CClinicalTrials.gg
Status unknownNCT03401281COCHEESEUpdated Jan 17, 2018

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

An interventional study of Coconut oil and Butter in Dietary Modification, sponsored by University of Reading. Status unknown at 1 site in United Kingdom. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by University of Reading · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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 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.

Read the 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 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.

02

Conditions studied

  • Dietary Modification
03

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Willing to participate in the trial of dietary interventions for one month within the age range

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Coconut oil

    50g extra virgin coconut oil to be consumed daily for four weeks

    Other: Coconut oil

  • Active comparator
    Butter

    50g Butter to be consumed daily for four weeks

    Other: Butter

  • Active comparator
    Olive oil

    50g extra virgin olive oil to be consumed daily for four weeks

    Other: Olive oil

Interventions

  • OtherCoconut oil

    50g extra virgin coconut oil daily for four weeks

  • OtherButter

    50g butter daily for four weeks

  • OtherOlive oil

    50g extra virgin olive oil daily for four weeks

05

What researchers measure

Primary outcomes

  1. LDL-Cholesterol

    Blood LDL cholesterol concentrations

    Time frame: 4 weeks

Secondary outcomes

  1. Triglycerides

    Blood triglycerides

    Time frame: 4 weeks

  2. HDL cholesterol

    Blood HDL cholesterol

    Time frame: 4 weeks

  3. Total Cholesterol

    Total Blood Cholesterol

    Time frame: 4 weeks

06

Study locations

1 site
  • University of Reading
    Reading, Please Select RG6 6UR, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03401281
Lead sponsor
University of Reading
Responsible party
Gunter G C Kuhnle (Associate Professor in Nutrition and Health, University of Reading) — Principal investigator
First posted
Jan 17, 2018
Start date
Apr 1, 2018 (estimated)
Primary completion
Oct 1, 2018 (estimated)
Completion
Oct 1, 2018 (estimated)
Last update
Jan 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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