13TSB_N4L2FS: Healthy aging using Thixate to Deliver nutrients

点击翻译按钮获取中文摘要

This project will be directly managed by a project manager within Eminate. Progress will be reviewed at monthly project meetings. The project will be broken down into 6 work packages each with milestone and deliverables (See appendix for Gantt chart). WP1: identify active ingredients for trial (4 weeks), this work package will identify an active ingredient which can be loaded into the Thixate system, This will be a model active which is applicable to the area of healthy aging which can be measured during a clinical trial, Milestone: active identified and assay trialled in vitro.WP2: Load Thixate with active ingredients (8 weeks) This work package will be lab based within Eminate and will identify various methods to load the active ingredient into Thixate, Milestone: active loaded and % loaded assayed.WP3: Invitro tests to show the efficacy of loading and release profile (8 weeks) this work package will also be lab based within Eminate and will run alongside WP2. This WP will test the loading system using a model stomach and identify the best loading mechanism. This WP will show the release profile expected and will feed into the design of the clinical trial. Milestone: best loading system chosen,WP4: Design clinical trial (4 weeks). This WP will design a trial to demonstrate the efficacy of the loaded system against a placebo food system without Thixate. The design stage will be carried out by UoN and will include the identification of assays, statistical design and recruitment of appropriate volunteers. This stage will also ensure that ethical approval is in place. Milestone: trial design and recruited volunteers.WP5: run trial (8weeks) the clinical trial will take place at the David Greenfield Human Physiology Unit in UoN. Milestone: trial results. WP6: Analyse results/plan exploitation (4 weeks). This WP will be carried out by UoN and Eminate. The project team will analyse the trial results and plan the exploitation of this product, further trials to be carried out and the possible launch of a product. Milestone: Project report, exploitation plan.