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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 syndrome obtained with herbal extracts)

Teaser

Summary

After a four-year program of research and development, MONTELOEDER has identified highly active components in well-known and safe herbal extracts (Hibiscus sabdariffa and Lemon verbena), that preclinical results shows to modulate triglyceride accumulation, oxidative stress and inflammation in insulin-resistant adipocytes and their capacity to decrease body weight, serum cholesterol and triglycerides levels and hepatic steatosis signs in a hyperlipidemic mouse model subjected to high-fat diets.

The company will put in the market a natural functional food ingredient, based on the selected combinations of two herbal extracts that exhibit synergy in their ability to activate AMPK â€“enzyme, for the treatment and prevention of overweight and conditions associated with Metabolic Syndrome.

The specific objectives of the project are:

â€¢ Develop and place on the market a novel environmentally friendly natural functional food ingredient, clinically proven, for the treatment and prevention of overweight and conditions associated with Metabolic Syndrome.
â€¢ Plan and execute of clinical studies for the scientific substantiation of EFSA health claim. Develop claim strategies, especially with respect to the scientific requirements of for the substantiation of health claims. The publication of the authorized health claims list is an opportunity for our communication on the Nutrition and Health market and is also a challenge for industrials using unauthorized health claim
â€¢ Ingredient will be develop to be applied in the field of functional food so it will be necessary design functional foods with our bioactive ingredient, preferentially in milk and dairy products, beverages, juice and food supplements

To achieve those general objectives, MONTELOEDER has worked in Phase I, in a wide feasibity study â€“according to the Work Plan Submitted in the Proposal - which includes Technical, Commercial, Productive and Economical parameters.

The objective of this Phase I is to analyze and study the technical, legal and industrial parameters, to elucidate the best commercialization and marketing strategy for METABOL AID (name that has been given to the mixture of natural Herbs), in order to prepare for EUâ€™s market uptake, and evaluate reaching non-EU countriesâ€™ market.

To achieve those general objectives, MONTELOEDER has worked in a wide feasibility study, which includes Technical, Commercial, Productive and Economical parameters. During this Phase I the Company has analyzed and studied the technical, legal and industrial parameters, to elucidate the best commercialization and marketing strategy for METABOL AID (name that has been given to the mixture of natural Herbs), in order to prepare for EUâ€™s market uptake, and evaluate reaching non-EU countriesâ€™ market..

Work performed

The Phase I proposed work program, accomplished during July to October 2015, and the main results achieved are presented below:

TASK 1.1 â€“ TECHNICAL FEASIBILITY STUDY:

During the Phase I, an efficacy of the selected formulation has been tested in a proof-of-concept human trial in light-to-moderate overweight volunteers. The trial is double-blind and placebo-controlled and has been conducted in the Miguel HernÃ¡ndez University from Elche (Spain), and carried out by doctors and expert nutritionists in accordance with the ethical principles for medical research.

The results has shown that the consumption of 500 mg/day MetabolAidÂ® for two months in overweight women:

- Improvement of anthropometric parameters: Higher reductions of body weight (4 Kg), waist circumference (5.6 cm) and percentage of body fat (4.8 %) compared to the placebo group.
- Improvement of blood pressure: Greater decrease in the heart rate (80 to 71) and systolic blood pressure (128.4 to 111.9 mm Hg) compared to the placebo group.
- Improvement in the Blood lipid profile: Higher reductions in total cholesterol (231.2 to 203.9 mg/dl) and LDL cholesterol (155.5 to 126.58 mg/dl) compared to the placebo group.
- Higher decrease of blood sugar level (93.4 to 90.3 mg/dl) compared to the placebo group.

In conclusion, the consumption of 500 mg/day of MetabolAidÂ® in combination to isocaloric diet may be considered as a dietary supplement for weight management and the prevention of metabolic syndrome.
For Phase II, new Technical Objectives have been established, as follow:

TASK 1.2 â€“ INDUSTRIAL FEASIBILITY STUDY:

One of the important aspect that MONTELOEDER have studied in Phase I is the manufacturing proposal, including the herbs extraction (Lemon verbena and Hibiscus flower), the final mixture to obtain METABOL AID, the annual production capacity, the costs structure and the facilities and investments needed.

Regarding the herbs extraction, according to the MONTELOEDER priorities and internal evaluation, two are the suppliers selected to start with the industrial experiment in PHASE II. If the industrial scale experiment goes well with the two supplier selected, they will manufacture the ingredients separately as explained later.

1.-) NUTRAFUR S.A. is a world leader in developing, manufacturing and marketing natural plant extracts. The company has an area for industrial use of 80.000 m2 and includes two production plants equipped with the latest extraction technology. Nutrafur could manufacture more than 24 Tons per year of each raw material of MetabolAid. Minimum capacity 2 Tn/month.

2.-) ESPECIALIDADES FARMACÃ‰UTICAS CENTRUM S.A., extracting plant in Succina (Murcia) is a manufacturing of natural ingredients (solid, semi-solid and liquid extracts) from plants using healthy raw materials and environmentally friendly processes. The company could manufacture more than 12 Tons per year of each raw material of MetabolAid. Minimum capacity 1 Tn/month.

TASK 1.3 â€“ COMMERCIAL FEASIBILITY STUDY:

During the last four months, MONTELOEDER have been working with INVENIERE (www.invenire.fi) to explore the current competition, substitutes and overall demand to obtain a Market and competitive analysis for METABOL AID in E.U. and International environment. Next, the main results of the Market research are summarized:

Markets Segments: HealthFocusÂ® has identified five primary benefit platforms for positioning health and nutrition products to shoppers. Virtually any functional product can be positioned against any one or a combination of these benefits:

â€¢ Prevention. Foods that provide health management through disease and symptom prevention fall into this category.
â€¢ Performance. A product that provides health enhancement through improved physical and mental condition.
â€¢ Wellness. Wellness benefits are about feeling good and finding balance.
â€¢ Nurturing. Foods that can supply a sense of caring f

Final results

MONTELOEDER INTERNAL IMPACT

- Based on the Feasibility Economic Study, MONTELOEDER would double its Turnover after 4 years from the start of the sales, and would also increment staff at least in 7-10 people.
- Improved company image, difficult to assess. This improvement is not only important in relation to customers, institutions and the market in general, but would also have a positive impact on the company\'s own workers, that would be materialized in an exciting future.
- Entering new markets, resulting in new ways and channels of commercial distribution. This, could result in the potential introduction of other commercial products of MONTELODER SL for new clients or costumers.
- Improve the overall profitability of the company, which could affect new investments in R & D, production, structural, and improving economic conditions and labour\'s own staff.

METABOL AID MARKET AND SOCIO ECONOMIC IMPACT

Metabolic Syndrome is a result of unhealthy lifestyle habits. Lifestyle changes are difficult to apply and generally people donâ€™t take action without a wakeup call. Therefore, the opportunity for MetS products is not that much in the preventative side, but rather fixing the problems quickly to revert back to better health. Therefore, active reduction as well as evident and measurable results are crucial for a solution to deliver trusted results.

Success on the projectâ€™s targets will affect directly to decisive European Policies such as Health and well-being of European citizens; Decrease of Health Care expenses; Lowering of environmental impact by using food ingredient production compatible processes; Food safety and quality.

Typical customers within dietary supplements: typical customers for co-branded ready consumer products (in supplement category) tend to be small and medium sized companies as many big consumer brands want to have their own brands. They can be either pure distributors or companies having also their own brands. Customer list depends on the business model and overall offer. The list provided in the market research report serves as an example of such companies who are taking on ready concepts with focus on natural plant based products.

Typical customers within food and drinks: For MetS food or beverage product the typical next step customer could be e.g. a specialised distributor for particular sales channel (ie. also serving other channels than main supermarkets). As Kyolic concept works as a reference point, the focus is on dietary supplement customers.