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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - INNOPREFAT (Natural Food formulation for the prevention and treatment the Obesity and Metabolic Syndromeobtained with herbal extracts)

Teaser

Summary

Obesity is recognized as the pandemic of the 21st century, with over a third of the worldÂ´s population being overweight. Its prevalence has doubled in the last 30 years, and at this rate, half of the population will be overweight or obese by 2030. Being overweight increases the risk to develop other life-threatening health conditions, such as cardiovascular disease, type 2 diabetes, several types of cancers, fatty liver disease, dementias, and more. The combination of factors that increase the risk to develop the aforementioned diseases (overweight, high levels of cholesterol/triglycerides, high blood glucose levels, high blood pressure) is known as Metabolic Syndrome.
We at Monteloeder have designed a botanical branded ingredient called Metabolaid, comprised of hibiscus flower and lemon verbena extracts. Our initial clinical studies have shown that individuals taking Metabolaid while following a controlled diet, lose twice as much weight than with diet alone (Boix-CastejÃ³n M et al, 2018 & Herranz-LÃ³pez M et al, under review). Furthermore, the parameters implicated in Metabolic Syndrome, such as blood pressure, cholesterol/triglycerides and blood glucose levels, decreased significantly after consuming Metabolaid during 2 months.
Monteloeder received a phase I SME instrument H2020 project in 2016 with Metabolaid, which impulsed its pilot production. Now, with the phase II project, the main objective is to place the product into the market. The specific objectives of the project are:
a) Scale up Metabolaid manufacturing to an industrial scale, reaching up to 750 kg of production.
b) Obtain an EFSA health claim with Metabolaid, including performing a clinical trial following EFSA guidelines to meet the scientific and clinical requirements for the claim.
c) Analyze the stability, toxicity levels, and compatibility of Metabolaid with various food matrixes.
d) Secure the Intellectual Property of Metabolaid.
e) Execute a marketing strategy and promote communication to the industry of the properties and benefits of Metabolaid.
f) Design a new method of approach to the customers through a mobile app that helps consumers track their weight loss and intake, as well as design and execute a commercial pilot study with a B2C partner.
Besides these objectives, the European Commission Officer added certain requirements to be completed during the first period of the project:
- Data Protection Procedures
- Open Access to Research Data, according to Articles 29.3
- Human procedures and criteria as according to Ethics Guidelines
- Animal experiment procedures according to Ethics Guidelines

Work performed

Based on the specific objectives, the following results have been achieved so far:
a) Scale-Up
This objective was comprised of three sub-objectives: Ensuring Provision of Raw Materials, Adapting and Conditioning for Industrial-Scale Production, and First Industrial-Scale Production.
Ensuring Provision of Raw Materials: Several providers of raw materials were contacted to assess costs, quantities and quality of hibiscus and lemon verbena. A shortlist of the providers of the best quality raw materials was performed.
Adapting and Conditioning for Industrial-Scale Production: A part of the facility has been conditioned for industrial scaling, while being GMP compliant. New machinery was also purchased.
First Industrial-Scale Production: An industrial scale production of Metabolaid was successfully performed, with 500 kg fabricated.

b) Health Claim
This objective is comprised of 4 sub-objectives: Clinical Trial, Bioavailability and Pharmacokinetics, Pre-constituted file for Health Claim, and Finalized file for Health Claim. The first two points have been performed during the first period of the project.
Clinical Trial: A clinical study is currently ongoing to substantiate an EFSA health claim with Metabolaid. The clinical study is expected to finish during the first trimester of the second period of the project.
Toxicity, bioavailability and pharmacokinetics: Studies have been performed in animal models of experimentation, proving that Metabolaid is bioavailable and detectable in blood, and follows a monocompartimental distribution. Previosly an acute toxicity study was performed in a rodent model where the product was shown to have a LD50 higher than 2000 mg/ Kg b.w

c) Stability and Food Compatibility
This objective is comprised of 4 sub-objectives: Shelf-life, Stability studies, Microencapsulation studies, and Compatibility in Food Matrixes. The latter point is to be performed during the second period of the project.
Shelf-life: initial tests demonstrated that the ingredient is stable after 12 months, at room temperature and hidden from light. Further tests are being performed to confirm shelf-life at 24 months, which will be completed by the first trimester of the second period of the project.
Stability studies: the active components of the ingredient were analysed for stability based on temperature, pH, and solubility. The ingredientÂ´s stability is optimal at room temperature, acidic pH, and highly soluble in water.
Microencapsulation studies: microencapsulation of Metabolaid has been successfully performed in two different matrixes, inulin and maltodextrin.

d) Intellectual Property
MetabolaidÂ´s IP has been protected through the submission of a national patent in Spain, with internationalization being currently in process.

e) Marketing & Communication
This objective is comprised of a Brand Design and Dissemination Plan. This has included the design of MetabolaidÂ´s logo, development of Metabolaid pamphlets reporting the more relevant outputs, a web page and commercial video, e-mail shots, a workshop, promotion in specialized events, and presentation to potential customers. The ingredient has been finalist in Innovation Awards of Food Ingredients Frankfurt 2017 and Vitafoods Europe 2018.

f) Commercial Pilot Study
A consumer journey flow chart has been designed for the commercial pilot test. This has been used for the development of a mobile app for Metabolaid, which is currently in both Google Playstore and Apple Store. A large number of companies have been contacted to present the ingredient and the commercial pilot study designed. It was a challenge for us to finally select a company, mainly due to the time needed to adopt the ingredient into a formula, design the app and pilot study, recruitment, etc. Finally, we have selected as commercial partner a diary company.

Final results

The project has arisen interest in many companies wishing to incorporate both the ingredient as well as the digital solution to their portfolio. Companies are aware that personalization is the key for the future of nutrition and supplementation. Consumers are more health-conscious and knowledgeable, and demand high quality, scientifically validated products with proven effectiveness. Also, they require results that they can feel and see. This is the value of digitalization. Through the mobile app, consumers taking Metabolaid are able to track their progress losing weight, discern how Metabolaid helps them regulate their appetite, as well as offer daily tips towards a healthier lifestyle. In the end, reaching and maintaining a healthy weight is a lifelong goal, but generally it requires important behavioural changes that may seem daunting for consumers. To this end, digital technology is rapidly becoming an increasingly efficient tool to induce behaviour change and promote a healthy lifestyle.