Composition comprising fertilized shell eggs

Fertilized incubated shell eggs, e.g. avian eggs and in particular hens eggs, may be used to produce a composition which acts to enhance sexual potency (or libido) and elevate blood testosterone levels.

The present invention relates to the use of fertilized shell eggs to 
enhance sexual potency (libido), and to compositions comprising such eggs 
or extracts thereof. 
Human sex drive is affected by many factors, such as gender, age, stress 
levels, and psychological factors. Reduced sex drive affects the general 
physical and mental well-being of those concerned and is a cause for 
concern not just for the individual so afflicted but also for his or her 
sexual partner. 
Over the ages many substances have been prepared for enhancing sex drive, 
but most have not been proven to have any positive effect. 
Those treatments with proven success generally fall into two 
categories--treatment with hormones such as testosterone and treatment 
with vasodilatory drugs. Vasodilators have a direct physical effect, 
facilitating erection, rather than affecting the individual's libido or 
sex drive. On the other hand, with many males low sex drive correlates to 
low testosterone levels and in these circumstances testosterone 
administered by injection or transdermally has shown some success. The 
success however is limited to those whose testosterone level is 
low--testosterone therapy has not generally been found to be effective in 
increasing sex drive in the normal adult. 
We have now found however that sex drive can be increased by administration 
into the gastrointestinal tract of fertilized shell eggs, i.e. reptile or 
avian eggs, or compositions derived therefrom. 
As described further below this surprising effect has been proven in double 
blind clinical trials. 
In these trials it has been shown that the subjects having low testosterone 
levels may have those levels significantly increased. Nonetheless, unlike 
direct testosterone therapy, the treatment enhances sex drive even in 
individuals with normal testosterone levels. 
Thus viewed from one aspect this invention provides a method of treatment 
of the human or non-human mammalian body to increase libido or to enhance 
body testosterone levels, said method comprising administering to said 
body, preferably into the gastrointestinal tract thereof, e.g. rectally or 
more preferably orally, a therapeutic agent deriving from fertilized, 
incubated shell eggs. 
By a shell egg is meant an animal egg (e.g. bird or reptile egg) having an 
opaque shell. 
Particularly preferably, the eggs used will be avian eggs, especially those 
from birds bred for egg production, e.g. hens, geese, ducks, quail, 
turkeys, ostriches, pheasants, pigeons or the like, most especially hens. 
As shown by the trials reported below, the libido enhancing effect occurs 
with fertilized and incubated eggs rather than with unfertilized and/or 
unincubated eggs. It is believed that this is as a result of the 
production of the active factors in the transformation of the egg yolk 
during embryogenesis. 
In the general production of eggs for human consumption, the eggs used are 
either unfertilized or majoritively unfertilized, and even if fertilized 
eggs are (inadvertently) presented for human consumption these will 
generally be unincubated eggs or eggs which have been incubated only for 1 
or 2 days. 
The eggs used according to the invention are desirably ones in the 
blastodermal and subsequent preembryonic to protoembryonic stages in which 
yolk transformation has begun, but the organs of the embryo are barely if 
at all discernible; this corresponds essentially to the subembryonic 
liquid stage of embryogenesis (generally 3 to 14 days incubation for a 
hen's egg), or the period up to the acceleration of calcium uptake by the 
embryo (this occurs after about 15 days incubation for the hen's egg). 
In the case of fertilized hens' eggs used according to the invention, the 
incubation period is preferably 2 to 15 days especially 3 to 12, 
particularly 5 to 10, and most preferably about 9 or about 10 days. Eggs 
incubated for such periods would generally not be considered fit for human 
consumption due to the degree of transformation of the yolk that has 
occurred and, for the upper limit due to the presence of an embryo with 
visible organs. 
Viewed from a further aspect the present invention also provides the use of 
fertilized incubated shell egg for the manufacture of an agent for use in 
treatment of the human or non-human mammalian body to increase libido. 
Viewed from yet a further aspect the present invention provides the use of 
fertilized incubated shell egg for the manufacture of an agent for use in 
treatment of the human or non-human mammalian body to enhance testosterone 
levels therein.

EXAMPLE 1 
Egg Powder Preparation 
Fertilized eggs were collected daily from laying hens, subjected to a 
surface gassing to sterilize their outer surfaces and placed into storage 
at 11.degree. C. until a week's batch had been collected. Storage at 
11.degree. C. halts embryogenesis and during this period the eggs are 
rolled to prevent settling out of the contents. The collected week's batch 
was placed in an incubator maintained at about 39.degree. C. and a 
relative humidity of about 80%. In the incubator an automatic turner 
turned the eggs two to three times per day. After five days incubation the 
eggs are illuminated to determine which were not developing and these were 
removed. (They can be used for animal feed). After 9 days incubation the 
eggs were removed, dipped in 70% ethanol, cracked open in a sterile room, 
and the contents were mixed and placed in a freeze drier. The egg contents 
were freeze dried to about 2 weight % moisture content over a period of 
two days at about -50.degree. to -60.degree. C. under vacuum. The crisp, 
flaky freeze dried product was ground and vacuum packed before further 
processing as described in Example 2 below. 
EXAMPLE 2 
Oral Composition 
Each foil sealed sachet contains 3.5 g powder having the following 
composition: 
______________________________________ 
% by weight 
______________________________________ 
Dried egg powder 72.10 
(Example 1 above) 
Glucose 1.40 
Fructose 0.70 
Potassium citrate 1.10 
Sodium citrate 1.40 
Magnesium chloride 
0.70 
Zinc oxide 1.10 
.beta.-carrotene 0.70 
Ascorbic acid 5.50 
.alpha.-tocopherol 
6.10 
(premix*-0.01% active) 
Vitamin B.sub.12 2.10 
(premix*-5% active) 
Folic acid 0.70 
(premix*-0.5% active) 
Thiamine chloride 0.30 
(premix*-25% active) 
Plant extracts: 
Ginseng 1.80 
Aniseed 1.60 
Rosemary 0.70 
Peppermint 0.40 
Hop 0.20 
Camomile 0.30 
Thyme 0.30 
Clove 0.30 
Fennel 0.50 
______________________________________ 
* -- premix manufactured from textured maize starch. 
For administration, the contents of one sachet is mixed into water or a 
drink such as milk or orange juice, and swallowed. For normal treatment 
one sachet is taken morning and evening. 
EXAMPLE 3 
First Trial 
To document the effect of the egg powder on sexual desire, a pilot study 
was carried out. Open studies have obvious weaknesses (bias, the effect of 
placebos, etc.). 
Accordingly, in order to validate the indications of an effect which were 
reported during the pilot studies, it was decided to carry out a 
controlled double-blind study. The objective of this study was to examine 
and compare to see whether the powder has any more effect on sexual desire 
than a placebo in a group of men. The study was arranged so as to be a 
randomized, placebo-controlled, double-blind study lasting over a period 
of six weeks. This means three weeks with the active preparation and three 
weeks with a placebo. 
Sixteen men without reported sexual dysfunction and whose ages ranged from 
47 to 60, the average age being 52.5 years, took part in the study. The 
average weight was 84 kg and the average height 181 cm. This gives a "Body 
Mass Index" (BMI) of 25.6 kg/m.sup.2, i.e. the persons were of normal 
weight. 
None of the participants used medication regularly. Half of the 
participants were given the preparation according to the invention for the 
first three weeks, while the remaining eight were given a placebo. In the 
second three weeks, the situation was reversed. 
The study was carried out as a cross-over study without a wash-out period 
between the two periods of treatment. This method was chosen because the 
number of persons in the test was smaller than in a parallel group method. 
Dried egg powder from 9 day incubation eggs prepared as in Example 1 was 
measured out into sachets of 3 g having the same relative composition as 
the material of Example 2, i.e. 72.1% egg powder, one sachet to be taken 
in the morning and one in the evening. The contents of the sachet were 
stirred into a glass of juice or water and drunk immediately. Each 
participant was given a box containing 50 sachets corresponding to three 
week's treatment together with an equivalent amount of the placebo. Unused 
sachets were returned in order to confirm compliance. 
The placebo used was identical to the preparation according to the 
invention other than that the egg powder therein derived from fresh, 
non-incubated, fertilized eggs. 
Further, the study was based on the participants' own evaluation of their 
sexual desire, judged by means of a 10 cm long visual analog scale, VAS. 
The participants made weekly evaluations of the changes in their sexual 
desire, both in the active period and in the placebo period. At the end of 
each period of treatment, an evaluation was also made of whether it was 
desirable to continue in the treatment. 
The participants were instructed in the use of visual analog scales and it 
was also made possible to give a response as to whether any side effects 
were registered as a consequence of the treatment. 
The participants were also instructed to report any discomfort. 
In Table 1 below the average score is shown of all the participants who 
were given the preparation according to the invention in the first period 
and the placebo in the second: 
TABLE 1 
______________________________________ 
Average score (N = 8) 
Preparation according to invention .fwdarw. placebo 
Week No. 1 2 3 4 5 6 
______________________________________ 
Score (cm) 
0.11 1.69 7.84 2.48 0.18 0.18 
______________________________________ 
As can be seen from the Table, there was an increase in the VAS value from 
week two, and high values in weeks three and four. 
In Table 2 below the average score is shown for the second group, viz the 
group which was given the placebo in the first period and the preparation 
according to the invention in the second period: 
TABLE 2 
______________________________________ 
Average score (N = 8) 
Placebo .fwdarw. preparation according to invention 
Week No. 1 2 3 4 5 6 
______________________________________ 
Score (cm) 
0 0.13 0.13 0.31 1.74 7.75 
______________________________________ 
As can be seen from the Table, the values are modest in the placebo period 
and there is a significant increase in the period when the preparation 
according to the invention was tested. 
Table 3 shows the average score for all the participants, by the week for 
the two periods: 
TABLE 3 
______________________________________ 
Average score for all participants (N = 16) 
Mean Score 
Week 1 Week 2 Week 3 
______________________________________ 
Period with preparation 
0.21 1.72 7.80 
according to invention 
Placebo period 1.24 0.16 0.25 
______________________________________ 
As can be seen from this Table, the preparation according to the invention 
gives a significantly higher value than the placebo in weeks two and 
three. The relatively high value for the placebo in week one is presumed 
to be due to a carry-over effect experienced by the participants who 
received the preparation according to the invention before changing over 
to the placebo. This is also made apparent in Table 1. Some of the effect 
of the preparation according to the invention is carried over into the 
first week of the placebo period since, as mentioned hereinabove, no 
wash-out period was used between the observation periods. 
FIG. 1 of the accompanying drawings displays graphically the change over 
time of the VAS score for one participant who was given the preparation 
according to the invention in the first period and the placebo in the 
second. 
The preparation according to the invention thus seems, according to these 
results, to take effect after two to three weeks treatment. 
None of the participants in this study reported any discomfort or side 
effects in connection with the treatment. 
The conclusion drawn from this first trial was that the preparation 
according to the invention really does have an effect on sexual desire and 
therefore, meets a long felt need, especially for those groups of 
vulnerable persons whose sexual desire is reduced to a greater or lesser 
extent owing to natural or therapeutic reasons. 
EXAMPLE 4 
Second Trial 
A second trial was subsequently carried out under more stringent conditions 
using the product of Example 2 as the test material and using as the 
placebo a product identical thereto other than in the replacement of the 
egg powder by 72.10% of a powder deriving from baked wheat rolls and corn 
flakes. The additional ingredients dominated the overall taste of the 
compositions making discrimination between active product and placebo by 
taste non-feasible. 
For the second trial 31 men, aged between 38 and 65 years (average 50.9), 
and admitting to reduced sexual desire were selected. The patients had a 
clinical examination and blood testosterone was measured. For patients 
whose initial blood testosterone values were low, blood testosterone was 
measured at the end of treatment. For these patients (total 11) an average 
increase of 25% in blood testosterone was found. 
The dosage used was 7 g/day of the composition of Example 2 (or the 
placebo) administered orally morning and evening. 
The trial was a multiple cross over double-blind with patients receiving 
placebo or active composition for a total of twelve weeks for alternating 
two week periods. 
Certain patients demonstrated a clear saw-tooth pattern as demonstrated for 
patients 17 (open squares) and 20 (filled squares) in FIG. 2 of the 
accompanying drawings. For others, an initial strong response led to 
subsequent stabilization of libido at a high plateau level (see patient 1 
(open squares) in FIG. 3 of the accompanying drawings). Other patients, 
especially those with low initial testosterone levels took more time to 
show a response in terms of increased sex drive. For such patients it is 
considered that the active agent would have to be administered for a more 
prolonged period. 
Overall, for this group of sexually dysfunctional men, a positive response 
in terms of increased libido was noted by 58% over the test period.