13TSB_N4L2FS: Healthy aging using Thixate to Deliver nutrients

13TSB_N4L2FS：使用 Thixate 提供营养的健康老龄化

• 批准号: BB/L02148X/1
• 负责人: Ian Macdonald
• 金额: $ 3.84万
• 依托单位: University of Nottingham
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=BB%2FL02148X%2F1
• 关键词: 13TSB_N4L2FS; Healthy; aging; using; Thixate

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.

该项目将由Emate内部的项目经理直接管理。将在每月的项目会议上审查进展情况。该项目将分为6个工作包，每个工作包都有里程碑和可交付成果（甘特表见附录）。WP 1：确定试验的活性成分（4周），该工作包将确定可加载到Thixate系统中的活性成分，这将是适用于健康老化领域的模型活性成分，可在临床试验期间进行测量，里程碑：活性成分的确定和体外试验。WP 2：用活性成分加载Thixate（8周）该工作包将在Emate内基于实验室，并将确定将活性成分加载到Thixate中的各种方法，里程碑：活性加载和%加载分析。WP 3：体外试验显示负载和释放曲线的有效性（8周），该工作包也将在Emate内基于实验室，并将与WP 2一起运行。本WP将使用模型胃测试加载系统，并确定最佳加载机制。该WP将显示预期的释放曲线，并将纳入临床试验的设计。里程碑：选择最佳装载系统，WP 4：设计临床试验（4周）。本WP将设计一项试验，以证明负载系统相对于不含Thixate的安慰剂食物系统的有效性。设计阶段将由UoN进行，包括检测试剂盒的鉴定、统计设计和招募适当的志愿者。这一阶段还将确保道德批准到位。里程碑：试验设计和招募志愿者。WP 5：运行试验（8周）临床试验将在纽约大学的大卫格林菲尔德人类生理学中心进行。里程碑：试验结果。工作方案6：分析结果/计划利用（4周）。该WP将由UoN和Emate执行。项目小组将分析试验结果，并计划开发这一产品，进行进一步试验，并可能推出一种产品。里程碑：项目报告，开发计划。