Impact of Dairy Products on Postprandial Inflammation

November 18, 2013 updated by: Guy Vergeres, Agroscope Liebefeld-Posieux Research Station ALP

The Impact of Dairy Products on Postprandial Inflammation in Obese Males

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital, Inselspital Berne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: high fat meal without dairy products
Other: consumption of high fat test meal without dairy products
Experimental: high fat meal with additional milk
Other: consumption of high fat test meal with dairy products
Experimental: dairy product meal
Other: consumption of test meal based on dairy products

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inflammation markers in blood plasma (IL-6, TNF-alpha)
Time Frame: 0,6h
0,6h

Secondary Outcome Measures

Outcome Measure
Time Frame
Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)
Time Frame: 0,1,2,4,6h
0,1,2,4,6h
Endotoxin in blood serum
Time Frame: 0,6h
0,6h

Other Outcome Measures

Outcome Measure
Time Frame
Blood cell transcriptome
Time Frame: 0,2,4,6h
0,2,4,6h
blood serum metabolome
Time Frame: 0,2,4,6h
0,2,4,6h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agroscope Liebefeld-Posieux Research Station ALP

Collaborators

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Kur Laederach, MD, University Hospital Inselspital, Berne
  • Study Director: Alexandra Schmid, Agroscope Liebefeld-Posieux ALP
  • Study Director: Caroline Buri, MD, PhD, University Hospital Inselspital, Berne
  • Study Director: Guy Vergères, PhD, Agroscope Liebefeld-Posieux ALP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTRICHIP-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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