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

NCT03105947 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 94
• 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 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

Cardiovascular Risk Factor

Keywords

lipids; dietary fats

Outcome Measures

Primary Outcomes (1)

• LDL-Cholesterol

  Blood LDL cholesterol concentrations

  after 4 weeks of the dietary fat interventions

Secondary Outcomes (6)

• triglycerides

  after 4 weeks of the dietary fat interventions

• HDL-Cholesterol

  after 4 weeks of the dietary fat interventions

• total cholesterol

  after 4 weeks of the dietary fat interventions

• weight

  after four weeks of the dietary fat interventions

• waist circumference

  after four weeks of the dietary fat interventions

Other Outcomes (1)

• Inflammatory markers

  after four weeks of the dietary fat interventions

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 extravirgin 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 Cambridge: lead
• British Broadcasting Corporation: collaborator

Study Sites (1)

University of Cambridge

Cambridge, CB2 2QQ, United Kingdom

Location

Related Publications (1)

• Khaw KT, Sharp SJ, Finikarides L, Afzal I, Lentjes M, Luben R, Forouhi NG. Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women. BMJ Open. 2018 Mar 6;8(3):e020167. doi: 10.1136/bmjopen-2017-020167.

  PMID: 29511019 DERIVED

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 Officials

• Kay-Tee Khaw, MBBChir

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Gerontology

Model Details: Randomized trial of different dietary fats

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: June 22, 2017
• Primary Completion: July 27, 2017
• Study Completion: August 10, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Once trial report published; anticipated March 2018
• Access Criteria: Bona fide researchers

Locations

GB (1)