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Clinical Trial for Functional Foods Structure of a model

Paving a New Way for Development of Functional Foods:The Ebetsu Model for Human Clinical Trial of Foods

To date, it has been widely accepted that clinical trials for evaluation of functionality and safety of foods are time-consuming and costly due to recruitment of volunteers and scarcity of support from research institutes. Thus, only limited food corporations could afford to perform clinical trials. In 2007, under the concept of promotion of Hokkaido as the core of food industry based on scientific evidence, a new project for construction of human clinical trials for foods has been launched in alliance with Sapporo Bio-S, Hokkaido Information University and Ebetsu City. Today, this innovative activity is widely supported by local citizen groups, several medical institutions, and private sector organizations. The concept of this project is designated as “a one-stop solution service of functional food analyses.” In this context, this newly introduced ‘Clinical Trial System’ (Ebetsu Model) has made it possible to carry out various types of clinical trial, ranging from large-scale human clinical intervention to small-size trials customized for small and middle-sized companies.

3 KeyWords Our Purpose of Clinical Trial

01 keyword

Addition of values to agricultural 
and marine products

In Hokkaido, we produce foods containing superior ingredients. We support the verification of added value, and development of highly qualified functional foods.

01 Preparation

Custom-made  clinical trial with
high quality and low cost

Depending on size of budgets for clinical trial, we are able to propose the best schedule to obtain essential information in terms of safety and functionality of functional foods with low costs.

01 Preparation

From functional analysis to clinical trial 
with prompt and efficient procedures

In order to carry out all facets of functional analysis of foodstuffs to clinical trial, all procedures are carried out swiftly and efficiently.

Regional Alliance

Human clinical trial
for functional foods

  • Planning of human clinical trial
  • Formulation of ethics committee
  • Clinical trial intervention
  • Management of volunteers, etc.

Functional analysis &
Clinical examination

  • Functional analysis by cultured cells
  • Hematological examination
  • Biochemical examination
  • Electrocardiogram
  • Abdominal echogram, etc.

Data management

  • Statistical analysis
  • Information management (Management of personal information by an anonymized IT support system)
  • Report generation,etc.