WO2005074950A1 - Utilisation de lait de jument pour la production d'une preparation destinee a ameliorer la qualite du sperme - Google Patents

Utilisation de lait de jument pour la production d'une preparation destinee a ameliorer la qualite du sperme Download PDF

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Publication number
WO2005074950A1
WO2005074950A1 PCT/AT2005/000038 AT2005000038W WO2005074950A1 WO 2005074950 A1 WO2005074950 A1 WO 2005074950A1 AT 2005000038 W AT2005000038 W AT 2005000038W WO 2005074950 A1 WO2005074950 A1 WO 2005074950A1
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WO
WIPO (PCT)
Prior art keywords
acid
omega
milk
study
vitamin
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Application number
PCT/AT2005/000038
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German (de)
English (en)
Inventor
Andreas Jungwirth
Gertrude Markolin
Norbert Fuchs
Peter Kössler
Original Assignee
Nutropia Ernährungsmedizinische Forschungs Gmbh
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Application filed by Nutropia Ernährungsmedizinische Forschungs Gmbh filed Critical Nutropia Ernährungsmedizinische Forschungs Gmbh
Publication of WO2005074950A1 publication Critical patent/WO2005074950A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/20—Milk; Whey; Colostrum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis

Definitions

  • the present invention relates to the use of mare's milk.
  • Infertility is defined as the inability to achieve pregnancy within one year of unprotected sex. Without contraception, couples are usually 80-85% likely to get pregnant within 12 months.
  • Fertility depends on both the male and female factors. Approximately 20% of all cases of subfertility are due to the male factor alone. In 27% of cases, both the male and female factors are responsible. From this, the male factor plays a role in subfertility in 50% of all subfertile couples. The proportion of infertile men in the adult male population is estimated at 6%. Studies indicate that one reason for the deterioration in sperm quality can be found in environmental influences, e.g. in occupational exposure to various chemicals, heat and heavy metals. Exposure to pesticides and estrogens, lifestyle factors and malnutrition also have a negative impact on sperm quality.
  • sperm motility can be improved in men with a low selenium status by daily supplementation with selenium or selenium in combination with vitamins A, C and E over a period of 90 days.
  • the trace element zinc is essential for an intact function of the male reproductive system.
  • Zinc is a cofactor of more than 200 enzymes.
  • a zinc deficit is associated with reduced testosterone levels and a reduced sperm count.
  • amino acid arginine acts as a biochemical precursor in the synthesis of putrezin, spermidine and spermin, substances that are believed to play a crucial role in sperm motility.
  • spermatozoa contains a much higher proportion of polyunsaturated fatty acids than somatic cells. For this reason, they are more sensitive to oxidation by reactive oxygen species, which cause the lipid peroxidation of membrane lipids propagated by so-called radical chain reactions. Because many sperm functions depend on membrane function, oxidation of these lipids can result in a drastic loss of sperm functions. So z. For example, a significant loss of motility (up to immotility), a reduction in oolem binding and penetration ability or a reduction in membrane integrity been written.
  • oxidative damage to spermatozoa is closely correlated with inflammatory processes in the genital tract and the appearance of activated leukocytes, in particular granulocytes, which produce more than 100 times as much ROS as spermatozoa in the context of their natural function as a defense against infection.
  • the problem is solved by using mare's milk to produce a preparation for the treatment of infertility. Surprisingly, it has been shown that the probability of pregnancy in couples in which either the man or the woman is considered sterile is significantly increased.
  • the preparation is comprehensively suitable for mare's milk both for male and female use.
  • mare's milk in nutritional medicine, inter alia for the treatment of skin diseases, in particular also as a food additive in the treatment of neurodermatitis and psoriasis, and successful use of native mare's milk in newborns has also been described.
  • mare's milk In comparison to cow's milk, mare's milk has a composition very similar to that of human milk and has a higher proportion of essential highly unsaturated fatty acids and phospholipids which are important for the skin metabolism, although the absolute fat content of mare's milk is lower than that of cow's milk.
  • Mare's milk also contains above-average proportions of natural antioxidant nutrients such as e-vitamins, vitamin C and vitamin B12. Surprisingly, it has now been shown that some couples who could not achieve pregnancy within one year if they had unprotected sexual intercourse became pregnant within 3 months after taking mare's milk.
  • the preparation is preferably used to improve the sperm concentration, vitality, motility, function and / or morphology. It has been shown that after taking Mare's milk improves the sperm (spermatozoa) concentration, vitality, motility, function and / or morphology within 3 months. If one of these parameters is already improved, the likelihood of fertilization is increased, ie the improvement of one of these parameters is sufficient to treat infertility. Preferably two or more of these parameters are improved by taking the mare's milk.
  • the preparation can include other ingredients, in particular flavors, preservatives, colors and, depending on the consistency, solvents, emulsifiers, thickeners, carriers and the like.
  • the mare's milk is particularly preferably provided as a dry concentrate.
  • the drying can be carried out, for example, by freeze drying, spray drying or evaporation. Drying provides a durable preparation in which the high-quality ingredients can be stored for long periods of time without any loss in quality.
  • the dry concentrate can be converted to another form if necessary, e.g. by dissolving in water in a liquid for ingestion as a drink or the like.
  • the mare's milk is provided on a biologically inert, highly disperse matrix, preferably a silicon dioxide matrix.
  • a biologically inert, highly disperse matrix preferably a silicon dioxide matrix.
  • This mare's milk preparation has a shelf life of more than 24 months and it is possible in this way to combine mare's milk with other functional nutrients (in particular vitamins, minerals, trace elements, highly unsaturated fatty acids, etc.), as the temperature in such a drying process and oxygen-sensitive ingredients are not destroyed.
  • the mare's milk is vacuum evapo- rated at temperatures below 40 ° C and under oxygen finally dried and concentrated.
  • the mare's milk concentrate is a viscous amorphous mass that is difficult to process galenically in this form.
  • inert, highly disperse silicon dioxide silicon dioxide
  • silicon is added to the mare's milk before the vacuum distillation as a carrier matrix, so that a crystalline, powdery dry concentrate results after the vacuum distillation.
  • highly disperse matrix is a matrix according to the invention having a surface area of at least 50m 2 / g, preferably at least 100m 2 / g, more preferably at least 150m 2 / g, more preferably at least 200m 2 / g and most preferably at least 400m 2
  • the provision of a biologically inert matrix does not chemically alter the mare's milk so that it does not lose its biological value.
  • the average particle size of the matrix is preferably approximately 900 nm, preferably 500 nm, particularly preferably 250 nm, lOOnm maximum , maximum 50nm, maximum 25nm and most preferably maximum 15nm.
  • the preparation preferably also comprises at least one essential fatty acid, in particular at least one vegetable essential fatty acid.
  • essential fatty acids in particular of vegetable essential fatty acids
  • the addition of essential fatty acids, in particular of vegetable essential fatty acids, has proven to be particularly advantageous, since a connection between fertility and altered lipid metabolism in sperm can also be seen:
  • the lipid composition of the sperm membrane has a significant influence on the functional properties of the spermatozoa. Linolenic acid, stearidonic acid, eicosadienolic acid, linoleic acid, palmitolenic acid, vaccenic acid, eicosenoic acid, erucic acid, nervonic acid and oleic acid are suitable.
  • the essential fatty acid is selected from the group consisting of omega-3-FS-alfa-linolenic acid, omega-3-FS-stearidonic acid, omega- ⁇ -FS-eicosadienolic acid, omega-6-FS -gamma-linolenic acid, omega-6-FS-linoleic acid, omega-7-FS-palmitoleic acid, omega-7-FS-vaccenic acid, omega-9-FS-eicosenoic acid, omega-9-FS-erucic acid, omega-9-FS -Nervonic acid, omega-9-FS-oleic acid.
  • These fatty acids act specifically on the above-mentioned spermatozoa. zoen properties.
  • the preparation preferably further comprises at least one substance selected from the group consisting of L-arginine, inositol, vitamin C, vitamin E, hydrogen carbonate, potassium, citrate, carbonate, alpha-lipoic acid, calcium, magnesium, choline, taurine, niacin, Zinc, pantothenic acid, iron, beta carotene, vitamin B ⁇ , vitamin B2, vitamin Bl, manganese, copper, sodium, biotin, folic acid, molybdenum, selenium, xanthan, fructose, citric acid and vitamin B12 or a combination of at least two of these substances.
  • at least one substance selected from the group consisting of L-arginine, inositol, vitamin C, vitamin E, hydrogen carbonate, potassium, citrate, carbonate, alpha-lipoic acid, calcium, magnesium, choline, taurine, niacin, Zinc, pantothenic acid, iron, beta carotene, vitamin B ⁇ , vitamin B2, vitamin Bl,
  • This composition has been shown to be particularly suitable for the treatment of infertility, since it contains hydrophilic and lipophilic antioxidants with different redox potentials and thus protects both aqueous and lipophilic structures from various partially damaging radicals, peroxides and other oxygen species. These antioxidants have a synergistic effect, since through their mutual regeneration (recycling) each have a saving effect on the other without being able to replace each other.
  • FIG. 1 showing the results of the male patients
  • 2 shows the results of the female patients
  • Figure 3 shows the results of all patients.
  • Nutrient concentrate II was administered to 30 couples with desire to have children and diagnosed idiopathic infertility for 3 months once a day, nutrient concentrate II having the following composition:
  • Controls were carried out for the male partner after 2 and 3 months, in which a spermiogram and a rough clinical examination were carried out.
  • the data analysis was carried out with SPSS 9.0. The changes between the pre-value and the final control were checked with the Students t-test for connected samples. The significance level was set to p ⁇ 0.05.
  • the spermiogram and quality of life tests were carried out at the scheduled times.
  • the large variation in this determination was striking.
  • the minimum was 1.0 million / ml, the maximum was 230.0 million / ml, and the standard deviations were above the mean.
  • the cross table showed that 16 patients did not reach the normal value before and at the end of the study. 2 patients who had normal sperm vitality before the start of the study were below the norm at the end of the study. However, there were also 6 patients whose sperm vitality was below the norm before the start of the study, but who showed a finding in the normal range at the end of the study.
  • Table 11 Cross table for relationships between pre and post values (motility a) related to the norm limit. number
  • the criterion of at least 20% improvement was achieved for the mobility criteria a + b for 12 of the 29 spermiograms.
  • the percentage of sperm that was found to be immobile decreased from a mean pre-reading of 51.24 +/- over the course of the study
  • the aim of the study was to answer the question of how many study participants had an improvement of at least 20% in at least one of the 4 target criteria for the spermiogram while taking nutrient concentrate II, i.e. achieve a response.
  • the questionnaire SF-36 was used for the subjective assessment of the health-related quality of life.
  • the SF-36 contains eight dimensions (subscales), which are formed from the answers of two to ten items (questions).
  • the subscales were calculated according to the instructions in the SF-36 manual (M. Bullinger, I. Kirchberger, 1998). The scales are calculated so that a higher value corresponds to a better state of health.
  • the evaluation was carried out separately for the male and female partners and an additional evaluation was carried out for the entire group.
  • the scales were only calculated when at least 50% of the items of a questionnaire were answered.
  • the physical role function indicates the extent to which physical health affects work or other daily activities, e.g. coping less than usual, restrictions on the type of activities or difficulties in carrying out certain activities.
  • the assessment of the physical role function was neither significantly changed in the men nor in the women and also not for the whole group in the course of the study. There was only a trend towards a higher score at the end of the study.
  • the mean baseline values (93.10 points) of the men in this study were above the baseline values of a norm sample (91.43 points), the values for women were 87.93 below the values of a norm sample (88.99 points).
  • Table 16 Men; Vitality (Items 9a, 9e, 9g, 9i) / Social Functionality (Items 6 and 10)
  • the emotional role function subscale assesses the extent to which emotional problems affect work or other daily activities.
  • Fig. 1 shows the results of the male patient, in
  • Fig. 2 shows the results of the female patients and in Fig. 3 the results of all patients are shown.
  • B stands for baseline and K for control.
  • Fig. 1 Significant changes between baseline and control 2: * p ⁇ 0.05 ** p ⁇ 0.01
  • Fig. 2 Significant changes between baseline and control 2: * p ⁇ 0.05 ** p ⁇ 0.01

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Reproductive Health (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne l'utilisation de lait de jument pour la production d'une préparation destinée à être utilisée pour le traitement de la stérilité.
PCT/AT2005/000038 2004-02-10 2005-02-04 Utilisation de lait de jument pour la production d'une preparation destinee a ameliorer la qualite du sperme WO2005074950A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT0019404A AT503484A1 (de) 2004-02-10 2004-02-10 Verwendung von stutenmilch zur herstellung eines präparats zur behandlung von unfruchtbarkeit
ATA194/2004 2004-02-10

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WO2005074950A1 true WO2005074950A1 (fr) 2005-08-18

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008031131A1 (fr) * 2006-09-14 2008-03-20 Soba Biotec Gmbh Procédé de production d'une préparation à base de lait de jument
CN101861893A (zh) * 2010-03-04 2010-10-20 云南大学 神经酸锌在婴幼儿母乳化配方奶粉中的应用
WO2012076680A1 (fr) * 2010-12-09 2012-06-14 Gonadosan Gmbh Préparation combinée destinée à améliorer la fertilité chez la femme

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003090728A1 (fr) * 2002-04-25 2003-11-06 Nutropia Ernährungsmedizinische Forschungs Gmbh Utilisation d'un concentre de lait de jument seche sur une matrice biologiquement inerte, fortement dispersee

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003090728A1 (fr) * 2002-04-25 2003-11-06 Nutropia Ernährungsmedizinische Forschungs Gmbh Utilisation d'un concentre de lait de jument seche sur une matrice biologiquement inerte, fortement dispersee

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BROWN, L.M.: "Treating Infertility Naturally", INTERNET ARTICLE, 27 January 2004 (2004-01-27), XP002331084, Retrieved from the Internet <URL:http://www.babyzone.com/features/content/display.asp?TopicID=28&ContentID=141&Page=1> [retrieved on 20050608] *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008031131A1 (fr) * 2006-09-14 2008-03-20 Soba Biotec Gmbh Procédé de production d'une préparation à base de lait de jument
CN101861893A (zh) * 2010-03-04 2010-10-20 云南大学 神经酸锌在婴幼儿母乳化配方奶粉中的应用
WO2012076680A1 (fr) * 2010-12-09 2012-06-14 Gonadosan Gmbh Préparation combinée destinée à améliorer la fertilité chez la femme

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