Omnia food supplement


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Potential advantages of Omnia v GcMAF

  1. Omnia® is a sulphate derivative, that contains no proteins and therefore is more stable in many ways. An example of this is that a sulphate is not affected by the stomach acid. Therefore it can be passed more easily through the gastrointestinal tract, which improves bioavailability and transportation.
  2. Due to the stability of Omnia®, it does not have any specific storage requirements. This therefore makes transportation and shipping much easier and effective.
  3. Research shows that the ingredients of Omnia® do not instigate allergic reactions.
  4. The ingredients of Omnia® are recognised as food supplements, and these have been used in different forms for decades. These include the three main ingredients of Chondroitin Sulphate, Vitamin D and Oleic Acid, which have been approved and recognised as dietary supplements in the U.S. by The Food and Drug Administration. 
  5. One of the key ingredients of Omnia® is Chondroitin Sulphate, which has been proven to be safe and effective within this formula by clinical trials.
  6. Omnia® is extremely bioavailable. The molecular structure of Chondroitin Sulphate has an essentially flexible ‘backbone’ , and therefore can easily accommodate the fatty acid that is Oleic Acid, which is also readily available. It can also accommodate the Vitamin D in this way.
  7. Due to the bioavailability of Omnia®, and the molecular structure and combination, it can be rapidly and easily absorbed via many routes. For example, orally, sub-lingually, topically etc. 
  8. Omnia® is nano-sized. This means that the molecular size is about 1,000 times narrower than that of a long protein such as GcMAF. This therefore means that  Omnia® is able to reach many more regions and targets in the body.
  9. Omnia® is manufactured in a state-of-the art ISO & GMP-certified facility in Europe.
  10. While GcMAF has one chemical bond for certain moieties, chondroitin has more than 50 moieties for N-Acetylgalctosamine (GalNac).  This alone boosts the immune stimulating properties of Omnia® over 50 times compared to GcMAF.

Omnia helps to maintain a healthy immune system.

Chondroitin sulphate is a component of Omnia. Chondroitin sulphate chains are thought to mediate many of the binding interactions between our immune cells and proteins [1].

Fig. 1.: Omnia consists of a large protein core, which is attached to glycosaminoglycan (GAG) chains. The GAG chains are made up of repeating chondroitin sulphate (CS) disaccharide subunits linked to form varying lengths [1]. 

Inflammatory responses, as a result of infection, require the migration of leukocytes from the vasculature to the infected area. Proteoglycans, including CSPGs, present on cell surface, facilitate leukocyte migration and modulate inflammation through the following mechanisms:

  • The direct activation of immune cells, such as T-cells, B-cells and monocytes via CD44 receptor; 
  • The direct activation of Toll-like receptors that recognize invariant structures (such as LPS) on pathogens. Recognition of these structures by TLRs results in the activation of the innate immune response;
  • Binding to inflammatory cytokines, chemokines and growth factors, which localises them to specific sites;
  • The ability to facilitate and promote leukocyte adhesion and migration;
  • Interactions between proteoglycans and matrix metalloproteinases, eg. proteoglycans conceal proteolytic cleavage sites protecting chemokines, cytokines, and growth factors from proteolysis.

In conclusion, proteoglycans provide precise control of tissue inflammation and immune response [1], [2], [3], [4].

Chondroitin sulphate as an immune modulator.

Too much activation of macrophages, accompanied by hyperproduction of inflammatory cytokines, induces damage in cells and causes inflammatory diseases. In this case, it is important to alleviate excess activation. 

Here, chondrotin sulphate may act as potent immuno-modulator. 

On the molecular level, one of the key players of inflammation process is NF-kB – protein complex, which controls gene transcription. Its activation, followed by nuclear translocation, results in binding to promoters of proinflammatory genes and production of proteins that contribute to tissue damage and to the inflammatory reaction. Chondroitin sulphate is able to diminish NF-kB activation and nuclear translocation, therefore acts as immune-modulator. 

This activity explains therapeutic effect of CS medical administration in multiple immune-mediated diseases, such as osteoarthritis, psoriasis, inflammatory bowel disease or atherosclerosis [5], [6]. 

1) Haylock-Jacobs S.: Chondroitin sulphate proteoglycans: Extracellular matrix proteins that regulate immunity of the central nervous system. Autoimmunity Reviews, 2011; 
2) Gill S. et al.: Proteoglycans: Key Regulators of Pulmonary Inflammation and the Innate Immune Response to Lung Infection. The Anatomical Record, 2010; 
3) Rachmilewitz J. Tykocinski M.: Differential Effects of Chondroitin Sulfates A and B on Monocyte and B-Cell Activation: Evidence for B-Cell Activation Via a CD44-Dependent Pathway. Blood, 1998; 
4) Zhang W.: Mechanistic insights into cellular immunity of chondroitin sulfate Aand its zwitterionic N-deacetylated derivatives. Carbohydrate Polymers, 2015; 
5) Souich P. et al.: Immunomodulatory and anti-inflammatory effects of chondroitin sulphate. Journal of Cellular and Molecular Medicine, 2009; 
6) Vallières M., Souich P.: Modulation of inflammation by chondroitin sulfate. Osteoarthritis and Cartilage, 2010.

Laboratory standards

Cyto Innovations Ltd works in accordance with ISO17025 and GMP European regulations, raw materials are registered and notified to the relevant authorities from where they are purchased.

Lectin activity assay

Biotinylated Vicia Villosa Lectin Assay. Samples are separated in 12% SDS PAGE and analyzed in WB using lectin specific for terminal GalNAc.  Batch should be declared a “PASS” if native blots are observed.

Cell based activity assay

Proliferation assay using RAW264.7 cells. When applied at a level of 40ng/mL to cells during a 72h incubation causes a retardation in cell proliferation when compared to cells that have had no additive or MAF added at the same concentration. The batch should be considered a “PASS” if the cell proliferation is <80% of the D-VDBP treated cells.

 

Sterility testing

Samples of each batch are sent for external sterility testing at a third party testing house. The test is a sterile filtration test which was validated for the procedure to meet the Ph. EU and USP In addition sample material is also incubated in TSB and Thioglycollate Broth between 20-35ºC for 14 days. The batch should be declared a “PASS” if there is complete absence of any bacterial growth in any of the broths or filter test.

Endotoxin detection

Samples of each batch are tested for the presence of endotoxin using a Charles River Endosafe PTS FDA approved endotoxin detection device.  The batch should be declared a “PASS” if there is <0.25 EU/mL. With a 0.25mL dose this is <0.0625EU/dose below the permissible limit of 5EU/Kg body weight.

PH level assessment

PH.Samples of each batch are assessed for pH with limits set between pH7.0-7.9. The batch should be declared a “PASS” if the measured pH is between pH7.0 and pH7.9.

Omnia Drops product specification (SP-002; 18.11.2016) compliance is confirmed by following analytical parameters 

ANALYTICAL PARAMETERS

PARAMETER METHOD REQUIREMENTS RESULT
FORMULATION AND CHARACTERISTICS Organoleptic Texture Liquid Pass
Colour White Pass
Odor Characteristic Pass
Taste Characteristic (oleic acid) Pass
CONCENTRATION Acc. to supplier’s COA Chondroitin sulphate 25 mg/ml ±10% Pass
Oleic acid 12.5 mg/ml ±10% Pass
ACTIVITY Acc. to supplier’s COA Vitamin D2 100 IU/ml ±10% Pass
Vitamin D3 100 IU/ml ±10% Pass
ENDOTOXIN LEVEL LAL assay 0.5 EU/ml   Pass
STERILITY Trypone Soya Agar Total aerobic microbial count <10 to the power of 3 cfu/ml Pass
Sabouraud (+ dextrose + chloramfenikol) Total combined yeast and mold count <10 to the power of 2 cfu/ml Pass
McConkey Broth Absence of E.coli in 10g Pass
MYCOPLASMA NAT/PCR Negative   Pass
RETROVIRUSES PERT Negative   Pass
pH Potentiometry 5.7 -6.0 (t=20°C)   Pass

Each 10ml Omnia dropper contains:

10ml sterile water.
250mg of chondroitin sulphate.
125mg of oleic acid.
10000 IU / 250ug vitamin D3.
1000 IU / 25ug vitamin D2.

There are approximately 150(no) drops in one 10ml Omnia dropper bottle.

Recommended daily dose

Orally - under the tongue:

Shake well before use. One drop to be taken sublingually once a day. Take one drop and keep in the mouth for at least 2 minutes to support absorption by the oral mucosa. Then swallow. The bioavailability of Omnia is increased by digestion. Do NOT drink (except water) or eat for at least 30 minutes after taking. Should not be used as a substitute for a varied diet. Do not exceed the daily dose. 

Orally - add to water:

Shake well before use. Add one drop to cool clean water and drink. The bioavailability of Omnia is increased by digestion. Do NOT drink (except water) or eat for at least 30 minutes after taking. Do not exceed the daily dose. Should not be used as a substitute for a varied diet.

Storage

For best results keep cool, avoid direct sunlight & use within 3 months of opening. Shake well before use to homogenise the emulsion (product separation is typical and no quality defect)