HealthyNCT01327430
Phospholipid Absorption of a Milk Phospholipid
A study testing Milk phospholipid in people with Healthy, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Milk phospholipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- age: between 30 and 45 years
Who cannot join
- metabolic diseases
- arteriosclerosis
- pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich Schiller University of Jena, Department of Nutritional Physiology
Jena, Thuringia, 07743
About this study
Official title: Effect of a Milk Phospholipid Supplementation on the Lipid Metabolism in Healthy Volunteers
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Milk phospholipid
- Keywords
- glycerophosphates, sphingomyelins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Phospholipid supplementation | Experimental | Supplementation of milk phospholipid Receives: Dietary Supplement: Milk phospholipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma phospholipid concentration
Total phospholipid concentration
Individual phospholipid concentration (lyso phosphatidylcholine, phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylinositol)
Measured: after 0, 10, 20, and 30 days
Secondary outcomes (2)
Plasma lipids
Fatty acid fraction (total fatty acid distribution, phospholipid fatty acid distribution)
Cholesterol fraction (total cholesterol, LDL cholesterol, HDL cholesterol)
Triacylglycerides fraction
Measured: after 0,10,20, and 30 days
Fecal lipids
Fecal lipids (crude fat, total phospholipids, sterols, bile acids)
Measured: after 0,10,20, and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Friedrich Schiller University, Department of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327430
- Sponsor's protocol ID
- LSEP H44-10
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2011
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22836514
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Milk Phospholipid Supplementation on the Lipid Metabolism in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01327430
- Acronym / sponsor ID
- LSEP H44-10
- Conditions
- Healthy
- Keywords
- glycerophosphates, sphingomyelins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phospholipid supplementation | Experimental | Dietary Supplement: Milk phospholipidSupplementation of milk phospholipid |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female
- age: between 30 and 45 years
Key exclusion criteria (3 listed)
- metabolic diseases
- arteriosclerosis
- pregnancy and breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk phospholipidDuring 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. | Dietary supplement | Phospholipid supplementation |
Primary outcome
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)
2 secondary outcomes
Plasma lipids
Time frame: after 0,10,20, and 30 days
Fecal lipids
Time frame: after 0,10,20, and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
- Derived from this study: PubMed 22836514Keller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Jahreis, Prof. Dr. principal investigator
Friedrich Schiller University, Department of Nutritional Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk phospholipid in people with Healthy, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma phospholipid concentration (time frame: after 0, 10, 20, and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2011.