Cardiovascular Risk FactorCOBNCT03105947
Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants
A study testing Coconut oil, Butter and Olive oil in people with Cardiovascular Risk Factor, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from the general community are randomized into one of three arms: participants will be provided with 50 gm extra virgin coconut oil,or 50 grams butter or 50 extra virgin olive oil to be eaten daily for a month. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Coconut oil, Butter and Olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2017to 10 Aug 2017
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the trial of dietary interventions for one month within the age range
Who cannot join
- No known cardiovascular disease: heart disease or stroke; no known cancer; no known diabetes; no use of lipid lowering medication eg. statins; no contraindications to high fat diet e.g. gall bladder or other gastrointestinal condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Coconut Oil, Butter or Olive Oil on Blood Lipids and Metabolic Measures in Healthy Participants
This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from the general community are randomized into one of three arms: participants will be provided with 50 gm extra virgin coconut oil,or 50 grams butter or 50 extra virgin olive oil to be eaten daily for a month. The key outcome is blood low density lipoprotein cholesterol concentrations and secondary outcomes blood lipid profile (total cholesterol, high density lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol difference between the trial arms.
Read the detailed description
This is a randomized trial in which healthy volunteers from the general community are randomized into one of three arms: consumption of 50 gm of extra virgin coconut oil daily OR 50gm of butter daily OR 50gm of extra virgin olive oil daily (50gm is about 2 ounces, or 2 table spoons), to be consumed over a one month period.
The research participants will be recruited from the general community through advertising (BBC).
After full informed consent, participants will attend an assessment visit and have a baseline measures of weight, height, waist circumference, blood pressure, a blood sample for assessment of blood lipids and other metabolic markers, and fill in a health questionnaire and dietary questionnaire. Participants will be randomly allocated to one of three arms: coconut oil, butter or olive oil and will be given supplies of these (portioned, or with measuring spoons) with information about daily consumption of 50 gram of one of these fats.
After one month, participants will return for follow up assessment which will include a repeat blood sample, anthropometric measures and blood pressure, and questionnaire.
Blood samples collected by venepuncture will be stored at the University of Cambridge and analysed at the Department of Clinical Biochemistry, Cambridge University Addenbrooke's Hospital.
At the end of the study, all participants will be given the individual participant results of the anthropometric measures and lipid profiles at baseline and follow up as well as the overall findings of the trial.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Coconut oil, Butter, Olive oil
- Keywords
- lipids, dietary fats
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilOther
50g extravirgin coconut oil daily for four weeks
ButterOther
50g butter daily for four weeks
Olive oilOther
50g extra virgin olive oil daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Coconut oil | Active comparator | 50g extra virgin coconut oil to be consumed daily for four weeks Receives: Other: Coconut oil |
| Butter | Active comparator | 50g butter to be consumed daily for four weeks Receives: Other: Butter |
| Olive Oil | Active comparator | 50g extra virgin olive oil to be consumed daily for four weeks Receives: Other: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-Cholesterol
Blood LDL cholesterol concentrations
Measured: after 4 weeks of the dietary fat interventions
Secondary outcomes (6)
triglycerides
Blood triglycerides
Measured: after 4 weeks of the dietary fat interventions
HDL-Cholesterol
blood HDL-Cholesterol
Measured: after 4 weeks of the dietary fat interventions
total cholesterol
blood total Cholesterol
Measured: after 4 weeks of the dietary fat interventions
weight
weight
Measured: after four weeks of the dietary fat interventions
waist circumference
Waist circumference
Measured: after four weeks of the dietary fat interventions
Systolic Blood pressure
systolic blood pressure
Measured: after four weeks of the dietary fat interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start22 Jun 2017
- Primary completion27 Jul 2017
- Study completion10 Aug 2017
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 Risk FactorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial of different dietary fats
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- British Broadcasting Corporation
- Responsible party
- Principal investigator, Kay-Tee Khaw, University of Cambridge
- Investigators
- Kay-Tee Khaw, MBBChir, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105947
- Sponsor's protocol ID
- 1
- Acronym
- COB
- Status last verified
- Oct 2017
- First submitted
- 4 Apr 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised IPD data from the trial will be available at the end of the study with publication of the results, through contact with the principal investigator
Publications
Khaw KT, Sharp SJ, Finikarides L, Afzal I, Lentjes M, Luben R, Forouhi NG. Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women. BMJ Open. 2018 Mar 6;8(3):e020167. doi: 10.1136/bmjopen-2017-020167.
PubMed 29511019
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Coconut Oil, Butter or Olive Oil on Blood Lipids and Metabolic Measures in Healthy Participants
- ClinicalTrials.gov ID
- NCT03105947
- Acronym / sponsor ID
- COB / 1
- Conditions
- Cardiovascular Risk Factor
- Keywords
- lipids, dietary fats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- British Broadcasting Corporation
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 10 Apr 2017 (actual)
- 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.
This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from the general community are randomized into one of three arms: participants will be provided with 50 gm extra virgin coconut oil,or 50 grams butter or 50 extra virgin olive oil to be eaten daily for a month. The key outcome is blood low density lipoprotein cholesterol concentrations and secondary outcomes blood lipid profile (total cholesterol, high density lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol difference between the trial arms.
Detailed description
This is a randomized trial in which healthy volunteers from the general community are randomized into one of three arms: consumption of 50 gm of extra virgin coconut oil daily OR 50gm of butter daily OR 50gm of extra virgin olive oil daily (50gm is about 2 ounces, or 2 table spoons), to be consumed over a one month period.
The research participants will be recruited from the general community through advertising (BBC).
After full informed consent, participants will attend an assessment visit and have a baseline measures of weight, height, waist circumference, blood pressure, a blood sample for assessment of blood lipids and other metabolic markers, and fill in a health questionnaire and dietary questionnaire. Participants will be randomly allocated to one of three arms: coconut oil, butter or olive oil and will be given supplies of these (portioned, or with measuring spoons) with information about daily consumption of 50 gram of one of these fats.
After one month, participants will return for follow up assessment which will include a repeat blood sample, anthropometric measures and blood pressure, and questionnaire.
Blood samples collected by venepuncture will be stored at the University of Cambridge and analysed at the Department of Clinical Biochemistry, Cambridge University Addenbrooke's Hospital.
At the end of the study, all participants will be given the individual participant results of the anthropometric measures and lipid profiles at baseline and follow up as well as the overall findings of the trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized trial of different dietary fats
| Arm | Type | Receives |
|---|---|---|
| Coconut oil | Active comparator | Other: Coconut oil50g extra virgin coconut oil to be consumed daily for four weeks |
| Butter | Active comparator | Other: Butter50g butter to be consumed daily for four weeks |
| Olive Oil | Active comparator | Other: Olive oil50g extra virgin olive oil to be consumed daily for four weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Willing to participate in the trial of dietary interventions for one month within the age range
Key exclusion criteria (1 listed)
- No known cardiovascular disease: heart disease or stroke; no known cancer; no known diabetes; no use of lipid lowering medication eg. statins; no contraindications to high fat diet e.g. gall bladder or other gastrointestinal condition
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 |
|---|---|---|
| Coconut oil50g extravirgin coconut oil daily for four weeks | Other | Coconut oil |
| Butter50g butter daily for four weeks | Other | Butter |
| Olive oil50g extra virgin olive oil daily for four weeks | Other | Olive Oil |
Primary outcome
LDL-Cholesterol
Time frame: after 4 weeks of the dietary fat interventions
Blood LDL cholesterol concentrations
6 secondary outcomes
triglycerides
Time frame: after 4 weeks of the dietary fat interventions
HDL-Cholesterol
Time frame: after 4 weeks of the dietary fat interventions
total cholesterol
Time frame: after 4 weeks of the dietary fat interventions
weight
Time frame: after four weeks of the dietary fat interventions
waist circumference
Time frame: after four weeks of the dietary fat interventions
Systolic Blood pressure
Time frame: after four weeks of the dietary fat interventions
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 27 Oct 2017.
- Derived from this study: PubMed 29511019Khaw KT, Sharp SJ, Finikarides L, Afzal I, Lentjes M, Luben R, Forouhi NG. Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women. BMJ Open. 2018 Mar 6;8(3):e020167. doi: 10.1136/bmjopen-2017-020167.
- Individual participant dataSharing planned: Yes. Anonymised IPD data from the trial will be available at the end of the study with publication of the results, through contact with the principal investigator
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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.
Kay-Tee Khaw, MBBChir principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut oil, Butter and Olive oil in people with Cardiovascular Risk Factor, run by University of Cambridge at 1 site in United Kingdom.
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 1 inclusion and 1 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 27 Oct 2017. 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 United Kingdom. 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?
LDL-Cholesterol (time frame: after 4 weeks of the dietary fat interventions). 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 NCT03105947, 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 27 Oct 2017.