AU2001273364A2 - Mediating the effects of alcohol consumption by orally administering active dry yeast - Google Patents

Description

WO 03/006642 PCT/US01/21870 1 MEDIATING THE EFFECTS OF ALCOHOL CONSUMPTION BY ORALLY 2 ADMINISTERING ACTIVE DRY YEAST 3 4 The present invention relates to a process for lowering of blood alcohol (i.e.

ethyl alcohol) levels in humans after they imbibe alcoholic beverages such as beer, 6 wine or distilled spirits.

7 Consumption of alcoholic beverages in moderate amounts is an accepted 8 societal practice. Additionally, consumption of alcoholic beverages in moderate 9 amounts is considered to provide some health benefits in terms of reduced stress and incidence of heart attack. Consumption of alcoholic beverages in moderate 11 amounts also is considered by many people to enhance the flavor and enjoyment of 12 food. However, even moderate social drinkers can be affected by alcohol. Ethyl 13 alcohol (CH3CH 2 OH) is a major purpose for the consumption of alcoholic beverages.

14 When such beverages are consumed, the alcohol enters the stomach and is soon transported to the small intestine. From here the alcohol enters the blood stream via 16 the portal vein and goes to the liver. Here, a portion of the alcohol is oxidized to 17 acetaldehyde by the enzyme alcohol dehydrogenase. The unoxidized alcohol goes 18 to every part of the body through the general circulation. This alcohol, which has 19 free access to every cell in the body, exerts an influence on the central nervous system and the brain. These effects are well known. Operation of a motor vehicle is 21 considered illegal if the level of alcohol in the blood (blood alcohol level) is above 22 0.1% (in some states) or 0.08% (in other states). Because alcohol diffuses into every 23 cell in the body freely, the blood alcohol level may be measured in the breath as well 24 as in the blood. The acetaldehyde produced is further oxidized almost instantaneously to acetate which enters the pathways of general metabolism.

26 Acetaldehyde and acetate have no effect on the nervous system or the brain.

27 Continued circulation through the liver eventually removes all the alcohol.

28 The enzyme alcohol dehydrogenase requires a coenzyme called nicotinamide 29 adenine dinucleotide (NAD) in order to catalyze the conversion of ethanol to acetaldehyde. The first step in the metabolism of ethanol can be shown by the following equation:

NAD

CH

3

CH

2 0H alcohol dehydrogenase

CH

3 CHO NADH 2 (1) U. S. Patent 4,450, 153 to Hopkins proposes a process for reducing the effects of alcohol consumption by reducing the alcohol content in human blood by the administration of alcohol oxidase. According to Hopkins, alcohol oxidase may be administered by direct injection into the human body, or by direct contact with the blood by means of dialysis. Hopkins also suggests that alcohol oxidase may be administered orally; however, Hopkins needs his alcohol oxidase to be enteric coated to protect it from being destroyed in the stomach. He does not reduce alcohol levels in the stomach. He actively avoids this.

It would therefore be advantageous if a process for the reduction of human blood alcohol level by attacking alcohol only in the stomach could be devised.

In accordance with the present invention, blood alcohol level is lowered bythe oral administration of an extraneous source of the enzyme alcohol dehydrogenase before or concomitantly with the drinking of the alcoholic beverage.

The alcohol dehydrogenase may be consumed as the purified enzyme, or more conveniently, by the ingestion of a natural source of the enzyme, such as active dry bakers, brewers, vintners or distillers yeast. As used herein, active bakers, vintners and distillers yeast comprise Saccharomyces cerevisiae, and active brewers yeast comprises Saccharomyces uvarum. These yeasts all contain alcohol dehydrogenase andmcotinamide adenine dinucleotide (NAD). These yeasts may be delivered in powdered, paste or liquid form, i. e. suspended in a liquid, but most conveniently are packaged in dose or portion controlled dried form as a tablet or-caplet, or in capsule form.

WO 03/006642 PCTIUS01/21870 1 It has been found that ingesting active dry bakers yeast (the yeast most 2 readily available commercially) or brewers, vintners or distillers yeast, just before, or 3 during, the drinking of an alcoholic beverage, oxidizes a portion of the alcohol while 4 still in the stomach, which results in a lower peak blood alcohol level, and also a lesser area under the curve of a plot of blood alcohol level vs. time. The action of the 6 alcohol dehydrogenase on the alcohol is only in the stomach, so the alcohol 7 dehydrogenase source must be ingested while the alcoholic beverage is still in the 8 stomach. It will have no effect once the alcohol has left the stomach and entered the 9 bloodstream, because the enzyme is destroyed by the acidity and proteolytic action in the stomach.

11 Other features and advantages of the present invention will be seen from the 12 following detailed description, taken in conjunction with the accompanying 13 drawings, wherein: 14 Figs. 1-8 are plots showing reduction of blood alcohol levels over time with several alcoholic beverages, with and without the ingestion of alcohol 16 dehydrogenase from active dry yeast.

17 As noted supra, when an alcoholic beverage is consumed, the alcohol enters 18 the stomach and is soon transported to the small intestine. The speed of egress from 19 the stomach is delayed by the presence of food or fats in the stomach, and by the dilution and buffering capacity of the alcoholic liquid. The speed of the egress from 21 the stomach is quickened by high concentration of the alcoholic drink and by carbon 22 dioxide in the drink. In the small intestine, the alcohol is absorbed into the blood 23 stream via the portal vein and goes to the liver. In accordance with the present 24 invention, a portion of the alcohol while still in the stomach is oxidized to acetaldehyde by the ingestion of an extraneous source of the enzyme alcohol 26 dehydrogenase.

27 Ingestion of the enzyme alcohol dehydrogenase in accordance with the 28 present invention may be before or concomitantly with the consumption of the 29 alcoholic beverage. Continued drinking requires the periodic ingestion of additional alcohol dehydrogenase during the drinking period. The amount of alcohol WO 03/006642 PCT/US01/21870 1 dehydrogenase which should be ingested to reduce the blood alcohol level to an 2 acceptable level depends on several factors: 3 the weight of the individual; 4 the sex of the individual; the amount of alcohol consumed; 6 the rate of alcohol consumption; 7 the general health and age of the individual; and 8 the presence of food in the stomach.

9 Generally, the alcohol dehydrogenase is ingested in the amount of 0.5 to grams of active dry bakers, brewers, distillers.or vintners yeast. The amount needed 11 is determined by the six factors listed above, and the idiosyncratic behavior of 12 different people to alcohol. While the alcohol dehydrogenase may be ingested, for 13 example, as a suspension in a liquid or paste, the most convenient and effective way 14 to administer the alcohol dehydrogenase is by means of dose controlled tablets, capsules or caplets containing active dry bakers, brewers, vintners or distillers yeast.

16 The advantage of ingesting the alcohol dehydrogenase in this manner is that it 17 permits the drinker to self-dose during the imbibition period. Since the ingested 18 alcohol dehydrogenase does not long survive in the acidity of and in the presence of 19 the proteolytic enzymes in the stomach, the ingested alcohol dehydrogenase has no effect beyond the stomach.

21 A further understanding of the invention will be seen from the following 22 working Examples, in which blood alcohol content was measured using an Alco- 23 Sensor III blood alcohol content breath analyzer, available from Intoximeters, Inc., St.

24 Louis, MO. The alcohol dehydrogenase was administered as active dry bakers yeast available from Fleischmann's Yeast Division of Burns Philp Food, Inc., Fenton, MO., 26 Red Star Yeast from Universal Foods, Milwaukee, WI and a wine yeast from 27 Lallemand, Montreal, Canada.

28 Example I 29 Eighty-eight milliliters of 80 proof vodka, diluted with 80 ml. of water are consumed by a young, 160 pound (72.6 kg.) adult woman, within 5 minutes. The WO 03/006642 PCT/US01/21870 1 alcohol content in the breath, directly proportional to the blood alcohol level, is 2 measured periodically until the level falls below 0.002%.

3 The experiment is repeated, with the same woman, but this time, 2.5 g. of 4 active dry bakers yeast is ingested followed by 88 ml. of 80 proof vodka diluted with 80 ml of water. The alcohol content in the breath is measured periodically.

6 The results for both tests are shown in Fig. I and show the decrease in blood 7 alcohol level caused by the yeast. The decrease, as measured by the areas under the 8 curves in blood alcohol level min. was 29%.

9 Example II The same tests, without and with the ingestion of 2.5 g. of active dry bakers 11 yeast were done. This time the tests were run with a young, 155 pound (70.3 kg.) 12 adult man.

13 The results for both tests are shown in Fig. 2. The decrease in blood alcohol 14 level when the yeast was taken is clearly shown, and quantitatively demonstrated by the reduction in blood alcohol level-min. of 23 in the areas under the curves.

16 Example III 17 A mature 170 pound (77.1 kg.) adult man consumed 268 ml. of chardonnay 18 wine, 13% alcohol by volume in 11 minutes. His blood alcohol level was measured 19 periodically.

The test was repeated, by the same man, but this time 2.5 g. of active dry 21 vintners yeast was ingested just before the wine was consumed. The blood alcohol 22 level was measured periodically.

23 The results are shown in Fig. 3. The ingestion of the yeast lowered the peak 24 level and decreased the area under the curve, in blood alcohol level-min. by 36%.

Example IV 26 A mature, 170 pound (77.1 kg.) woman performed the same tests as in 27 Example III.

28 The results are plotted in Fig. 4. The areas under the curve, in blood alcohol 29 level-min., decreased by 21% when the yeast was taken just before the wine was consumed.

WO 03/006642 PCT/US01/21870 1 Example V 2 Seven hundred and ten ml. (24 oz.) of a standard American beer alcohol 3 by volume) was consumed by a mature, 150 pound (68 kg.) adult woman in 13 4 minutes, and then the blood alcohol level was measured periodically.

The same woman ate 5.0 g. of active dry bakers yeast and then drank the 6 same volume of the same beer. The blood alcohol was measured periodically.

7 The results are shown in Fig. 5. The yeast reduced the area under the curve, 8 in blood alcohol level-min., by 26%.

9 Example VI Twenty-four ounces of a standard American beer, the same as in Example V, 11 was consumed by a mature, 140 pound (63.4 kg.) adult man in 8 minutes. His blood 12 alcohol level was measured periodically.

13 The same amount of the same beer was consumed by the same man, except 14 2.5 g. of active dry bakers yeast was taken at the start of the beer drinking, which was finished in 14 minutes. Blood alcohol levels were measured periodically.

16 The results of both tests are shown in Fig. 6. The area under the curve, in 17 blood alcohol level-min., was reduced by 30% by the yeast.

18 Example VII 19 Twenty-four ounces of a light beer, alcohol content 4.2% by volume, was consumed by a mature, 150 pound (68 kg.) adult woman, after 3.0 g. of active dry 21 brewers yeast was ingested, all in 15 min. The blood alcohol level was measured 22 periodically.

23 The same amount of the same beer was consumed by the same woman, but 24 without any yeast.

The results of both tests, are shown in Fig. 7. The area under the curve, in 26 blood alcohol level-min. was reduced by 38% by the yeast.

27 Example VIII 28 A mature, 155 pound (70.3 kg.) adult man consumed 24 oz. of the same beer 29 as in Example VII, right with the ingestion of 1.5 g. of active dry bakers yeast. His blood alcohol level was measured periodically.

The above test was repeated, but without ingestion of any yeast.

The results are shown in Fig. 8. The area under the curve, in blood alcohol level-min, was reduced by 38% when yeast was taken.

Various changes may be made in the foregoing invention without departing from the spirit and scope thereof.

In the specification and claims the term "comprising" shall be understood to have a broad meaning similar to the term "including" and will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. This definition also applies to variations on the term "comprising" such as "comprise" and "comprises".

Claims (12)

1. A method of mediating the effect of alcohol consumption by a person which comprises orally administering active dry yeast containing alcohol dehydrogenase to said person prior to or simultaneously with consumption of an alcohol-containing beverage, whereby to oxidize a portion of the alcohol while still in the stomach of said person.

2. A method according to claim 1, wherein said active dry yeast is administered in a dose of from 0.5 to 10 grams.

3. A method according to claim I or claim 2, wherein said active dry yeast is selected from active yeast, active dry brewers yeast, active dry vintners yeast, and active dry distillers yeast.

4. A method according to any of claims 1-3, wherein said active dry yeast is administered in tablet, caplet or capsule form.

A method according to any of claims 1-3, wherein said active dry yeast'is consumed as a powder, paste or liqiid.

6. A composition when used to mediate the effect of alcohol consumption by a person, said compositin comprising active dry yeast containing alcohol dehydrogenase in an ingestible carrier to be consumed by said person prior to or simultaneously with consumption of an alcohol-containing beverage, said dehydrogenase serving to oxidize a portion of the alcohol while still in the stomach of said person.

7. A composition according to claim 6, wherein said active dry yeast is in a carrier dose of from 0.5 to 10 grams.

8. A composition according to claim 5 or 6, wherein said active dry yeast is selected from active yeast, active dry brewers yeast, active dry vintners yeast, and active dry distillers yeast.

9. A composition according to any of claims 5-8, wherein said active dry yeast is administered in tablet, caplet or capsule form.

A composition according to any of claims 5-8, wherein said active dry yeast is consumed as a powder, paste or liquid.

11. A method of mediating the effect of alcohol consumption by a person substantially as herein described with reference to the examples.

12. A composition for mediating the effect of alcohol consumption substantially as herein described with reference to the examples. DATED THIS NINTH DAY OF JANUARY 2004 OWADES, JOSEPH L. BY PIZZEYS PATENT AND TRADE MARK ATTORNEYS