13TSB_N4L2FS: Healthy aging using Thixate to Deliver nutrients

该项目将由Eminate的项目经理直接管理。进度将在每月的项目会议上进行审查。项目将被分解为6个工作包，每个工作包都有里程碑和可交付成果（见附录甘特图）。WP1：确定试验的有效成分（4周），该工作包将确定一种可以加载到Thixate系统中的活性成分，这将是一种适用于健康衰老领域的活性模型，可以在临床试验期间进行测量。里程碑：活性鉴定和体外试验。WP2：用有效成分加载Thixate（8周）本工作包将在Eminate实验室中进行，并将确定将有效成分加载到Thixate中的各种方法，里程碑：活性加载和%加载检测。WP3：用于显示加载和发布配置文件（8周）的有效性的体外测试。此工作包也将在Eminate内部进行实验室测试，并将与WP2一起运行。本项目将使用胃模型对加载系统进行测试，并确定最佳加载机制。该WP将显示预期的释放概况，并将用于临床试验的设计。里程碑：选择最佳加载系统，WP4：设计临床试验（4周）。本工作小组将设计一项试验，以证明负载系统对不含噻虫酸酯的安慰剂食品系统的功效。设计阶段将由联合国办事处进行，包括确定分析方法、统计设计和征聘适当的志愿人员。这一阶段还将确保道德审批到位。里程碑：试验设计和招募志愿者。WP5：运行试验（8周）临床试验将在联合国大学大卫格林菲尔德人体生理学部门进行。里程碑：试验结果。WP6：分析结果/计划开发（4周）。这一工作计划将由联合国和联合国海事组织执行。项目团队将分析试验结果，规划该产品的开发、进一步的试验以及可能推出的产品。里程碑：项目报告、开发计划。

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.