- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343576
Effect of Dairy Fat on Plasma Phytanic Acid in Human
April 26, 2011 updated by: University of Copenhagen
Effect of Dairy Fat on Plasma Phytanic Acid in Healthy Volunteers - A Randomized Controlled Study
The aim of the study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
-
Frederiksberg, Denmark, 1958
- Department of Human Nutrition
-
-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- sign written consent
- Age: 20-42
- BMI: 20-30
- increased risk of developing MS
- refrain from dietary supplements and blood donations prior to, and during the study
Exclusion Criteria:
- poor compliance
- if they suffering from any chronic or long lasting illness
- abuse of alcohol or medicine
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: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma phytanic acid
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total cholesterol
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
LDL cholesterol
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
HDL cholesterol
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
triacylglycerol
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
C-reactive protein
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
insulin
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
glucose
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
fatty acid composition in plasma
Time Frame: before and after the intervention (4 weeks)
|
before and after the intervention (4 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tine Tholstrup, lector, Department of Human Nutrition, University of Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 18, 2011
First Submitted That Met QC Criteria
April 26, 2011
First Posted (Estimate)
April 28, 2011
Study Record Updates
Last Update Posted (Estimate)
April 28, 2011
Last Update Submitted That Met QC Criteria
April 26, 2011
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-B-2009-052 (Adel)
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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