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

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 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 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.

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

Conditions
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Cardiovascular Risk Factor

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized trial of different dietary fats
Masking: Single


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 extravirgin 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipids, dietary fats