Impact of Dairy Products on Postprandial Inflammation
The Impact of Dairy Products on Postprandial Inflammation in Obese Males
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 19, 2013
November 1, 2013
8 months
June 19, 2013
November 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Inflammation markers in blood plasma (IL-6, TNF-alpha)
0,6h
Secondary Outcomes (2)
Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)
0,1,2,4,6h
Endotoxin in blood serum
0,6h
Other Outcomes (2)
Blood cell transcriptome
0,2,4,6h
blood serum metabolome
0,2,4,6h
Study Arms (3)
high fat meal without dairy products
ACTIVE COMPARATORhigh fat meal without dairy products
high fat meal with additional milk
EXPERIMENTALhigh fat meal with additional milk
dairy product meal
EXPERIMENTALdairy product meal
Interventions
Eligibility Criteria
You may qualify if:
- male
- BMI ≥ 20 kg/m2
- age 25-55 y
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Inselspital Berne
Bern, Canton of Bern, 3010, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kur Laederach, MD
Insel Gruppe AG, University Hospital Bern
- STUDY DIRECTOR
Alexandra Schmid
Agroscope Liebefeld-Posieux ALP
- STUDY DIRECTOR
Caroline Buri, MD, PhD
Insel Gruppe AG, University Hospital Bern
- STUDY DIRECTOR
Guy Vergères, PhD
Agroscope Liebefeld-Posieux ALP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 19, 2013
First Posted
June 25, 2013
Study Start
January 1, 2013
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
November 19, 2013
Record last verified: 2013-11