Assimilation of inorganic selenium and organic germanium by...

Details Assimilation of inorganic selenium and organic germanium by... Assimilation of inorganic selenium and organic germanium by...

1999-04-23

2002-04-09

Hendricks, Keith (Department: 1761)

Food or edible material: processes, compositions, and products

Dormant ferment containing product, or live microorganism...

Yeast containing

C435S255200, C435S255210

Reexamination Certificate

active

06368643

ABSTRACT:

FIELD OF INVENTION
The present invention relates generally to the field of human therapeutic products, human dietary supplements, and methods for their manufacture. More specifically, the invention relates to specially formulated yeast compositions containing substantial amounts of intracellular selenium and germanium.
BACKGROUND OF THE INVENTION
Metal supplementation of the human diet is generally recognized as an important area in the field of nutritional science. Although no “RDA” minimum daily intake requirements have been officially adopted for many such compounds, research has strongly suggested that absence of some minerals, particularly metallic minerals such as selenium and germanium, can lead to improper functioning of the body's metabolic processes, and to various diseases and disorders. For example, selenium has a preventative role in the etiology of cancer and may work as a therapeutic agent against numerous tumors. [Milner and Hsu,
Inhibitory Effects of Selenium on the Growth of L
1210
Leukemic Cells
, Cancer Research, May 1989, 41(5):1652-6; Goodwin et. al.,
Selenium and Glutathione Peroxidase Levels in Patients with Epidermoid Carcinoma of the Oral Cavity and Oropharynx
, Cancer, Jan. 1, 1983, 51(1):110-5]. Similarly, a specific compound of germanium, carboxyethylgermanium sesquioxide, has been used as a dietary supplement for treatment of hypertension. [See, Asai, U.S. Pat. No. 3,793,455].
Nutritional supplementation of the human diet with metals, using inorganic or organometallic sources for the metals, has met with limited success. Safety and efficacy in the human metabolism of such metals has been questioned, since most inorganic forms of metals are known to have appreciable toxicity. For example, selenium is usually administered as selenium trioxide species—an agent which is extremely toxic. Similarly, inorganic germanium compounds, such as germanium dioxide and metallic germanium, are known to have inherent toxicity. In addition, inorganic forms of such metals generally have a low bioavailability, making their use in nutritional supplements questionable.
Supplementation of the human diet with metal-enriched yeast products has been sought as an improved methodology for bioavailability and law toxicity. Potential advantages of administering a metal derived from yeast as a nutritional supplement over non-yeast derived forms are that the toxicity of the metal will be lower in yeast derived organometallic compounds, and that since yeast-derived organometallic compounds are more soluble, such compounds will be better metabolized by the human body.
For example, selenium metal, usually highly toxic when administered in inorganic form such as SeO
3
Na
2
, has been shown to be more effective nutritionally when ingested as a yeast-derived substance. [See, e.g., Baerwald,
Gordian
, 94 (11):169-173 (1994)]. A method of producing selenium-enriched food yeast such as
Saccharomyces Cerevisiae
or
Candida Utilis
has been reported. When dried and fed to rats, these selenium-enriched yeast effectively prevent hepatic liver necrosis. [Reed et. al.,
Yeast Tech
., AVI Publ. Co., Conn. (1973)]. Unfortunately, this method results in the production of yeast having low selenium content as well as a relatively high extracellular concentration of inorganic selenium. U.S. Pat. No. 4,530,846 describes a method for producing a selenium-enriched yeast that yields yeast with a moderate intracellular selenium content of about 1,000 ppm. The yeast produced by this method is cultivated using a procedure that involves incremental feeding of the yeast culture. Improved methods of manufacture and special yeast stains can yield higher intracellular Selenium metal concentrations and reduced toxicity. See PCT 98/37172.
Generally, high extracellular concentrations of selenium are to be avoided, while higher intracellular concentrations are preferred because this indicates an increased relative concentration of selenium in the organic form which, as noted above, has been noted to be preferred for administrations to humans. For this reason, prior efforts at producing selenium-based yeast products have focused on the ability to provide increased intracellular concentrations of selenium. For example, U.S. Pat. No. 4,530,846 ('846) describes a method for producing a selenium-enriched yeast that yields yeast with a moderate intracellular selenium content of about 1,000 ppm. The yeast produced by this method are cultivated using a procedure that involves incremental feeding of the yeast culture. The '846 patent states: “While intracellular selenium contents of yeasts are preferably in a range of 1,000 ppm or more, preferably as high as 2,500 ppm, the process has, as its practical limitations, the capacity of the yeast to assimilate the selenium during the yeast growth cycle without adverse effects on yield due to the selenium additive to the nutrients”. In addition to the recognized limitations on the ability to achieve higher concentrations of intracellular selenium, and prior art also demonstrates that yeast-derived selenium products still exhibit substantial toxicity. For example, the LD
50
the yeast product described in the '846 patent is reported to be the 7 mg per kilogram. In practice, the LD
50
rating for a product limits the amount that may be administered to a human as part of a nutritional program or as part of an overall therapy to treat a disease.
A method for preparing germanium-derived yeast has been taught by Komatsu, JP 77-46138770420. However, this method involves the preparation of germanium yeast using a highly toxic form of germanium, GeO
2
, as the source of germanium for the feed and cultivation of the yeast. The major shortcoming of the method of Komatsu is that the yeast produced by the method has an appreciable content of highly toxic non-metabolizable germanium, and is therefore not useful as a human dietary supplement. In contrast to such inorganic forms of germanium, organic germanium compounds such as carboxyethylgermanium sesquioxide is non-toxic to the human body, having LD50 values in excess of 5 g/kg. Carboxyethylgermanium sesquioxide has been used to prepare a germanium-derived yeast. [See U.S. application Ser. No. 08/661,089, now U.S. Pat. No. 6.017,526].
Although yeast has been used to assimilate metals, beneficial combinations of metals derived from yeast are needed as are methods to produce such compositions, specifically selenium-germanium enriched yeast where: (1) the yeast product contains high intracellular selenium and germanium content; (2) the yeast product is substantially non-toxic to the human body at concentrations suitable for dietary supplementation or therapy; and (3) the chemical form of selenium and germanium produced by the selenium-germanium enriched yeast is highly metabolizable by the human body, and thus a useful and significantly improved agent for the nutritional supplementation of the human diet or for administration as a therapeutic agent, alone or in combination with other agents, in the treatment of disease.
SUMMARY OF THE INVENTION
The present invention overcomes the shortcomings of the prior art by providing a method for producing a selenium-germanium enriched yeast product that has a high intracellular content of organically bound trivalent selenium and germanium in high biological activity in a non-toxic form, providing a nutritional supplement which incorporates the selenium-germanium enriched yeast to promote good nutrition, and providing a therapeutic agent that can be administered for the treatment of disease. The present invention also includes the novel germanium and selenium-containing yeast, and the selenium-germanium yeast product in a form suitable for administration.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention relates to methods of cultivating yeast using selenium and germanium compounds resulting in a dried selenium-germanium enriched yeast product with high biological activity, nutritional supplements comprising thi

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