Rationale

One of the main components of healthy lifestyle of a modern person contributing to a long and active life, both physically and socially, is definitely healthy and balanced diet. What is meant is supplying the organism with adequate foodstuff for each particular individual which is balanced in terms of energy value, nutritious composition (fats, proteins and carbohydrates, macro- and microelements, vitamins and other biologically active substances) as well as the correct amount of food and its intake time. The norms of nutrition are defined in the Russian legislation as follows: ‘physiological norms of nutrition are scientifically grounded and approved by the federal medical executive authorities norms of foodstuff and energy intake, which fully satisfy the needs of a healthy person in the essential foodstuff and energy’ (The Law on Food Security in the Russian Federation). In the recent years various health improving food products have been gaining importance in the people’s nutrition, particularly biologically active supplements (BAS). Most of the BAS presented on the Russian market are certified by the producers as nutriceutics, which include vitamin and mineral complexes and articles of food (see the Table 1). The BAS are classified according to their main consumption instructions:

 

• compensating food deficiencies;
• maintaining organs and organism systems functions;
• reducing the risk of various diseases;
• maintaining microbiocenose in the bowels.

 

In fact the majority of BAS is positioned in the market as parapharmaceutics, i.e. substances having pharmacological effect. It is indeed true, as the BAS offered for sale in the market are mainly concentrated mineral, vitamin, amino acid, lipidic and other complexes which, as opposed to the vitamin enriched foodstuffs, have a strongly marked biological effect on the human organism. This is also confirmed by the results of the few clinical studies that have been conducted on the effects of BAS while treating various nosologies. It must be noted, that the amount and the quality of such research is growing continuously.

 

 

Table 1 

 

 

The above said gives reasons to consider prescribing the intake of the BAS as a serious responsibility of a qualified and knowledgeable doctor aware of biological mechanisms of certain ingredients functioning and their indications and contra-indications. This is valid even if the BAS are taken not regularly – as a prevention method or as a part of complex therapy of various diseases. The importance of taking nutriceutics for a modern person living in the urbanized society is conditioned, amongst other reasons, by anthropological and ecological influences of the environment. One of the most significant factors is the negative changes of internal organism environment, characterized by the accumulation of harmful substances, and at the same time, lack of the elements necessary for the organism maintenance. This phenomenon is very wide-spread among various layers of the population and has been continuing for several generations. The most harmful pollution factors are the results of anthropogenic chemical pollution – chemical and oil products, as well as other industrial products, heavy metals (mercury, lead, cadmium, etc.), radioactive waste, traffic exhaust fumes, air pollution of the cities, water and food contamination. The majority of the above pollutants are of hydrophobic nature, which means that they easily build into lipid and, in the first place, into biomembrane cell structure destroying the cell function. The biggest danger is presented by the substances of carcinogenic or potentially carcinogenic character (procarcinogens) – dioxides, organochlorine compounds, aflatoxins, nitrates. A big number of anthropogenic factors, in the first place chemical and radiation factors, initiate in the organism free radical and peroxide processes which not only directly pollute the internal environment, but also misconstrue the mechanisms of transferring the hereditary information and the metabolism. The BAS intake allows an easy and quick replenishment of the lacking foodstuffs, primarily micronutrients, and an increase of the organism spare capacities. Also it encourages the well-being of an actively growing organism and its separate systems (locomotorium, cardiovascular system, hormonal balance, etc.), as well as the immunity improvement and weight correction. The administration of the BAS is not a replacement of a traditional therapy approach to treatment of certain diseases, rather it is a natural addition to the modern methods and a kind of a bridge connecting the pharmacotherapy with the healthy lifestyle. The main proven and possible mechanisms of the BAS (nutriceutics) biological action:

•  Interosorbtion improvement 
•  Replenishment of the lacking micronutrients 
•  Increasing the mental and physical endurance 
•  Boosting the digesting abilities and regeneration of parietal mucous layer of the gastrointestinal tract (GIT)
•  Microcirculation improvement and antiinflammatory action on the GIT
• Antioxidant and antihypoxant action
• Normalizing of the general and local immunity (GIT, lungs, urogenital system)
• Dysbacteriosis elimination and normalizing the intestines microflora
• Efferential effect (aperient, diuretic, sudorific)
• Anticarcinogenic action

 

Nevertheless, the intake of BAS in pure form (tablets, capsules, solutions, powders, etc.) often causes negative feelings in a consumer, as in his/her perception it is associated with regular medicine administration. Therefore, as an alternative solution for such consumers one can recommend health improving food products, which are now introduced more and more widely in modern Russia. This puts the issue of creating easily digestible health improving foodstuffs on the first place of importance for the modern dietology and the food industry. This refers particularly to the microelements, since their bioavailability depends to a large extent on the type of products, its reduction range, the presence of other components and other factors, and can range between 1 and 30%. Absence of the requirement of foodstuff easy digestibility causes difficulty in dietary intake planning as well as in development of new foodstuffs. If an organism is not supplied with the necessary microelements, which are coenzymes of the many ferments and constitute other biologically active compounds and bioregulators, it may lead to slowing down of the vital processes and reactions accompanied by hypo- and dysfunction of the tissues and organs. Also the latter may lose their resistance to the harmful agents and demonstrate alterations characteristic of premature ageing.

 

Making up for the lacking microelements through the mere increase of their intake is limited by their low absorbability in the gastrointestinal tract, insufficient volume of the carriers in blood and cell membranes, as well as by the small volume of their depositing in the tissues. Limited absorption, transfer and transportation of microelements have apparent individual differentiations. In cases of excessive microelements intake the following may occur - function disorder of gastrointestinal tract, certain toxic effects and slowing down of functional activity. The above symptoms are connected with microelements being stored in places where their transfer and transportation are limited. The microelements excess does not only entail certain toxic effects, but also causes damage to cells, lumens and vascular walls, as well as to organs and tissues as a result of insoluble complexes built up in them.

 

Development of effective pharmacological agents assuring the replenishment of the lacking organism microelements is complicated by the problem of overcoming individual barriers which limit their uptake by the organism. Adjuvants administration leads to creating unstable compound complexes, the effect of which is usually connected with only one of the limiting chains of the uptake and metabolism kinetics. Chemical instability and limited storage period of such forms leads to less effective application and provides for the possibilities of toxic effects occurring when such complexes decompose.

 

Nowadays aquachelate complexes are indicated to be the most promising pharmacological forms. They allow replenishing the lack of biologically vital metals (for instance, Russian Federation patent #2115657), and also act as transportation system for effective transfer of metals, metalloids and various organic ligands through cell membranes. The aquachelate complexes structure allows to overcome the barriers set by the lack of natural microelements carriers in the organism and to deliver them to the target cells providing that the concentration is non-toxic for the other cells. Administration of aquachelate complexes as adjuvant form for microelements means lowering their single dose and course dose. This fact reduces the risk of gastrointestinal disorders, toxic effects and crystal deposition in the tissues. Easier microelements transfer to the target cells also allows to achieve a specific preventive effect without any side effects in other tissues.

 

What is more, it is a particularly important task to develop complex compounds which would combine aquachelate complexes with metalloids in organic form.

 

Goal

Researching biological effects of aquachelate complexes and developing biologically active supplements, food products and beverages containing such complexes and allowing to achieve the increase of the organs and tissues functional activity, higher organism resistance, activation of regeneration processes and prevention of premature ageing.

 

 

 

Tasks

 

• development and certification of the aquachelate complex as a food supplement of health improving action; 
• complex studying and assessment of aquachelate complexes biological effects, in particular, improving the cells, tissues, organs and systems functional activity; increasing the organism resistance to the harmful agents; activating the regeneration processes and early ageing prevention;
• researching daily and course dosages of aquachelate complexes that cause therapeutic, preventive and health improving effects;
• studying the food stuffs and beverages which can be enriched by aquachelate compleses and thereby not changing their main composition, organoleptic characteristics and nutrients biological availability;
• conducting research assessing the biological effects of the intake of aquachelate containing food stuffs and beverages.

 

 

Expected results

Biologically active supplements containing an aquachelate complex and certified for its consumption as a health improving means allowing to conduct studies of its biological effects and development of the products enriched by the aquachelate complexes.

Aquachelate complexes biological effects characterized by improved functional activity of organs, tissues and systems of the organism, better resistance to the harmful agents, activated regeneration processes and early ageing prevention.

Aquachelate complexes daily and course doses aimed at therapeutic, preventive and health improving effects.

Listing food products and beverages in which no changes of main composition, organoleptic characteristics and nutrients biological availability occur when aquachelate compexes are added.

Description of the biological effects after the intake of aquachelate containing food stuffs and beverages

 

 

Practical application

 

The results of the research will be used in the following innovative projects:

 

1)    Introduction into the medical practice and dietology of health improving products and biologically active supplements in the form of aquachelate complexes with accentuated biological effects:

 

• replenishment of lacking microelements in the organism;
•  increasing the functional activity of the organism systems;
• activating the tissue regeneration processes;
• improving the natural organism resistance to the harmful agents;
• prevention of early ageing processes.

 

2)    Developing the production technology of health improving products containing aquachelate complexes with accentuated biological effects.