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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03105947
First Posted: April 10, 2017
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Broadcasting Corporation
Information provided by (Responsible Party):
Kay-Tee Khaw, University of Cambridge
  Purpose
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.

Condition Intervention
Cardiovascular Risk Factor Other: Coconut oil Other: Butter Other: Olive oil

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

Resource links provided by NLM:


Further study details as provided by Kay-Tee Khaw, University of Cambridge:

Primary Outcome Measures:
  • LDL-Cholesterol [ Time Frame: after 4 weeks of the dietary fat interventions ]
    Blood LDL cholesterol concentrations


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Inflammatory markers [ Time Frame: after four weeks of the dietary fat interventions ]
    Blood inflammatory markers C-Reactive protein


Enrollment: 94
Actual Study Start Date: June 22, 2017
Study Completion Date: August 10, 2017
Primary Completion Date: July 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Butter
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
University of Cambridge
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
University of Cambridge
British Broadcasting Corporation
Investigators
Principal Investigator: Kay-Tee Khaw, MBBChir University of Cambridge
  More Information

Responsible Party: Kay-Tee Khaw, Professor of Clinical Gerontology, University of Cambridge
ClinicalTrials.gov Identifier: NCT03105947     History of Changes
Other Study ID Numbers: 1
First Submitted: April 4, 2017
First Posted: April 10, 2017
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Once trial report published; anticipated March 2018
Access Criteria: Bona fide researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kay-Tee Khaw, University of Cambridge:
lipids
dietary fats