Graminex G63™ Flower Pollen Extract for … · possible to reduce fat solubility and change the...

Graminex G63™ Flower Pollen Extract for Hepatotoxicity of the Liver

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Table of Contents

Hepatotoxicity 2 Causes of Hepatotoxicity 2 Alternative Medicine 2 Chemical Composition 3 Efficacy 3 Dosage 4 Conclusion 4 References 6 August 2015 Graminex LLC www.graminex.com

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Hepatotoxicity:

Hepatotoxicity is damage that occurs to the liver due to the toxic buildup of harmful elements in the body. This damage can cause normal liver functions to decrease or become ir-regular. The primary function of the liver is to act as a site for the transformation of foreign substances and toxic chemicals into less harmful compounds. This allows them to be easily eliminated from the body. Different metabolic proc-esses that complete these chemical transformations make it possible to reduce fat solubility and change the biological activity of toxic compounds. By converting toxins to inactive water soluble chemicals, the liver prevents them from being deposited and accumulated in the body’s fatty tissues. The neutralized water soluble chemicals can then be eliminated from the body via the urine or bile. The liver completes this process for both endogenous substances, which originate from within the body (e.g. cholesterol or proteins) and ex-ogenous substances, which originate from outside the body (e.g. chemicals or drugs). Because the liver is a major site for these transformations, it is extremely susceptible to drug induced injury, both from pharmaceuticals and over-the-counter (OTCs) medications.

Certain blood tests may be performed to determine if the liver is functioning properly. One of the most common is a blood test for billirubin. Billirubin is formed when the liver breaks down red blood cells prior to excretion in the bile. Elevated levels in the bloodstream indicate that the liver is not excreting bile normally. Blood tests may also be done to measure various enzymes that are known indicators for hepatotoxicity and liver damage. There are four common enzymes that when elevated indicate some sort of liver dam-age has occurred. These include alanine aminotransferase, asparatate aminotransferase, lactate dehydrogenase and alka-line phosphatase.1

Causes of Hepatotoxicity:

Common hepatotoxins that cause liver damage include alco-hols, OTC pain relievers, prescription medications, certain herbs and industrial chemicals. Among these hepatotoxins, drug induced liver damage accounts for 50% of all acute liver failures.2 Depending on the hepatotoxin, different forms of damage may occur including zonal necrosis, hepatitis, choles-tasis, granulomas and neoplasms. Based on the level of sever-ity in the different damage types and the magnitude of distur-bances on liver functions, large concentrations of hepatotox-ins ultimately cause acute liver failure. To clinically test for

liver damage, a number of biochemical markers are analyzed as indicators. These biochemical markers are able to quanti-tatively demonstrate a direct correlation with the amount of damage present in the liver.

G63™ Flower Pollen Extract Facts:

Non-solvent extracted 100% manufactured in USA

Standardized full spectrum formula Clinically supported for safety and efficacy

cGMP, Kosher, Pareve, Halal and Organic Processing Certified

Alternative Medicine:

Flower pollen extract is a standardized extract that has been used historically for over 50 years for various health indica-tions. The product is supported by a substantial amount of open, placebo-controlled and double-blind clinical trials. Flower pollen extract has been demonstrated to be effective, safe and without harmful side effects.

In these studies flower pollen extract is produced using a combination of unique growing and processing techniques. The raw pollen grains are harvested mechanically from the fields and are further processed to remove any plant mate-rial to isolate the pure pollen. Once in pure form, the pollen is extracted to remove the outer shell so the internal nutri-ents can be released. This extraction process is being done without the use of solvents by Graminex® in the United States. During extraction, the outer shells of the pollen grains along with the allergens are discarded, leaving only the internal nutrients behind. Throughout this process sub-stances that are toxic or harmful, like allergens and other

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high-molecular substances, are broken down and eliminated. The final product contains a synergistic formula of the natu-ral and complete nutrition factors that are necessary to gen-erate new life. This unique extract has been shown to help act as an effective liver protecting agent against external fac-tors, including various hepatotoxins that cause liver damage.

Chemical Composition of Flower Pollen Extract:

The pollen grains used to manufacture G63™ Flower Pollen Extract contain a complete profile of nutrients vital for hu-man health. Included in the chemical composition are a vari-ety of vitamins, cartenoids, minerals, amino acids, enzymes, lipids, fatty acids, prostaglandins, phytosterols, hydrocarbons and flavonoids. G63™ Flower Pollen Extract is a standard-ized product that meets the exact specifications for phytos-terol and amino acid content for every batch. It is manufac-tured using a combination of the water soluble, G60™ Flower Pollen Extract, and the lipid soluble, GFX™ Flower Pollen Extract, portions of the pollen grain. G60™ contains a standardized portion of amino acids and GFX™ contains a standardized portion of phytosterols. These two ingredients are blended into a 20:1 ratio to create a standardized, phar-maceutical grade powder. The unique chemical composition of the G63™ Flower Pollen Extract formula has been exten-sively studied for both safety and efficacy in the published literature. In addition to this G63™ Flower Pollen Extract has undergone complete toxicology studies.

Efficacy: There are several clinical studies that have demonstrated Flower pollen extract having beneficial effects in the event of contact with hepatotoxins. These studies have established the flower pollen extract’s ability to help protect from dam-age or reduce damage in the liver from exposure to paracetamol, allyl alcohol, ammonium fluoride, ethionine, carbon tetrachloride and galactosamine. In most of these studies the different hepatotoxins were administered to rats in conjunction with the flower pollen extract over a given period of time. Study designs examined both therapeutic and prophylactic applications of the flower pollen extract for effi-cacy. Different biochemical indicators were monitored and collected liver cell samples were examined to determine if the flower pollen extract treatment was effective in reducing overall liver damage. In a human trial, G63™ Flower Pollen Extract was administered without side effects in addition to each patient experiencing some form of improvement.3

Ammonium Fluoride

A common hepatotoxin standard that is used in clinical stud-ies for liver damage is ammonium fluoride. Ammonium fluo-ride is a compound that is used for etching glass, preserving wood and in printing and dying textiles. Prolonged exposure to this compound causes destruction of the liver’s functional units or lobules and an excessive accumulation of extracellu-lar matrix proteins, characterized as liver fibrosis. Two stud-ies have been completed demonstrating the benefits of flower pollen extracts on the liver after prolonged ammo-nium fluoride exposure. One of the studies conducted ap-plied the flower pollen extract simultaneously with the am-monium fluoride.4 This study found that when the flower pollen extract was administered at the same time as the in-toxication, damage to the liver practically did not occur. There was a substantial reduction in the negative activity of the toxin and it helped stop the development of negative changes within the liver tissue.

A second study with ammonium fluoride collected data on the biochemical indicators aminotransferase, alkaline phos-phatase, cholinesterase and bilirubin. It was demonstrated that under intoxication with ammonium fluoride alone, there was a rise in the activity of aminotransferases and alkaline phosphatase with a decrease in cholinesterase.5 There was also a rise in the bilirubin levels tested in the blood serum, providing evidence that there was liver damage occurring from exposure to ammonium fluoride. A prophylactic appli-cation of flower pollen extract after exposure was able to help normalize the enzymatic activity of the biochemical indi-cators and lower total bilirubin levels. This demonstrated flower pollen extract’s beneficial effect on the liver and its efficacy at normalizing liver functions post exposure.

Paracetamol

Another common hepatotoxin is paracetamol, or acetamino-phen, a commonly used OTC analgesic. In large doses paracetamol causes severe hepatic necrosis that leads to acute liver failure. Paracetamol toxicity far exceeds all other causes of acute liver failure in the United States.6 During the course of paracetamol intoxication biochemical indicators respond as previously mentioned with the addition of a marked decrease in glutathione. Glutathione is a natural anti-oxidant that is present in the liver. It plays a protective role in preventing liver damage from occurring. Levels of glu-tathione are often measured as an indicator for liver damage through a simple blood test.

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When flower pollen extract was administered therapeuti-cally the survival rate of the animals was increased, glu-tathione levels were increased and on physical examination, the hepatic lesions were decreased.7 The role of glutathione was found to be significant for the mechanism of action of the flower pollen extract in protecting the liver. An addi-tional study also indicated the normalization of biochemical indicators linked to necrotic changes that occur in hepatic cells.8 In reference to paracetamol toxicity, these studies clearly display the hepatoprotective effects of the flower pol-len extract.

Other hepatotoxins

Other studies that have been conducted using flower pollen extract for liver support have used allyl alcohol and galacto-samine. Study designs that looked at allyl alcohol intoxication involved the application of flower pollen extract after intoxi-cation as a therapeutic agent. Ongoing monitoring of the changes in biochemical markers was done to observe possi-ble therapeutic effects. Two studies showed flower pollen extract having a significant beneficial effect on the blood se-rum levels of biochemical indicators associated with allyl al-cohol intoxication including aminotransferase, alkaline phos-phatase, and bilirubin.9,10

Additional studies were conducted with galactosamine, a known hepatitis inducer, commonly used in liver damage research. In these studies flower pollen extracts helped bring about a rapid, significant reversion to normal or almost nor-mal aminotransferases and alkaline phosphatase activity as well as normal bilirubin levels.10,11 This indicates much of the damage caused by galactosamine in the liver was prevented. Various other studies have been completed showing flower pollen extract’s hepatoprotective effect on the liver under intoxications with different organic solvents and toxic com-pounds.12,13,14

G63™ Flower Pollen Extract Dosage

Flower pollen extract is supported by over 100 clinical stud-ies for various applications. These studies demonstrate the effectiveness of the product at varying dosages. Primary re-search as a pharmaceutical treatment has been conducted using a dose of 1500 mg/day. Independent clinicals con-ducted have used a range of 500-1500 mg/day. (Table 1)

Conclusion

Flower pollen extract has been used historically for a variety of health indications including liver support. The unique growing, manufacturing process and standardization methods used by Graminex provide a flower pollen extract raw ingre-dient that is superior to normal botanical extracts and bee pollen products on the market. Natural actives found in each batch of G63™ Flower Pollen Extract are the same each and every time it is manufactured to supply a pharmaceutical grade raw material.

There is evidence in all of these clinical studies that supports the use of flower pollen extract as a hepatoprotective sub-stance both therapeutically and prophylactically, especially when dealing with various intoxications with hepatotoxins. (Table 2) It has been demonstrated in primary and secondary literature that flower pollen extract can effectively help nor-malize biochemical indicators and enzymatic activity associ-ated with hepatotoxicity as well as help to reduce hepatic lesions and liver damage. As a natural botanical extract, G63™ Flower Pollen Extract may be used in combination with other substances known as liver protecting agents to help reduce the effects of hepatotoxins on the liver.14

In addition to these efficacy studies, Graminex has also con-ducted complete acute oral and acute dermal toxicity studies in addition to the LD50, to demonstrate that the product is nontoxic and considered safe. The addition of G63™ Flower Pollen Extract to a quality product formulated for liver sup-port will prove effective for both the manufacturers and end users. G63™ Flower Pollen Extract is available as a bulk powdered ingredient as well as in a variety of private labeled products.

G63™ G60™ GFX™

Pharmaceutical level dose

1500 mg/day 360 mg/day 18 mg/day

Average scientifically supported dose


Minimum scientifically supported dose


Table 1: Recommended daily dosages.

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Contact Graminex LLC to learn more about G63™ Flower Pollen Extract

for Hepatotoxicity of the Liver

Toll Free: 1-877-472-6469 Telephone: 1-419-278-1023 Email: [email protected]

Website: www.graminex.com

Manufacturing Facility: 2-300 County Road C

Deshler, Ohio 43516 USA

Corporate Office: 95 Midland Rd

Saginaw, Michigan 48638 USA

Summary of clinical study findings on hepatotoxicity with Flower Pollen Extract

Hepatotoxin Application Method

Results

Ammonium Fluoride

Prophylactic 1. Damage to the liver practically did not occur.4 2. Prevented negative liver changes from occurring.4 3. Normalized the disorder involving enzymatic and lipid parameters.5

Paracetamol Prophylactic Therapeutic

1. Increased the survival rate of animals.7 2. Decreased hepatic lesions. 7 3. Hepatoprotective effects displayed by normalization of biochemical

indicators associated with necrotic changes.8

Allyl Alcohol Therapeutic 1. Significantly reduced serum enzyme elevations induce by intoxication.9 2. Reduced damage to the liver.10 3. Normalized the activity of transaminase, phosphatase and bilirubin.10

Galactosamine Prophylactic Therapeutic

1. Prevented much of the damage actually caused by intoxication.10 2. Showed a rapid, significant reversion to normal or almost normal ami-

notransferase and alkaline phosphatase activity, as well as the bilirubin level.11

Ethionine Prophylactic 1. May be used for effective protection of liver cells from toxic actions.10

Carbon Tetrachloride

Therapeutic 1. Mitigated damage to the liver.10 2. Marked lowering of bilirubin levels in the blood serum and diminution

of liver weight.12

Organic Solvents Prophylactic 1. Normalized impairments affecting the enzymatic and lipid parame-

ters.13

Testosterone Therapeutic 1. Normalized biochemical indicators of necrotic changes, testifying to

the hepatoprotective effects on hepatic cells.14

Table 2: Summary of the clinical findings for Flower Pollen Extract with different hepatotoxins.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.


References: 1. Murali, A., Carey, W. Liver Test Interpretation-Approach to the Patient with Liver Disease: A Guide to Commonly Used Liver

Tests. Cleveland Clinic. April 2014. 2. Ostapowicz G, Fontana RJ, Schiødt FV, et al. Results of a Prospective Study of Acute Liver Failure at 17 Tertiary Care Cen-

ters in the United States. Ann. Intern. Med. 2002. 137(12):947–54. 3. Yokoyama, H., Suzuki, N., Nishimura, Y. Findings on Impairment of Hepatic Function through the Pollen Extract G63 of

Graminex Company. Kanda New Medical Clinic. 2006. 4. Humiczewska, M., Hermach, U., Put, A. The Effect of the Pollen Extracts Quercitin and Cernitin on the Liver, Lungs, and

Stomach of Rats Intoxicated with Ammonium Fluoride. Folia Biologica (Krakow). 1994. 42:157-166. 5. Mysliwiec, Z. Effect of Pollen Extracts (Cernitin Preparation) on Selected Biochemical Parameters of Liver in the Course of

Chronic Ammonium Fluoride Poisoning in Rats. Ann. Acad Med Stetin. 1993. 39:71-79. 6. Larson, A., Polson, J., et al. Acetaminophen-Induced Liver Failure: Results of a United States Multicenter, Prospective

Study. Hepatology. 2005. 42:1364-72. 7. Juzwiak, S. Experimental Evaluation of the Effect of Pollen Extract on the Course of Paracetamol Poisoning. Ann Acad Med

Stetin. 1993. 39:57-69. 8. Czarnecki, R., Librowski, T., Polanski, M. Hepatoprotective Effect of Flower Pollen Lipid Extract in Paracetamol-Induced

Hepatotoxicity in Mice. Folia Med Cracov. 1997, 38(3-4):53-61. 9. Wojcicki, J., Hinek, A., Samochowiec, L. The Protective Effect of Pollen Extracts Against Allyl Alcohol Damage of the Liver.

Arch Immunol Ther Exp. 1985. 33(6):841-9. 10. Samochowiec, L., Wojcicki, J. The Effect of Pollen on the Changes in the Liver of Laboratory Rats Evoked by Ethionine, Car-

bon Tetrachloride, Allyl Alcohol and Galactosamine. Arch Exp Veterinarmed. 1989. 43(4):521-32. 11. Wojcicki, J., Samochowiec, L., Hinek, A. The Effect of Cernitins on Galactosamine-Induced Hepatic Injury in Rat. Arch Immu-

nol Ther Exp. 1985. 33:361-370. 12. Wojcicki, J., Samochowiec, L. Effect of Cernitins on the Hepatotoxicity of Carbon Tetrachloride in Rats. Herba Polo-

nica.1984. 30:207-212. 13. Ceglecka M. Effect of Pollen Extract (Cernitin) on the Course of Poisoning with Organic Solvents. Ann Acad Med Stetin.

1992. 38:79-95. 14. Polanski M., Czarnecki R., Woroń J. The Hepatoprotective and Hyoplipidemic Effect of Flower Pollen Lipid Extract in Andro-

genized Rats. Folia Med Cracov. 1996. 37(1-2):89-95.

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