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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Other: Coconut oil; Other: Butter; Other: Olive oil

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 2QQ
    • University of Cambridge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coconut oil; 50g extra virgin coconut oil to be consumed daily for four weeks	Other: Coconut oil; 50g extravirgin coconut oil daily for four weeks
Active Comparator: Butter; 50g butter to be consumed daily for four weeks	Other: Butter; 50g butter daily for four weeks
Active Comparator: Olive Oil; 50g extra virgin olive oil to be consumed daily for four weeks	Other: Olive oil; 50g extra virgin olive oil daily for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-Cholesterol	Blood LDL cholesterol concentrations	after 4 weeks of the dietary fat interventions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
triglycerides	Blood triglycerides	after 4 weeks of the dietary fat interventions
HDL-Cholesterol	blood HDL-Cholesterol	after 4 weeks of the dietary fat interventions
total cholesterol	blood total Cholesterol	after 4 weeks of the dietary fat interventions
weight	weight	after four weeks of the dietary fat interventions
waist circumference	Waist circumference	after four weeks of the dietary fat interventions
Systolic Blood pressure	systolic blood pressure	after four weeks of the dietary fat interventions

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	Blood inflammatory markers C-Reactive protein	after four weeks of the dietary fat interventions

Collaborators and Investigators

• Sponsor: University of Cambridge
• Collaborators: British Broadcasting Corporation
• Investigators: Principal Investigator: Kay-Tee Khaw, MBBChir, University of Cambridge

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): July 27, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: lipids; dietary fats
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: Once trial report published; anticipated March 2018
• IPD Sharing Access Criteria: Bona fide researchers
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No