Dietary product effective to combat oxidative stress and...

Details Dietary product effective to combat oxidative stress and... Dietary product effective to combat oxidative stress and...

1999-07-30

2001-10-16

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

C424S439000, C424S450000, C424S464000

Reexamination Certificate

active

06303139

ABSTRACT:

The cell antioxidant pool is essentially made up of enzymatic antioxidants (Cu—Zn, superoxide dismutase—SOD, glutathione peroxidase-GSH-Px, catalase-CAT), of non-enzymatic lipophilic (RRR-&agr;-tocopherol-vitamin E and ubiquinol-CoQ
10
H
2
—) and hydrophilic (glutathione-GSH, urates, albumin) antioxidants and of protic transition metal ion sequestrating agents (ferrite, transferring, ceruloplasmin) see bibliographic references 1-7).
Each molecule has a specific biological function: for example the vitamin E and the ubiquinol are concentrated in the cell and sub-cell membranes with the main role of inhibiting lipo-peroxidation induced by oxygen reactive species (ROS) and other radicals on the unsaturated structures of the membranes, in particular the polyunsaturated fatty acids (PUFA) ; SOD, GSG-Px and CAT are responsible for removal of O
2
and H
2
O
2
, respectively.
Human cells have an antioxidant pool sufficient to counteract the normal physiological production of oxygen reactive species (ROS) and other free radicals; however the naturally present antioxidant pool is not capable of counteracting an increase in generation of ROS; in these cases, so-called “oxidative stress” occurs (see bibliographic reference 2).
From the above it can be seen that the insurgence of “oxidative stress” can be caused by two phenomena: the first is the lack of antioxidant molecules, and the second is the uncontrolled increase of oxygen reactive species (ROS) and free radicals, which are able to cause irreversible oxidation not only of the polyunsaturated fatty acids (PUFA), but also of proteins, nucleic acids and sugars. Oxidative stress is present to a varied extent in a number of serious diseases in man: while this does not mean that oxidative stress is the cause of these diseases, it does testify, as confirmed by a number of studies, that oxidative stress can have a negative influence on the progress of said diseases, causing further damage to the cells of an organism that is already sick (see bibliography and references 1 and 2).
It has now surprisingly been found that a dietary product comprising ubiquinone (CoQ
10
), stabilized vitamin E, phospholipids, selenium of organic origin and L-methionine, by acting both on the call wall reconstitution mechanisms, and consequently on that of the phospholipids forming it, and on the reintegration of glutathione and glutathione peroxidase, helps to combat cellular oxidative stress in an effective manner.
Oxidative stress appears significantly involved in certain diseases with a serious social impact, such as AIDS, seborrheic dermatitis, atopic dermatitis, leprosy, multiple sclerosis, in which genetic factors, malnutrition and/or under-nourishment, an incongruous lifestyle, the use of drugs and toxic substances, have an important etiologic role. It has been found that in the blood of patients suffering from these diseases, the significant deficiency of ubiquinole-ubiquinone, vitamin E, glutathione and glutathione peroxidase (GSH and GSH-Px), which is more or less marked according to contingent conditions, is associated with a deficiency of polyunsaturated fatty acids (PUFA) in the phospholipids (see references 8-12). According to the state of the art, administration of the molecules identified above to patients suffering from seborrheic and atopic dermatitis is simply and generally described, although said administration takes place in a separate and non-homogeneous manner, and this type of administration has actually shown extremely promising results (see references 11-12).
SUMMARY OF THE INVENTION
An object of the present invention is therefore a composition comprising:
Ubiquinone
 5-8%
Stabilized vitamin E
12-15%
Polyunsaturated phospholipids
45-52%
Organic selenium
 2-5%
(corresponding to 0.1-3%
ionic selenium)
L-methionine
23-32%
along with the usual tolerated vehicles.
A further object of the present invention is a composition for a dietary product comprising:
Ubiquinone
 5-8%
Stabilized vitamin E
12-15%
Polyunsaturated phospholipids
45-52%
Organic selenium
 2-5%
(corresponding to 0.1-3%
ionic selenium)
L-methionine
23-32%
along with the usual pharmaceutically tolerated vehicles.
The percentages indicated are expressed as a percentage by weight with reference only to the total weight of the active ingredients in the composition of the dietary product.
A further object of the present invention is the use of the composition for preparation of a dietary product that is effective in combating oxidative stress and cell decay.
A further object of the present invention is the use of the composition indicated above to produce a dietary product effective as a coadjutant in the treatment of mechanisms of mutagenesis and carcinogenesis, of immune-deficiency mechanisms, or other alterations of the immune system, of diseases of myelinic origin or other pathologies deriving from a progressive alteration in the neurotransmission mechanisms, of skin diseases and of cardio-vascular diseases.
A further object of the present invention is the use of the composition mentioned above to prepare a dietary product in the treatment of infectious diseases of viral or bacterial origin, and those deriving from other external pathogens, of tuberculosis, of leprosy, of herpes simplex labialis or genitalia, of AIDS, of multiple sclerosis, or atopic dermatitis, of vitiligo, in vaccination against allergies or other alterations of the immune system, of diseases of myelinic origin or other pathologies deriving from a progressive alteration in the neurotransmission mechanisms.
The present description comprises fifteen figures which show, in graph form, the influence of administration of a composition according to the present invention to the patients who will be more clearly specified in example 3 in case of
FIGS. 1
to
9
and in example 4 in case of
FIGS. 10
to
15
:
FIG. 1
shows the vitamin E concentration in the blood plasma versus time:
FIG. 2
shows the blood plasma concentration of oxidized and reduced ubiquinone (total ubiquinone) versus time;
FIG. 3
shows the concentration of vitamin E (expressed as micrograms of vitamin E in the lymphocytes per ml of blood) in the lymphocytes versus time;
FIG. 4
shows the reduced glutathione concentration in the erythrocytes versus time;
FIG. 5
shows the glutathione peroxidase concentration in the erythrocytes versus time;
FIG. 6
shows the trend of the palmitic acid concentration in the plasma versus time;
FIG. 7
shows the trend of the diomo-&ggr;-linolenic acid concentration in the plasma versus time;
FIG. 8
shows the trend of the arachidonic acid concentration in the plasma versus time;
FIG. 9
shows the trend of the docosahexanoic acid concentration in the plasma versus time;
FIG. 10
shows the vitamin E concentration in the blood plasma versus time in a different population of patients form those referred to in
FIG. 1
to
9
;
FIG. 11
shows the blood plasma concentration of total ubiquinone versus time;
FIG. 12
shows the concentration of vitamin E in the lymphocytes versus time;
FIG. 13
shows the reduced glutathione concentration in the erythrocytes versus time;
FIG. 14
shows the glutathione peroxidase concentration in the erythrocytes versus time; and
FIG. 15
shows the arachidonic acid concentration in plasma.


REFERENCES:
patent: 0519876 (1992-12-01), None
patent: WO 96/17626 (1992-12-01), None

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