Clinical trial NCT03105947: Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants
Official title: Randomized Trial of Coconut Oil, Butter or Olive Oil on Blood Lipids and Metabolic Measures in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: lipids
dietary fats
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: British Broadcasting Corporation
First posted: 2017-04-10
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial of different dietary fats
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL-Cholesterol
timeFrame: after 4 weeks of the dietary fat interventions
Secondary outcomes:
measure: triglycerides
timeFrame: after 4 weeks of the dietary fat interventions
measure: HDL-Cholesterol
timeFrame: after 4 weeks of the dietary fat interventions
measure: total cholesterol
timeFrame: after 4 weeks of the dietary fat interventions
measure: weight
timeFrame: after four weeks of the dietary fat interventions
measure: waist circumference
timeFrame: after four weeks of the dietary fat interventions
measure: Systolic Blood pressure
timeFrame: after four weeks of the dietary fat interventions
Other outcomes:
measure: Inflammatory markers
timeFrame: after four weeks of the dietary fat interventions
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge
Study officials:
affiliation: University of Cambridge
name: Kay-Tee Khaw, MBBChir
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.