Back to resultsImpact of Dairy Products on Postprandial Inflammation
Primary Purpose
Inflammation, Obesity, Nutritional Intervention
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation
Eligibility Criteria
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
Sites / Locations
- University Hospital, Inselspital Berne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
high fat meal without dairy products
high fat meal with additional milk
dairy product meal
Arm Description
high fat meal without dairy products
high fat meal with additional milk
dairy product meal
Outcomes
Primary Outcome Measures
Inflammation markers in blood plasma (IL-6, TNF-alpha)
Secondary Outcome Measures
Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)
Endotoxin in blood serum
Full Information
NCT ID
NCT01885416
First Posted
June 19, 2013
Last Updated
November 18, 2013
Sponsor
Agroscope Liebefeld-Posieux Research Station ALP
Collaborators
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT01885416
Brief Title
Impact of Dairy Products on Postprandial Inflammation
Official Title
The Impact of Dairy Products on Postprandial Inflammation in Obese Males
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agroscope Liebefeld-Posieux Research Station ALP
Collaborators
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Obesity, Nutritional Intervention
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high fat meal without dairy products
Arm Type
Active Comparator
Arm Description
high fat meal without dairy products
Arm Title
high fat meal with additional milk
Arm Type
Experimental
Arm Description
high fat meal with additional milk
Arm Title
dairy product meal
Arm Type
Experimental
Arm Description
dairy product meal
Intervention Type
Other
Intervention Name(s)
consumption of test meal based on dairy products
Intervention Type
Other
Intervention Name(s)
consumption of high fat test meal without dairy products
Intervention Type
Other
Intervention Name(s)
consumption of high fat test meal with dairy products
Primary Outcome Measure Information:
Title
Inflammation markers in blood plasma (IL-6, TNF-alpha)
Time Frame
0,6h
Secondary Outcome Measure Information:
Title
Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)
Time Frame
0,1,2,4,6h
Title
Endotoxin in blood serum
Time Frame
0,6h
Other Pre-specified Outcome Measures:
Title
Blood cell transcriptome
Time Frame
0,2,4,6h
Title
blood serum metabolome
Time Frame
0,2,4,6h
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kur Laederach, MD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandra Schmid
Organizational Affiliation
Agroscope Liebefeld-Posieux ALP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caroline Buri, MD, PhD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guy Vergères, PhD
Organizational Affiliation
Agroscope Liebefeld-Posieux ALP
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital, Inselspital Berne
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Impact of Dairy Products on Postprandial Inflammation
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