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

Cardiovascular Risk Factor Clinical Trial

— COB  

Official title:

Randomized Trial of Coconut Oil, Butter or Olive Oil on Blood Lipids and Metabolic Measures in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105947
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: October 26, 2017
• Start date: June 22, 2017
• Est. completion date: August 10, 2017

Study information

• Verified date: October 2017
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 10, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Other:
• Coconut oil
50g extravirgin coconut oil daily for four weeks
• Butter
50g butter daily for four weeks
• Olive oil
50g extra virgin olive oil daily for four weeks

Locations

Country	Name	City	State
United Kingdom	University of Cambridge	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
University of Cambridge	British Broadcasting Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory markers	Blood inflammatory markers C-Reactive protein	after four weeks of the dietary fat interventions
Primary	LDL-Cholesterol	Blood LDL cholesterol concentrations	after 4 weeks of the dietary fat interventions
Secondary	triglycerides	Blood triglycerides	after 4 weeks of the dietary fat interventions
Secondary	HDL-Cholesterol	blood HDL-Cholesterol	after 4 weeks of the dietary fat interventions
Secondary	total cholesterol	blood total Cholesterol	after 4 weeks of the dietary fat interventions
Secondary	weight	weight	after four weeks of the dietary fat interventions
Secondary	waist circumference	Waist circumference	after four weeks of the dietary fat interventions
Secondary	Systolic Blood pressure	systolic blood pressure	after four weeks of the dietary fat interventions