Trial of Different Dietary Fats on Blood Lipids & Metabolic Measures in

Status Completed

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 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.

Clinical Trial 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 research participants will be recruited from the general community through advertising (BBC).

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 (portioned, or with measuring spoons) with information about daily consumption of 50 gram of one of these fats.

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 venepuncture will be stored at the University of Cambridge and analysed at the Department of Clinical Biochemistry, Cambridge University Addenbrooke's Hospital.

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

Related Conditions & MeSH terms

Cardiovascular Risk Factor

Clinical Trial Details

NCT number	NCT03105947
Study type	Interventional
Source	University of Cambridge
Contact
Status	Completed
Phase	N/A
Start date	June 22, 2017
Completion date	August 10, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Enrolling by invitation	`NCT04253054` - Chinese Multi-provincial Cohort Study-Beijing Project
Completed	`NCT03680638` - The Effect of Antioxidants on Skin Blood Flow During Local Heating	Phase 1
Recruiting	`NCT04481503` - Transthoracic Echocardiography of Ventricular Function of Parturients in Labor
Terminated	`NCT04088240` - Effects of Omega-3 Docosapentaenoic Acid on Lipids and Other Risk Factors for Cardiovascular Disease	N/A
Completed	`NCT03410342` - The Effects of Types of Fruits and Vegetables on Vascular Function	N/A
Completed	`NCT03170752` - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)	N/A
Recruiting	`NCT04231838` - Metabolic Syndrome in Diabetic Smokers Using Cigarettes & Combustion-Free Nicotine Delivery Systems	N/A
Active, not recruiting	`NCT03902431` - Translating the ABCS Into HIV Care	N/A
Terminated	`NCT03517111` - The Impact of a Parenting Intervention on Latino Youth Health Behaviors	N/A
Completed	`NCT04562467` - The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk	Phase 4
Completed	`NCT03429920` - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors	N/A
Completed	`NCT04551872` - RESILIENCE: Personalizing Cardiovascular Health	N/A
Enrolling by invitation	`NCT03314818` - Natural History of Carotid Plaque as Determined by 3D Ultrasound	N/A
Completed	`NCT03060811` - Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults	N/A
Completed	`NCT04279704` - Overcoming Obstacles in Epigenetic Analysis of Human Twins
Completed	`NCT01050205` - The Healthy Lifestyle Project	N/A
Completed	`NCT03570840` - Pediatric Metabolic Syndrome Study
Completed	`NCT03039023` - Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans	N/A
Completed	`NCT03646175` - Choline Supplementation and Cardiovascular Health	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms