Coronary Heart DiseaseNCT01343576
Effect of Dairy Fat on Plasma Phytanic Acid in Human
A study testing milk fat in people with Coronary Heart Disease, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- milk fat
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Dec 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sign written consent
- Age: 20-42
- BMI: 20-30
- increased risk of developing MS
- refrain from dietary supplements and blood donations prior to, and during the study
Who cannot join
- poor compliance
- if they suffering from any chronic or long lasting illness
- abuse of alcohol or medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dairy Fat on Plasma Phytanic Acid in Healthy Volunteers - A Randomized Controlled Study
The aim of the study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.
- Conditions
- Coronary Heart Disease
- Being tested
- milk fat
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk fatDietary supplement
Also called yellow group, Green group
45 g milk fat per day in 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma phytanic acid
Measured: before and after the intervention (4 weeks)
Secondary outcomes (8)
total cholesterol
Measured: before and after the intervention (4 weeks)
LDL cholesterol
Measured: before and after the intervention (4 weeks)
HDL cholesterol
Measured: before and after the intervention (4 weeks)
triacylglycerol
Measured: before and after the intervention (4 weeks)
C-reactive protein
Measured: before and after the intervention (4 weeks)
insulin
Measured: before and after the intervention (4 weeks)
glucose
Measured: before and after the intervention (4 weeks)
fatty acid composition in plasma
Measured: before and after the intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionDec 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 Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, The Danish Council for Strategic Research
- Investigators
- Tine Tholstrup, lector, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343576
- Sponsor's protocol ID
- H-B-2009-052 (Adel)
- Status last verified
- Nov 2009
- First submitted
- 18 Apr 2011
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Werner LB, Hellgren LI, Raff M, Jensen SK, Petersen RA, Drachmann T, Tholstrup T. Effect of dairy fat on plasma phytanic acid in healthy volunteers - a randomized controlled study. Lipids Health Dis. 2011 Jun 10;10:95. doi: 10.1186/1476-511X-10-95.
PubMed 21663648
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dairy Fat on Plasma Phytanic Acid in Healthy Volunteers - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01343576
- Acronym / sponsor ID
- H-B-2009-052 (Adel)
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, The Danish Council for Strategic Research
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 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 if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- sign written consent
- Age: 20-42
- BMI: 20-30
- increased risk of developing MS
- refrain from dietary supplements and blood donations prior to, and during the study
Key exclusion criteria (3 listed)
- poor compliance
- if they suffering from any chronic or long lasting illness
- abuse of alcohol or medicine
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 fatAlso: yellow group, Green group45 g milk fat per day in 4 weeks | Dietary supplement | – |
Primary outcome
plasma phytanic acid
Time frame: before and after the intervention (4 weeks)
8 secondary outcomes
total cholesterol
Time frame: before and after the intervention (4 weeks)
LDL cholesterol
Time frame: before and after the intervention (4 weeks)
HDL cholesterol
Time frame: before and after the intervention (4 weeks)
triacylglycerol
Time frame: before and after the intervention (4 weeks)
C-reactive protein
Time frame: before and after the intervention (4 weeks)
insulin
Time frame: before and after the intervention (4 weeks)
glucose
Time frame: before and after the intervention (4 weeks)
fatty acid composition in plasma
Time frame: before and after the intervention (4 weeks)
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 28 Apr 2011.
- Derived from this study: PubMed 21663648Werner LB, Hellgren LI, Raff M, Jensen SK, Petersen RA, Drachmann T, Tholstrup T. Effect of dairy fat on plasma phytanic acid in healthy volunteers - a randomized controlled study. Lipids Health Dis. 2011 Jun 10;10:95. doi: 10.1186/1476-511X-10-95.
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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.
Tine Tholstrup, lector principal investigator
Department of Human Nutrition, University of Copenhagen
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 fat in people with Coronary Heart Disease, run by University of Copenhagen at 1 site in Denmark.
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 5 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 28 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 Denmark. 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?
plasma phytanic acid (time frame: before and after the intervention (4 weeks)). 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 NCT01343576, 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 28 Apr 2011.