Liebefeld-Posieux Research Station ALP
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Nutritional Intervention
• Obesity

Intervention

Dietary Supplement:
• High-fat meal
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)

Locations

Country	Name	City	State
Switzerland	Agroscope Liebefeld-Posieux ALP Research Station	Berne
Switzerland	University Hospital Inselspital, Berne	Berne

Sponsors (2)

Lead Sponsor	Collaborator
Agroscope Liebefeld-Posieux Research Station ALP	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6 (serum)	A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h	4h vs 0h	No
Secondary	Glucose (serum)		0h, 1h, 2h, 4h, 6h	No
Secondary	Triglyceride (serum)		0h, 1h, 2h, 4h, 6h	No
Secondary	Insulin (serum)		0h, 1h, 2h, 4h, 6h	No
Secondary	high sensitivity C-Reactive Protein		0h, 1h, 2h, 4h, 6h	No
Secondary	HDL-cholesterol		0h, 1h, 2h, 4h, 6h	No
Secondary	Total cholesterol		0h, 1h, 2h, 4h, 6h	No
Secondary	Total cholesterol / HDL cholesterol		0h, 1h, 2h, 4h, 6h	No
Secondary	Interleukin-6 (serum)		0h, 1h, 2h, 4h, 6h	No
Secondary	Glucagon-like-protein-1 (serum)		0h, 1h 2h, 4h, 6h	No
Secondary	Endotoxin (serum)		0h, 1h, 2h, 4h, 6h	No