Trial of Different Dietary Fat Sources on Blood Lipids and Other CVD Risk Factors

Not Applicable

• Conditions: Dietary Modification
• Interventions: Other: Butter; Other: Coconut oil; Other: Olive oil

• Registration Number: NCT03401281
• Lead Sponsor: University of Reading

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 food will be provided in the form of processed cheese to mask participants. 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 food will be provided in the form of processed cheese to mask participants.

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

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 venipuncture will be stored at the University of Reading.

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 Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Last Update Submitted: 2018-01-16
• Study First Posted: 2018-01-17
• Last Update Posted: 2018-01-17
• Study Start: 2018-04-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butter	Butter	50g Butter to be consumed daily for four weeks
Coconut oil	Coconut oil	50g extra virgin coconut oil to be consumed daily for four weeks
Olive oil	Olive oil	50g extra virgin olive oil to be consumed daily for four weeks

Primary Outcome Measures

Name	Time	Method
LDL-Cholesterol	4 weeks	Blood LDL cholesterol concentrations

Secondary Outcome Measures

Name	Time	Method
HDL cholesterol	4 weeks	Blood HDL cholesterol
Total Cholesterol	4 weeks	Total Blood Cholesterol
Triglycerides	4 weeks	Blood triglycerides

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, Please Select, United Kingdom