Randomised Trial of Different Dietary Fat Sources on Blood Lipids and Other CVD Risk Factors in Health Men and Women
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Reading
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- LDL-Cholesterol
Study Overview
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 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Fats will be embedded in processed cheese - extend of masking will be assessed in sensory study
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
Butter
50g Butter to be consumed daily for four weeks
Intervention: Butter (Other)
Olive oil
50g extra virgin olive oil to be consumed daily for four weeks
Intervention: Olive oil (Other)
Coconut oil
50g extra virgin coconut oil to be consumed daily for four weeks
Intervention: Coconut oil (Other)
Outcomes
Primary Outcomes
LDL-Cholesterol
Time Frame: 4 weeks
Blood LDL cholesterol concentrations
Secondary Outcomes
- HDL cholesterol(4 weeks)
- Total Cholesterol(4 weeks)
- Triglycerides(4 weeks)
Investigators
Gunter G C Kuhnle
Associate Professor in Nutrition and Health
University of Reading