Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-01-14
2004-03-09
Barts, Samuel (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S053000, C536S001110, C544S062000, C544S032000, C544S034000, C544S114000, C544S276000, C546S044000, C540S495000, C549S006000
Reexamination Certificate
active
06703371
ABSTRACT:
The present invention relates to the novel use of certain compounds, in particular active pharmaceutical ingredients, for the manufacture of products with oxygen-sparing action during physical work, and to novel preparations with this action.
It is known that muscle glycogen is dependent on the diet and that only certain dietary constituents are suitable for its synthesis and are effective in varying degree. As a prerequisite for their efficacy it is necessary during their metabolic conversion for glucose or glucogenic metabolites to be formed. Efficacy is restricted de facto to carbohydrates and proteins, a further necessary prerequisite being that they are rapidly broken down into their constituents in the elementary tract and, during this, glucose and glucogenic amino acids are liberated and are able to have a beneficial effect on muscular glycogen synthesis.
In addition to glycogen, fats are available to the muscle and can be utilized alone or together with the glycogen. Glycogen and fats differ, however, in that glycogen contrasts with fats in that it requires no oxygen for energy production because the formation of glucose from glycogen is subject to an anaerobic metabolic sequence during which fatty acids liberated from fats undergo aerobic utilization.
The work capacity during physical activity, especially sustained work, is limited by the individual oxygen uptake capacity and the maximum individual heart rate. However, only part of the oxygen uptake is used for mechanical work, whereas a larger proportion serves to produce heat. The efficiency of mechanical work may vary within wide limits but averages only about 20%.
Active ingredients which reduce the oxygen demand for the same mechanical exertions increase the work capacity. Breakdown of the glycogen stored in muscle makes an increase in work capacity possible in the natural way in this sense. After the breakdown has taken place, the glycogen is formed anew during the resting period, provided that suitable nutrients such as easily digestible carbohydrates or meat from young animals and fish are consumed. On the other hand, nutrients administered shortly before or during the physical work have no effect on oxygen consumption or have an adverse effect inasmuch as they increase the oxygen demand for the same work. These interactions are attributable to additional oxygen demand caused by digestion, absorption and anabolism.
Besides these known associations, it has been found, surprisingly, that the oxygen consumption induced by mechanical work is also influenced by changes in the atmospheric pressure. It has been found in this connection that a fall in pressure of 1 mbar on average increases the oxygen demand by about 4%, which means that the work capacity may be considerably reduced under the influence of a low-pressure zone. No explanation for this effect is known. However, it is to be assumed that a change in the carbon dioxide content in the blood might be responsible for the changes in the oxygen demand because it is known that the alveolar carbon dioxide concentration rises when the atmospheric pressure falls.
Table 1a shows the results obtained in the period from Feb. 13 to Mar. 6, 1999, with a male subject in good physical condition under standard conditions. The subject was required each morning in the fasting state to perform successively (without interruption) at mechanical power output of 100 W, 125 W and 150 W, each lasting 10 minutes (total test duration 30 minutes each time). A bicycle ergometer from Ergo Fit (Pirmasens, Germany) was used for this, and the required work was controlled at 60 pedal revolutions per minute in each case (controlled by a metronome from Seiko, Japan) by means of an eddy current brake. A heart rate computer from Polar Electro (Kempele, Finland) was used for continuous measurement of the heart rate; the atmospheric pressure was measured by an electronic barograph from Altitude Instrumentation (Paris, France) with a resolution of 0.1 mbar; the temperature and relative humidity were measured by an electronic thermohygrometer. The heat production induced by mechanical exertion was calculated from the changes in the heart rate. An alternative possibility is also to determine it on the basis of the increase in humidity caused by the perspiration (the tests are carried out in a closed room) or reduction in weight (1 g of water=2.26 kJ). The subject received a high-carbohydrate diet mainly composed of pasta together with meat from young animals (veal, chicken, fish), in order to ensure an adequate supply of protein, throughout the three-week duration of the test. The values indicated in table la for the “average heart rate” are in each case averages over the 30-minute duration of the test; relative values for the oxygen consumption were established on the basis of the heart rates in a known manner, and the relative values indicated in Table 1a are based on the oxygen consumption on the first day (=100%); the values listed in the column “heat production” in Table 1a give the percentage deviation of the heat production, established on the basis of the perspiration, from the average from all the tests.
TABLE 1a
Effect of changes in the atmospheric pressure
on the oxygen consumption induced by physical work
Atmospheric
Average
Relative
Heat
Date
pressure
heart rate
oxygen
Relative humidity
production*
1999
(mbar)
(per minute)
consumption
at start
at end
increase
(%)
2/13
1028.1
78.4
100%
34%
36%
2%
−61
2/14
1029.4
83.8
108%
33%
35%
3%
−31
2/15
1026.1
116.8
178%
32%
46%
14%
+20
2/16
1014.9
109.6
164%
33%
43%
10%
+5
2/17
1012.9
114.8
174%
34%
48%
14%
+16
2/18
1015.6
116.8
178%
35%
48%
13%
+20
2/19
1021.7
109.0
162%
35%
46%
11%
+4
2/20
1016.8
122.4
188%
36%
52%
16%
+32
2/21
1014.8
123.5
192%
41%
58%
17%
+34
2/22
1003.3
115.1
174%
40%
54%
14%
+16
2/23
1011.6
102.1
148%
35%
45%
10%
−11
2/24
1010.3
116.8
178%
34%
48%
14%
+20
2/25
1019.3
79.3
102%
36%
38%
2%
−59
2/26
1021.4
82.7
110%
34%
38%
4%
−52
2/27
1016.1
123.5
190%
33%
48%
15%
+34
2/28
1024.3
75.6
96%
36%
39%
3%
−67
3/1
1024.6
115.6
176%
36%
49%
13%
+17
3/2
1019.5
113.5
172%
38%
55%
17%
+13
3/3
1004.6
114.8
174%
39%
55%
16%
+16
3/4
995.2
116.5
178%
40%
55%
15%
+19
3/5
995.4
118.0
180%
38%
44%
16%
+22
3/6
1002.3
113.3
170%
35%
48%
14%
+12
*Deviations from the average of all the tests
It is known that the oxygen uptake can be determined by measuring the heart rate as a function of the mechanical exertion. This ergometric method is based on establishing the oxygen transport volume through the action of the heart. Since the stroke volume is essentially constant irrespective of the intensity of the mechanical work, and the increased oxygen demand caused by the increase in work results in an increase in the heart rate, the quantity of the transported oxygen can be established by determining the additional heartbeats caused by the work. A 3-stage ergometer as recommended by the World Health Organization (WHO) is used in physiology research institutes and fitness clubs around the world.
The working muscle utilizes glycogen and fatty acids together to obtain energy. Muscle glycogen is broken down anaerobically. Fatty acid breakdown is dependent on molecular oxygen. If the glycogen reserves are exhausted and only fats remain available, the oxygen demand increases and thus the heart rate does too. At constant exertion if muscle glycogen is present therefore the heart rate increases slightly after the start of the mechanical exertion and remains at a low level as long as glycogen is available. After it is exhausted, there is a renewed increase to a higher level which is to be ascribed to exclusive utilization of fats. The oxygen transport volume of the action of the heart can therefore be determined by establishing the number of heartbeats at two different physical exertions, which are, however, each
Barts Samuel
Krishnan Ganapathy
Leydig , Voit & Mayer, Ltd.
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