Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants (COB)
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|ClinicalTrials.gov Identifier: NCT03105947|
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Factor||Other: Coconut oil Other: Butter Other: Olive oil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized trial of different dietary fats|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The primary outcome will be blood LDL-cholesterol, secondary outcomes, lipid profile which will be measured in a biochemistry lab by individuals who have no knowledge of the allocation to intervention arms.|
|Official Title:||Randomized Trial of Coconut Oil, Butter or Olive Oil on Blood Lipids and Metabolic Measures in Healthy Participants|
|Actual Study Start Date :||June 22, 2017|
|Actual Primary Completion Date :||July 27, 2017|
|Actual Study Completion Date :||August 10, 2017|
Active Comparator: Coconut oil
50g extra virgin coconut oil to be consumed daily for four weeks
Other: Coconut oil
50g extravirgin coconut oil daily for four weeks
Active Comparator: Butter
50g butter to be consumed daily for four weeks
50g butter daily for four weeks
Active Comparator: Olive Oil
50g extra virgin olive oil to be consumed daily for four weeks
Other: Olive oil
50g extra virgin olive oil daily for four weeks
- LDL-Cholesterol [ Time Frame: after 4 weeks of the dietary fat interventions ]Blood LDL cholesterol concentrations
- triglycerides [ Time Frame: after 4 weeks of the dietary fat interventions ]Blood triglycerides
- HDL-Cholesterol [ Time Frame: after 4 weeks of the dietary fat interventions ]blood HDL-Cholesterol
- total cholesterol [ Time Frame: after 4 weeks of the dietary fat interventions ]blood total Cholesterol
- weight [ Time Frame: after four weeks of the dietary fat interventions ]weight
- waist circumference [ Time Frame: after four weeks of the dietary fat interventions ]Waist circumference
- Systolic Blood pressure [ Time Frame: after four weeks of the dietary fat interventions ]systolic blood pressure
- Inflammatory markers [ Time Frame: after four weeks of the dietary fat interventions ]Blood inflammatory markers C-Reactive protein
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105947
|University of Cambridge|
|Cambridge, United Kingdom, CB2 2QQ|
|Principal Investigator:||Kay-Tee Khaw, MBBChir||University of Cambridge|