NCT01327430

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
Last Updated

April 1, 2011

Status Verified

March 1, 2011

Enrollment Period

1 month

First QC Date

March 30, 2011

Last Update Submit

March 31, 2011

Conditions

Healthy

Keywords

glycerophosphatessphingomyelins

Outcome Measures

Primary Outcomes (1)

  • Change in plasma phospholipid concentration

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

    after 0, 10, 20, and 30 days

Secondary Outcomes (2)

  • Plasma lipids

    after 0,10,20, and 30 days

  • Fecal lipids

    after 0,10,20, and 30 days

Study Arms (1)

Phospholipid supplementation

EXPERIMENTAL

Supplementation of milk phospholipid

Dietary Supplement: Milk phospholipid

Interventions

Milk phospholipidDIETARY_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.

Phospholipid supplementation

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • age: between 30 and 45 years

You may not qualify if:

  • metabolic diseases
  • arteriosclerosis
  • pregnancy and breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich Schiller University of Jena, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • Keller S, Malarski A, Reuther C, Kertscher R, Kiehntopf M, Jahreis G. Milk phospholipid and plant sterol-dependent modulation of plasma lipids in healthy volunteers. Eur J Nutr. 2013 Apr;52(3):1169-79. doi: 10.1007/s00394-012-0427-0. Epub 2012 Jul 27.

    PMID: 22836514DERIVED

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    Friedrich Schiller University, Department of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 1, 2011

Record last verified: 2011-03

Locations

DE(1)