Impact of Dairy Products on Postprandial Inflammation

Obesity Clinical Trial

Official title:

The Impact of Dairy Products on Postprandial Inflammation in Obese Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885416
• Other study ID #: NUTRICHIP-2
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: November 18, 2013
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: November 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 study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• male

• BMI = 20 kg/m2

• age 25-55 y

• informed consent

Exclusion Criteria:

• 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, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation
• Nutritional Intervention
• Obesity

Intervention

Other:
• consumption of test meal based on dairy products

• consumption of high fat test meal without dairy products

• consumption of high fat test meal with dairy products

Locations

Country	Name	City	State
Switzerland	University Hospital, Inselspital Berne	Bern

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
Other	Blood cell transcriptome		0,2,4,6h	No
Other	blood serum metabolome		0,2,4,6h	No
Primary	Inflammation markers in blood plasma (IL-6, TNF-alpha)		0,6h	No
Secondary	Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)		0,1,2,4,6h	No
Secondary	Endotoxin in blood serum		0,6h	No