AtherosclerosisNCT02116829
Is There Room for Butter in a Healthy Diet?
A study testing Danish butter and Olive oil in people with Atherosclerosis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to examine the effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols). The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Danish butter and Olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Dec 2013
- 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 y
- BMI: 18.5 - 32 kg/m2
- Healthy men and women (with no known diseases)
Who cannot join
- Current or previously cardiovascular disease, high blood pressure
- Diabetes Mellitus or other severe chronic disease, including severe allergies
- Use of dietary supplements and blood donations prior to, and during the study
- Known or suspected abuse of alcohol, drugs or medication
- Pregnant or are planning pregnancy during the study period
- Extreme physical activity level (more than 10 hours tough physical activity pr. week)
- Participation in other research studies
- Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958
About this study
Official title: Is There Room for Butter in a Healthy Diet? - A Randomized Controlled Dietary Human Intervention
The aim of this study is to examine the effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols).
The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well as the inflammatory marker hs-CRP.
- Conditions
- Atherosclerosis
- Being tested
- Danish butter, Olive oil
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danish butterOther
Also called butter, diary
The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)
Olive oilOther
| Study group | Role | What they receive |
|---|---|---|
| Danish butter, dairy | Experimental | Not described Receives: Other: Danish butter |
| Olive oil, refined | Active comparator | Not described Receives: Other: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Measured: 5 weeks
LDL cholesterol
Measured: 5 weeks
HDL cholesterol
Measured: 5 weeks
Triglycerides
Measured: 5 weeks
Secondary outcomes (3)
Insulin
Measured: 5 weeks
Glucose
Measured: 5 weeks
hs-CRP
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
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 AtherosclerosisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Tine Tholstrup, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116829
- Sponsor's protocol ID
- A309
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Engel S, Tholstrup T. Butter increased total and LDL cholesterol compared with olive oil but resulted in higher HDL cholesterol compared with a habitual diet. Am J Clin Nutr. 2015 Aug;102(2):309-15. doi: 10.3945/ajcn.115.112227. Epub 2015 Jul 1.
PubMed 26135349
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Room for Butter in a Healthy Diet? - A Randomized Controlled Dietary Human Intervention
- ClinicalTrials.gov ID
- NCT02116829
- Acronym / sponsor ID
- A309
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Apr 2014 (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 the effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols).
The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well as the inflammatory marker hs-CRP.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Danish butter, dairy | Experimental | Other: Danish butter |
| Olive oil, refined | Active comparator | Other: Olive oil |
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 y
- BMI: 18.5 - 32 kg/m2
- Healthy men and women (with no known diseases)
Key exclusion criteria (8 listed)
- Current or previously cardiovascular disease, high blood pressure
- Diabetes Mellitus or other severe chronic disease, including severe allergies
- Use of dietary supplements and blood donations prior to, and during the study
- Known or suspected abuse of alcohol, drugs or medication
- Pregnant or are planning pregnancy during the study period
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 |
|---|---|---|
| Danish butterAlso: butter, diaryThe effect of butter intake versus olive oil (refined) intake on blood lipids (primarily) | Other | Danish butter, dairy |
| Olive oil | Other | Olive oil, refined |
Primary outcome
Total cholesterol
Time frame: 5 weeks
LDL cholesterol
Time frame: 5 weeks
HDL cholesterol
Time frame: 5 weeks
Triglycerides
Time frame: 5 weeks
3 secondary outcomes
Insulin
Time frame: 5 weeks
Glucose
Time frame: 5 weeks
hs-CRP
Time frame: 5 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 17 Apr 2014.
- Derived from this study: PubMed 26135349Engel S, Tholstrup T. Butter increased total and LDL cholesterol compared with olive oil but resulted in higher HDL cholesterol compared with a habitual diet. Am J Clin Nutr. 2015 Aug;102(2):309-15. doi: 10.3945/ajcn.115.112227. Epub 2015 Jul 1.
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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
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 Danish butter and Olive oil in people with Atherosclerosis, 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 8 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 17 Apr 2014. 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?
Total cholesterol (time frame: 5 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 NCT02116829, 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 17 Apr 2014.