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Natural Food formulation for the prevention and treatment the Obesity and Metabolic Syndrome obtained with herbal extracts

Periodic Reporting for period 2 - INNOPREFAT (Natural Food formulation for the prevention and treatment the Obesity and Metabolic Syndromeobtained with herbal extracts)

Okres sprawozdawczy: 2018-10-01 do 2020-03-31

Obesity is recognized as the pandemic of the 21st century, with over a third of the world´s population being overweight. The combination of factors that increase the risk to develop 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-Castejón M et al, 2018 & Herranz-López M et al, 2019). We have also demonstrated that body fat loss can be achieved by taking Metabolaid in absence of diet (Marhuenda J et al, 2020). Furthermore, the parameters implicated in Metabolic Syndrome, such as blood pressure, cholesterol/triglycerides and blood glucose levels, decreased significantly after consuming Metabolaid during 2-3 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.
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 the development of 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.
Based on the specific objectives, the following results have been achieved:
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.

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.
Clinical Trial: A clinical study has completed, with relevant results for a health claim application in blood pressure.
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.
Pre-constituted file for Health Claim/Finalized File: The pre-constituted file was created based on the clinical trial data, as well as the necessary documentation for its substantiation. From the initial assessment, several aspects had to revised, and a finalized document was created. The finalized file has been sent and is currently under review by EFSA.

c) Stability, Toxicity and Compatibility
This objective is comprised of 4 sub-objectives: Shelf-life, Stability studies, Microencapsulation studies, and Compatibility in Food Matrixes.
Shelf-life: initial tests demonstrated that the ingredient is stable after 24 months, at room temperature, hidden from light and in a dry environment.
Stability studies: the active components of the ingredient were analysed for stability based on temperature, pH, and solubility. The ingredient´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
Metabolaid´s IP has been protected through the submission of a national patent in Spain, with internationalization being currently in process. Several countries have already approved the patent registration. Regarding trademark registration, this is being performed in the major countries that Monteloeder performs its business.

e) Marketing & Communication
This objective is comprised of a Brand Design and Dissemination Plan. This has included the design of Metabolaid´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 and 2020. Also, the company sponsored a sports event, specifically a popular race. An online video campaign was also performed during World Obesity Day in 2019, in collaboration with Fundación Mapfre. Renown participants in the video campaign include professional basketball player Pau Gasol, cardiologist Valentin Fuster, Michelin star chef Dani Garcia and youtuber Willyrex.

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. Finally, we selected as commercial partner a diary company, CLUN. The final product, called Actilac, consisted in a yogurt-based drink containing Metabolaid, and an app with the same name (Actilac) was developed to accompany the users during their journey to lose weight. Extremely positive results and feedback have been received from the participants of the pilot test.
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. The pilot test performed with end-consumers has demonstrated that such a strategy is of great interest for the consumers, and many companies are interested in using this type of approach.