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

NCT03401281 | Unknown

• 1 other identifier: GK001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (1)

• LDL-Cholesterol

  Blood LDL cholesterol concentrations

  4 weeks

Secondary Outcomes (3)

• Triglycerides

  4 weeks

• HDL cholesterol

  4 weeks

• Total Cholesterol

  4 weeks

Study Arms (3)

Coconut oil

ACTIVE COMPARATOR

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

Other: Coconut oil

Butter

ACTIVE COMPARATOR

50g Butter to be consumed daily for four weeks

Other: Butter

Olive oil

ACTIVE COMPARATOR

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

Other: Olive oil

Interventions

Coconut oil OTHER

50g extra virgin coconut oil daily for four weeks

Coconut oil

Butter OTHER

50g butter daily for four weeks

Butter

Olive oil OTHER

50g extra virgin olive oil daily for four weeks

Olive oil

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading

Reading, Please Select, RG6 6UR, United Kingdom

Location

MeSH Terms

Interventions

Coconut Oil; Butter; Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fats, Unsaturated; Fats, Unsaturated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Fats will be embedded in processed cheese - extend of masking will be assessed in sensory study
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Nutrition and Health

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)