- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01327430
Phospholipid Absorption of a Milk Phospholipid
Effect of a Milk Phospholipid Supplementation on the Lipid Metabolism in Healthy Volunteers
Study Overview
Detailed Description
To date the mechanisms for the intestinal absorption of glycerophosphates and sphingolipids are not completely investigated. It is assumed, that sphingolipids and sterols compete for intestinal absorption. In addition it is unclear, if a dietary phospholipid supplementation may influence the phospholipid concentration in plasma.
To evaluate the effect of a dietary phospholipid supplementation 15 healthy female subjects received over 10 days daily 3 g of milk phospholipids stirred in a dairy product. During the following 10 days the subjects were supplemented with daily 6 g milk phospholipid. Finally, the subjects received over 10 days 6 g of the milk phospholipid in a dairy product and 2 g of plant sterols serving a commercial product.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thuringia
-
Jena, Thuringia, Germany, 07743
- Friedrich Schiller University of Jena, Department of Nutritional Physiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female
- age: between 30 and 45 years
Exclusion Criteria:
- metabolic diseases
- arteriosclerosis
- pregnancy and breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phospholipid supplementation
Supplementation of milk phospholipid
|
During day 1 until 10 the subjects were supplemented with daily 3 g milk phospholipids, during the day 11 and 20 the supplementation was increased to daily 6 g, and during the day 21 and 30 the subjects received daily 6 g milk phospholipids and 2 g of plant sterols.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma phospholipid concentration
Time Frame: after 0, 10, 20, and 30 days
|
Total phospholipid concentration Individual phospholipid concentration (lyso phosphatidylcholine, phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylinositol) |
after 0, 10, 20, and 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma lipids
Time Frame: after 0,10,20, and 30 days
|
Fatty acid fraction (total fatty acid distribution, phospholipid fatty acid distribution) Cholesterol fraction (total cholesterol, LDL cholesterol, HDL cholesterol) Triacylglycerides fraction |
after 0,10,20, and 30 days
|
Fecal lipids
Time Frame: after 0,10,20, and 30 days
|
Fecal lipids (crude fat, total phospholipids, sterols, bile acids)
|
after 0,10,20, and 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerhard Jahreis, Prof. Dr., Friedrich Schiller University, Department of Nutritional Physiology
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LSEP H44-10
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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