None listed
Conditions
Brief summary
Cardiovascular disease (CVD) is the leading cause of death worldwide.Two major risk factors for CVD are high levels of blood cholesterol and inflammation. It is well known that dietary supplementation with foods enriched with plant sterols lower cholesterol levels by 10% in 3 weeks. It is also known that curcumin (found in tumeric) has anti-inflammatory properties. This project aims to investigate if combined dietary supplementation with plant sterols and curcumin reduces blood cholesterol and inflammation to a larger extent than either of the treatments alone.It is expected that participants will have improved levels of blood cholesterol, fatty acids and markers of inflammation as well as an overall reduced 10-year risk of developing CVD. The findings of this research could translate to wider public health benefits through the development of a single functional food that combines both phytosterols and curcumin (e.g. margarine spread or reduced-fat milk). This could be easily incorporated into the regular diet of the general Australian adult population in order to minimise the risk of developing cardiovascular disease.
Interventions
The effects of dietary supplementation of 2.0g of phytosterols (phytosterol-enriched margarine) with or without curcumin (capsules) each day. This randomised control trial is a 2x2 factorial placebo-controlled design.
Hypercholesterolaemic individuals will be randomly assigned to one of the following treatment arms for 4 weeks:
Arm 1: Placebo: 25g Regular canola-based margarine spread plus placebo (2 x 500mg capsules) per day.
Arm 2: 25g Logicol margarine spread (i.e. 2g phytosterols) plus place
The effects of dietary supplementation of 2.0g of phytosterols (phytosterol-enriched margarine) with or without curcumin (capsules) each day. This randomised control trial is a 2x2 factorial placebo-controlled design. Hypercholesterolaemic individuals will be randomly assigned to one of the following treatment arms for 4 weeks: Arm 1: Placebo: 25g Regular canola-based margarine spread plus placebo (2 x 500mg capsules) per day. Arm 2: 25g Logicol margarine spread (i.e. 2g phytosterols) plus placebo (2 x 500mg capsules) per day. Arm 3: 25g Regular canola-based margarine spread plus Curcumin (2 x 500mg capsules) per day. Arm 4: 25g Logicol margarine spread (i.e. 2g phytosterols) and Curcumin (2x 500mg capsules) per day. The margarine will be pre-weighed into individual containers containing the daily dosage and all of the daily dose of margarine (i.e. 25g) is to be consumed. Participants will be instructed on how to consume the margarine at their initial visit to the research clinic. The margarine is to be consumed as a regular margarine or butter spread would normally be used (i.e. spread on bread, crackers, muffins etc) however, not used for cooking or melted on top of vegetables. To assess compliance: 1. Participants will be asked to record their daily consumption of the two intervention products in a standardised log provided to them. 2. Participants will be asked to return all margarine containers and capsule bottles at the end of the trial for record and weighing of any remaining products.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-70 years * Gender: both males and females * Total cholesterol levels greater than or equal to 5.5mmol/L (after a 10 hour fast)
Exclusion criteria
* Pregnant or lactating * History of cardiovascular events (e.g. stroke, heart attack, angina, aneurysm, hemorrhage, myocardial infarction etc) * People with pace maker implants * Diabetes mellitus * A chronic inflammatory disease and/or condition (e.g. cancer) * Hypertension * Liver or renal disease * Taking anti-inflammatory medications/supplements (e.g. Aspirin, Atacand, Celebrex) * Taking hypolipidaemic medications/supplements (e.g. Lipitor, Crestor, Zocor) * Taking regular dietary supplements known to influence blood lipid levels (e.g. fish oil, fibre, curcumin) * Already consuming phytosterol-enriched products on a daily and/or regular basis (approximately 4 days/week) * Strong allergies/intolerance/sensitivities or food aversions to the foods involved in this study * History of gastric ulcers, lung and respiratory diseases * History of severe neurological diseases or seizures * BMI greater than 40
Outcome results
None listed