Cardiovascular DiseaseNCT01140165
Cheese and Human Health
A study testing cheese in people with Cardiovascular Disease, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter. The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- cheese
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Dec 2011
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign written consent
- Age: 20-70
- BMI: 20-32
- Refrain from dietary supplements and blood donations prior to, and during the study
Who cannot join
- Known or suspected abuse of alcohol, drugs or medication
- Poor compliance
- Current or previously cardiovascular disease
- Diabetes Mellitus or other severe chronic disease, including severe allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention
The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter.
The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance, fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.
- Conditions
- Cardiovascular Disease
- Being tested
- cheese
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cheeseOther
Also called cheese, butter, dairy
the effect of cheese intake versus butter intake on blood lipids (primarily)
| Study group | Role | What they receive |
|---|---|---|
| butter | Active comparator | Danish butter Receives: Other: cheese |
| cheese | Experimental | Not described Receives: Other: cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Measured: 6 weeks
LDL cholesterol
Measured: 6 weeks
HDL cholesterol
Measured: 6 weeks
Triglyceride
Measured: 6 weeks
Secondary outcomes (4)
Insulin
Measured: 6 weeks
Glucose
Measured: 6 weeks
fasting hsCRP
Measured: 6 weeks
Blood pressure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010 (estimated)
- Study completionDec 2011 (estimated)
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 Cardiovascular DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, National Dairy Council
- Investigators
- Tine Tholstrup, PhD, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140165
- Sponsor's protocol ID
- A308
- Status last verified
- Oct 2009
- First submitted
- 4 Jun 2010
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hjerpsted J, Leedo E, Tholstrup T. Cheese intake in large amounts lowers LDL-cholesterol concentrations compared with butter intake of equal fat content. Am J Clin Nutr. 2011 Dec;94(6):1479-84. doi: 10.3945/ajcn.111.022426. Epub 2011 Oct 26.
PubMed 22030228
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention
- ClinicalTrials.gov ID
- NCT01140165
- Acronym / sponsor ID
- A308
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, National Dairy Council
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Jun 2010 (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 this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter.
The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance, fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| butter | Active comparator | Other: cheeseDanish butter |
| cheese | Experimental | Other: cheese |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign written consent
- Age: 20-70
- BMI: 20-32
- Refrain from dietary supplements and blood donations prior to, and during the study
Key exclusion criteria (4 listed)
- Known or suspected abuse of alcohol, drugs or medication
- Poor compliance
- Current or previously cardiovascular disease
- Diabetes Mellitus or other severe chronic disease, including severe allergies
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 |
|---|---|---|
| cheeseAlso: cheese, butter, dairythe effect of cheese intake versus butter intake on blood lipids (primarily) | Other | butter, cheese |
Primary outcome
Total cholesterol
Time frame: 6 weeks
LDL cholesterol
Time frame: 6 weeks
HDL cholesterol
Time frame: 6 weeks
Triglyceride
Time frame: 6 weeks
4 secondary outcomes
Insulin
Time frame: 6 weeks
Glucose
Time frame: 6 weeks
fasting hsCRP
Time frame: 6 weeks
Blood pressure
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
- Derived from this study: PubMed 22030228Hjerpsted J, Leedo E, Tholstrup T. Cheese intake in large amounts lowers LDL-cholesterol concentrations compared with butter intake of equal fat content. Am J Clin Nutr. 2011 Dec;94(6):1479-84. doi: 10.3945/ajcn.111.022426. Epub 2011 Oct 26.
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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, PhD 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 cheese in people with Cardiovascular 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jun 2010. 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?
Results are not available in the source record.
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?
Total cholesterol (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT01140165, 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 9 Jun 2010.