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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
Sponsor:
Collaborator:
British Broadcasting Corporation
Information provided by (Responsible Party):
Kay-Tee Khaw, University of Cambridge

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 10, 2017
Last Update Posted Date October 27, 2017
Actual Study Start Date  ICMJE June 22, 2017
Actual Primary Completion Date July 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
LDL-Cholesterol [ Time Frame: after 4 weeks of the dietary fat interventions ]
Blood LDL cholesterol concentrations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 7, 2017)
Inflammatory markers [ Time Frame: after four weeks of the dietary fat interventions ]
Blood inflammatory markers C-Reactive protein
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants
Official Title  ICMJE Randomized Trial of Coconut Oil, Butter or Olive Oil on Blood Lipids and Metabolic Measures in Healthy Participants
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 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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.
Primary Purpose: Other
Condition  ICMJE Cardiovascular Risk Factor
Intervention  ICMJE
  • Other: Coconut oil
    50g extravirgin coconut oil daily for four weeks
  • Other: Butter
    50g butter daily for four weeks
  • Other: Olive oil
    50g extra virgin olive oil daily for four weeks
Study Arms  ICMJE
  • Active Comparator: Coconut oil
    50g extra virgin coconut oil to be consumed daily for four weeks
    Intervention: Other: Coconut oil
  • Active Comparator: Butter
    50g butter to be consumed daily for four weeks
    Intervention: Other: Butter
  • Active Comparator: Olive Oil
    50g extra virgin olive oil to be consumed daily for four weeks
    Intervention: Other: Olive oil
Publications * Khaw KT, Sharp SJ, Finikarides L, Afzal I, Lentjes M, Luben R, Forouhi NG. Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women. BMJ Open. 2018 Mar 6;8(3):e020167. doi: 10.1136/bmjopen-2017-020167.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2017)
94
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2017)
90
Actual Study Completion Date  ICMJE August 10, 2017
Actual Primary Completion Date July 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03105947
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymised IPD data from the trial will be available at the end of the study with publication of the results, through contact with the principal investigator
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Once trial report published; anticipated March 2018
Access Criteria: Bona fide researchers
Responsible Party Kay-Tee Khaw, University of Cambridge
Study Sponsor  ICMJE University of Cambridge
Collaborators  ICMJE British Broadcasting Corporation
Investigators  ICMJE
Principal Investigator: Kay-Tee Khaw, MBBChir University of Cambridge
PRS Account University of Cambridge
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP