Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2017-08-10

Brief Summary

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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

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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

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Cardiovascular Risk Factor

Keywords

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lipids dietary fats

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial of different dietary fats

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The primary outcome will be blood LDL-cholesterol, secondary outcomes, lipid profile which will be measured in a biochemistry lab by individuals who have no knowledge of the allocation to intervention arms.

Study Groups

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Coconut oil

50g extra virgin coconut oil to be consumed daily for four weeks

Group Type ACTIVE_COMPARATOR

Coconut oil

Intervention Type OTHER

50g extravirgin coconut oil daily for four weeks

Butter

50g butter to be consumed daily for four weeks

Group Type ACTIVE_COMPARATOR

Butter

Intervention Type OTHER

50g butter daily for four weeks

Olive Oil

50g extra virgin olive oil to be consumed daily for four weeks

Group Type ACTIVE_COMPARATOR

Olive oil

Intervention Type OTHER

50g extra virgin olive oil daily for four weeks

Interventions

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Coconut oil

50g extravirgin coconut oil daily for four weeks

Intervention Type OTHER

Butter

50g butter daily for four weeks

Intervention Type OTHER

Olive oil

50g extra virgin olive oil daily for four weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willing to participate in the trial of dietary interventions for one month within the age range

Exclusion Criteria

* 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Kay-Tee Khaw

Professor of Clinical Gerontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kay-Tee Khaw, MBBChir

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

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University of Cambridge

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 29511019 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Coconut oil

Coconut oil

Butter

Butter

Olive Oil

Olive oil

Interventions

Coconut oil

Butter

Olive oil

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

British Broadcasting Corporation

University of Cambridge

Responsible Party

Kay-Tee Khaw

Principal Investigators

Kay-Tee Khaw, MBBChir

Locations

University of Cambridge

Countries

References

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.

Other Identifiers

1