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Completed

NCT Number: NCT01327430

Phospholipid Absorption of a Milk Phospholipid

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.

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Key information

Conditions

Healthy

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University of Jena, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • age: between 30 and 45 years

Exclusion criteria

  • metabolic diseases
  • arteriosclerosis
  • pregnancy and breast feeding

Treatment and study plan

Milk phospholipid

Dietary Supplement

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Fecal lipids

    Time frame: after 0,10,20, and 30 days

    Fecal lipids (crude fat, total phospholipids, sterols, bile acids)

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

Effect of a Milk Phospholipid Supplementation on the Lipid Metabolism in Healthy Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2011
Registry last updated
Apr 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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