Kale og Broccoli Salat

KLINISK

STUDIE

Foods High in Sulforaphane

Foods High in Sulforaphane

 

Project identification code: QK1910264

Project start and end date: 01/2019 - 12/2022

Objectives of the project solution:

development of a foods high in sulforaphane. Test the effect of sulforaphane-high foods in children with autism spectrum disorder in a clinical double-blind placebo study.

Project Results:

The result of the project should be foods with a high content of sulforaphane. This substance has antimutagenic and anti-carcinogenic effects and therefore has a preventive effect against a number of dangerous diseases. This is known from the literature. However, we want to follow up on the American study to see if eating such foods will help to improve the autistic behavior of people with disabilities.

 

Subject of project design solution:

Investigate the germination process of broccoli seeds and the processing of broccoli sprouts and white radish to create the highest level of sulforaphane content in the final product. Effect of drying, influence of post-drying processing - the criterion of all treatments is the highest content of sulforaphane. Test the effectiveness of consuming foods high in sulforaphane in a clinical double-blind study on people with autism.

 

2. PROJECT INTRODUCTION

2.1. Project objective (purpose of support)

A suitable form of food (food supplements) based on broccoli sprouts and white radish adapted to contain the highest and constant levels of sulforaphane concentration and to be consumed by those suffering from autism. Test of the effect of consuming high sulforaphane foods in children with autism spectrum disorder in a clinical double-blind placebo study.

 

2.5. Necessity and timeliness of the project

Autism reflects the complex disorder of the development of a brain and affects many mental functions, including those that are most characteristic of humans, social behavior and communication. Raising an autistic child for these reasons is extremely difficult. The family often faces social isolation, lack of state support and financial problems as a result of the child's disability. The social impact of an autistic disorder is also very serious. Only 25% of people with autism can function independently or considerably independently in adulthood, while others are dependent on family and state support for life. Although no causal therapy for PAS is known, cases in which autistic features have disappeared with development and / or intervention are increasingly being reported. Any meaningful research into possible causes and interventions is a great promise and hope for a better future for not only people with autism,

Timely, effective intervention and reduction of problem behavior increases the quality of life of people with autism and their families and is a major economic asset that has been proven and quantified by some studies.

The results of the project will be applied in the Czech Republic both in the preparation of sprouts of Czech origin and their processing (lyophilization, grinding, filling of capsules) or the production of other food supplements suitable for a group of people affected by autism

 

2.6. Critical assumptions for achieving project goals and results

- a prerequisite is the preparation of a dietary supplement with a high sulforaphane content, which will be palatable for consumption by patients;

- a prerequisite for a clinical trial is the preparation of a taste-matching placebo;

- A clinical trial is planned for 50 patients divided into treated and untreated groups. The minimum number of patients enrolled in the study would be 30 patients;

- a high incidence of adverse reactions following sulforaphane administration may complicate the clinical study. However, these studies have not been observed so far, so we do not expect them.

 

2.10. Expected benefits of the project

The benefits of applying project results can be a substantial improvement in the behavior of people with autism, which will make it easier for families and carers to work with.

A planned scientific study published in a prestigious impact journal will extend the knowledge of scientists and doctors about the possibility of improving the behavior of people with autism due to consumption of products containing proven doses of sulforaphane. It's about your results.

 

5. PROJECT TEAM ORGANIZATION

5.1. Recipient - [P] Food Research Institute Prague, v.v.i.

Coordination of work, management of team meetings, writing partial and final reports, writing manuscripts articles, utility models, functional samples and proven technologies.

 

5.1. Another participant - [D] Pure Food Norway AS

Vegetable sprouts cultivation and processing technology, industrial processing. Germination, drying and filling of gelatin capsules or tableting of high sulforaphane food.

 

5.1. Another participant - [D] General University Hospital in Prague

Doc. Magner is monitoring a group of about 300 children with autism spectrum disorder. His tasks in the study will include preparation of informed consent, preparation of documents for the Ethics Committee of the First Faculty of Medicine and General Teaching Hospital in Prague and submission of applications to SUKL. Together with Dr. Horova, he will be responsible for recruiting children for the study, the timing and technical organization of the clinical trial itself, monitoring clinical and laboratory changes in the therapy. He will be involved in processing the results and preparing the scientific output of the study

 

5.1. Another participant - [D] Mendel University in Brno - Faculty of Horticulture (Lednice)

Organization of project research activities at MENDELU and coordination of work with other co-research teams. Suggestions and experimental solutions to enriching food sprouts with increased sulforaphane content, interpreting results and delivering outputs. Preparation of documents for interim and final reports.

 

5.1. Another participant - [D] National Institute for Autism, z.ú.

Recruiting children to study

methodology and conducting a psychological part of research

monitoring changes in behavior

communication and coordinating procedures with other research entities

 

5.1. Other participant - [D] Global Change Research Institute AS CR, v. I.

He will be responsible for the development and validation of chemical analysis methods for plants and their extracts. It will process the results from chemical analyzes and prepare the groundwork for the project results (reports, publications) and the solution of the planned partial objectives.