Plant sterols and Curcumin for the Prevention of Cardiovascular Disease

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: 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. CONDITION: Cardiovascular disease Hypercholesterolaemia Inflammation PRIMARY OUTCOME: Low‐density lipoprotein cholesterol concentration in blood plasma Total cholesterol concentration in blood plasma SECONDARY OUTCOME: Cardiovascular Disease Risk ‐ using the Framingham cardiovascular disease risk algorithm. Inflammatory mediators (i.e. CRP, fibrinogen, IL‐6, IL‐1beta, IkB, iCAM) 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)
Epistemonikos ID: 1570342a847873838ad1a2d615f83933e1b6fc6c
First added on: Aug 25, 2024