Eugedin Complex® - Totally Natural

Autophagy (or autophagocytosis; from the ancient Greek αὐτόφαγος autóphagos, which means self-devourer “and κύτος kýtos, which means “empty”) is the natural and preserved degradation process of the cell that removes unnecessary or dysfunctional components through a regulated lysosome-dependent mechanism. This means that body cells “cleanse” themselves of all unnecessary or damaged components, o facilitate reintegration through recycling of nutrients needed for vital functions, homeostasis, aging, and development. It promotes the supply of energy to the cells, as well as promotes the elimination of potentially harmful waste. Defects in the autophagy process have been linked to various human diseases, including neurodegeneration and cancer, and interest in modulating autophagy as a potential treatment for these diseases has grown rapidly. The Coronavirus family has been shown to block cellular autophagy processes to avoid their own degradation (Bello-Perez et al. 2020). Indeed, there is a complex and concomitant interaction between Coronavirus and autophagy, as these viruses exploit the molecular mechanism of autophagy avoiding its protective apoptotic drift and the formation of innate cellular immune responses. ? –coronaviruses, for example, do not use the biosynthetic secretory pathway typically used by viruses to leave infected cells but exploit lysosomal trafficking, inhibit the autophagic mechanism and use unconventional cellular exocytosis (Gosh et al. 2020).

Nο, the product cannot be considered a product against the fight of SARS-CoV-2 infections. Supplements are not considered medicines. Dietary supplements are products intended to supplement the diet and increase well-being. They are not medicines and are not intended to treat, diagnose, mitigate, prevent, or cure diseases. Eugedin Complex® is a raw material commercialised to be used alone or in combination with other food supplements.

Eugedin Complex® contains clove essential oil, wheat germ as a source of spermidine and vitamin D. The daily recommended dose of this particular supplement raw material is 2 grams/day, corresponding to 380 micrograms of clove essential oil (304 micrograms of Eugenol), 48 micrograms of Vitamin D (daily admitted dose for food supplements) and 16 micrograms of spermidine.

Clinical trials suggest that there are no known side effects of spermidine. The EU COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023 of 23 July 2018 specifies that the maximum spermidine dosage in a food supplement intended for the adult population, excluding pregnant and lactating women is 6 mg/day. Therefore, the recommended spermidine dose in the mixture (16 micrograms) is much lower to the maximum dosage set by the EC IMPLEMENTING REGULATION 2018/1023. There is no study demonstrating acute toxic effects of eugenol by occupational exposure. The daily recommended dose of Eugedin Complex® as a raw material in a food supplement is 2 grams/day, corresponding to 380 micrograms of clove essential oil (304 micrograms of Eugenol). Clove Esswntial Oil is classified as GRAS (Generally Recognised As Safe) by FDA and is commonly used as a flavoring agent. Its main component Eugenol, has a No Observed Adverse Effect (NOAEL) of 300 mg/kg per day, corresponding to 21 grams/day for an individual weighting 70kg. The use of Eugedin Complex® at the recommended dose is therefore considered to be safe.

Yes, the product is GMO-free and in agreement with Regulations EC 1829/2003 and 1830/2003. The product does not contain, does not derive and is not made up of Genetically Modified Organisms.

Nο, the product cannot be considered vegan. Despite the fact that the Vitamin D used in Eugedin Complex® is vegan and TGD has obtained the necessary certification on it, the rest of the ingredients have not been certified as vegan.

There is a wide European regulatory framework covering the product’s ingredients. The General Food Law Regulation (Regulation EC 178/2002 of the European Parliament and the Council) established the principle and foresaw the creation of an independent body called the European Food Safety Authority (EFSA) with the specific task of providing scientific opinions based on the assessment of health benefits and risks associated with food intake. The Eugedin Complex® product ingredients, notably spermidine and eugenol, fall under two wide categories of EU law regulating their use and specifications. Spermidine is considered a novel food and is therefore regulated under the Novel Foods set of EU regulations and implementing regulations. Eugenol is considered a food flavouring and is therefore regulated under Regulation n. 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods . However, concerning spermidine and eugenol in particular, the European Commission has implemented two Regulations: • Commission Implementing Regulation N. 141/2014 of 13 February 2014 amending Implementing Regulation (EU) N. 540/2011 as regards the conditions of approval of the active substance plant oils/clove oil . • Commission Implementing Regulation (EU) 2020/443 of 25 March 2020 authorizing the change of the specifications of the novel food spermidine-rich wheat germ extract (Triticum aestivum) under Regulation (EU) 2015/2283 of the European Parliament and the Council and amending Commission Implementing Regulation (EU) 2017/2470. Also, the World Health Organization (WHO) has declared eugenol as a non-mutant and generally recognised as safe (GRAS) molecule .

The raw wheat germ feedstock is coming from Molino Naldoni, a 320 years old milling company in Italy with high performance standards. Clove Essential Oil (80% eugenol) is coming from Xeda, the Italian branch of Xeda International.

TGD has filed a patent for the synergetic effect between spermidine and eugenol and their induction of autophagy in cells.

The Eugedin Complex® production process is rather simple, straightforward and ultimately economical. It consists of five key stages:

1. The raw materials are wheat germ (purchased from Molino Naldoni) and clove essential oil (purchased from Xeda);
2. The wheat germ is processed: dried, pressed and ground into powder;
3. Eugenol is added and mixed with the wheat germ powder;
4. The powder now consisting of both spermidine and eugenol is dried;
5. The final powder mix is packaged in plastic bags or metal barrels and is ready to be sold as a raw material.