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

Dietary Modification Clinical Trial

— COCHEESE  

Official title:

Randomised Trial of Different Dietary Fat Sources on Blood Lipids and Other CVD Risk Factors in Health Men and Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03401281
• Other study ID #: GK001
• Status: Not yet recruiting
• Phase: N/A
• First received: January 9, 2018
• Last updated: January 16, 2018
• Start date: April 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: January 2018
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Other:
• Coconut oil
50g extra virgin coconut oil daily for four weeks
• Butter
50g butter daily for four weeks
• Olive oil
50g extra virgin olive oil daily for four weeks

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-Cholesterol	Blood LDL cholesterol concentrations	4 weeks
Secondary	Triglycerides	Blood triglycerides	4 weeks
Secondary	HDL cholesterol	Blood HDL cholesterol	4 weeks
Secondary	Total Cholesterol	Total Blood Cholesterol	4 weeks