13TSB_N4L2FS: Healthy aging using Thixate to Deliver nutrients
Lead Research Organisation:
University of Nottingham
Department Name: Sch of Biomedical Sciences
Abstract
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.
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.
Technical Summary
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
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
Planned Impact
The project will generate important data on a novel method of optimising micronutrient absorption in a group with potentially marginal nutritional status due to the physiological and food choice changes associated with older age. The proposal has facilitated collaboration between food science, physiology, dietetics and has industrial interest.
The project results will be published in target journals to include American Journal of Clinical Nutrition, Journal of Food Chemistry and will be presented at key academic conferences through the lifetime of the project.
The project results will be published in target journals to include American Journal of Clinical Nutrition, Journal of Food Chemistry and will be presented at key academic conferences through the lifetime of the project.
| Description | When compared with the control snack combination, consumption of the test snack did not appear; • to alter perceived appetite • to reduce postprandial blood glucose concentration • delay the appearance of vitamin C in the serum • reduce the excretion of vitamin C in the urine • increase fasting vitamin C concentration On the basis of these results one must wonder whether the Thixate was forming a gel in the stomach, or it is possible that the amount of Thixate in the product may have been inadequate to affect release of nutrients / delay gastric emptying |
| Exploitation Route | Further work would be needed to develop the gelling of the materials in the stomach to explore whether alterations in absorption rates can be achieved |
| Sectors | Agriculture, Food and Drink |