Plant Sterols and Beta-Glucan for Reducing Cardiovascular Disease Risk (Beta-GAPS Trial)

The effects of dietary supplementation with 2g of phytosterols (phytosterol-enriched margarine) with or without 3g oat beta-glucan each day. This randomised control trial is a 2x2 factorial placebo-controlled, double-blinded design. Hypercholesterolaemic individuals will be randomly assigned to one of the following treatment arms for 6 weeks: Arm 1: Placebo-Placebo (PP) Group: 8 small sweet vanilla wholemeal biscuits (no phytosterols, no ß-glucan) per day. Arm 2: ß-Glucan (ßG) Group: 8 sweet vanilla wholemeal biscuits fortified with oat ß-glucan powder (no phytosterols, 3g oat ß-glucan) per day. Arm 3: Phytosterol (PS) Group: 8 sweet vanilla wholemeal biscuits fortified with Logical margarine (2g phytosterols, no ß-glucan) per day. Arm 4: Phytosterol-ß-Glucan Group (ßG-PS) : 8 sweet vanilla wholemeal biscuits fortified with ß-glucan and Logicol margarine (2g phytosterols, 3g oat ß-glucan) per day. Prior to the trial appointments, participants complete consent form and questionnaires (medical, physical and 3-day food diary) as fast overnight (10hours) avoiding vigorous activity and alcohol 24hours prior. Participants will attend two clinic visits (baseline and post-intervention) at the Nutraceuticals Research Program at the University of Newcastle that will take 30 minutes in which anthropometric, blood pressure, questionnaires and fasted blood sample will be collected by the lead investigator (PhD student and Accredited Practising Dietitian). Participants will be given the option to participate in an optional 2-hour blood glucose test meal component which is only at baseline, following straight after the appointment. This component involves 5 finger prick tests at timepoint 0, 30min, 60min, 90min and 120min. The biscuits will be made prior to the study and packaged/sealed and provided to participants along with instructions on how to consume the biscuits at their initial visit to the research clinic. The biscuits are to be consumed by participants in between meals (i.e. snack times) with fluid and a daily biscuit consumption log kept for the duration of the trial. To assess compliance: 1. Participants will be asked to record their daily consumption of the intervention biscuits in a standardised log provided to them. 2. Participants will be asked to return all unused biscuit bags to the study site when they attend their final appointment at the end of the study period. They will be asked to keep any unfinished and empty biscuits and return them at the end of the study.