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

Study Overview
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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 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
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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 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.

Official Title
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Randomised Trial of Different Dietary Fat Sources on Blood Lipids and Other CVD Risk Factors in Health Men and Women

Conditions
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Dietary Modification

Intervention / Treatment
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* Other: Coconut oil
* Other: Butter
* Other: Olive oil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coconut oil<br>50g extra virgin coconut oil to be consumed daily for four weeks | Other: Coconut oil<br>* 50g extra virgin coconut oil daily for four weeks<br>|
| Active Comparator: Butter<br>50g Butter to be consumed daily for four weeks | Other: Butter<br>* 50g butter daily for four weeks<br>|
| Active Comparator: Olive oil<br>50g extra virgin olive oil to be consumed daily for four weeks | Other: Olive oil<br>* 50g extra virgin olive oil daily for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-Cholesterol | Blood LDL cholesterol concentrations | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | Blood triglycerides | 4 weeks | 
| HDL cholesterol | Blood HDL cholesterol | 4 weeks | 
| Total Cholesterol | Total Blood Cholesterol | 4 weeks |