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Phospholipid Absorption of a Milk Phospholipid

This study has been completed.
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01327430
First received: March 30, 2011
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

The aim of the study is to investigate parameters of the lipid metabolism in plasma and feces of healthy subjects after a dietary supplementation of different dosages of milk phospholipids.


Condition Intervention
Healthy
 Dietary Supplement: Milk phospholipid

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of a Milk Phospholipid Supplementation on the Lipid Metabolism in Healthy Volunteers

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Change in plasma phospholipid concentration [ Time Frame: after 0, 10, 20, and 30 days ] [ Designated as safety issue: Yes ]

    Total phospholipid concentration

    Individual phospholipid concentration (lyso phosphatidylcholine, phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylinositol)



Secondary Outcome Measures:
  • Plasma lipids [ Time Frame: after 0,10,20, and 30 days ] [ Designated as safety issue: Yes ]

    Fatty acid fraction (total fatty acid distribution, phospholipid fatty acid distribution)

    Cholesterol fraction (total cholesterol, LDL cholesterol, HDL cholesterol)

    Triacylglycerides fraction


  • Fecal lipids [ Time Frame: after 0,10,20, and 30 days ] [ Designated as safety issue: No ]
    Fecal lipids (crude fat, total phospholipids, sterols, bile acids)


Enrollment: 15
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phospholipid supplementation
Supplementation of milk phospholipid
 Dietary Supplement: 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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • age: between 30 and 45 years

Exclusion Criteria:

  • metabolic diseases
  • arteriosclerosis
  • pregnancy and breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327430

Locations
Germany
Friedrich Schiller University of Jena, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University, Department of Nutritional Physiology
  More Information

No publications provided

Responsible Party: Prof. Dr. G. Jahreis, Friedrich Schiller University of Jena, Department of Nutritional Physiology
ClinicalTrials.gov Identifier: NCT01327430     History of Changes
Other Study ID Numbers: LSEP H44-10
Study First Received: March 30, 2011
Last Updated: March 31, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
glycerophosphates
sphingomyelins

ClinicalTrials.gov processed this record on May 21, 2013