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ES2528331A1 - Composition with effect on bone and cardiovascular health - Google Patents

Composition with effect on bone and cardiovascular health Download PDF

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Publication number
ES2528331A1
ES2528331A1 ES201331232A ES201331232A ES2528331A1 ES 2528331 A1 ES2528331 A1 ES 2528331A1 ES 201331232 A ES201331232 A ES 201331232A ES 201331232 A ES201331232 A ES 201331232A ES 2528331 A1 ES2528331 A1 ES 2528331A1
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ES
Spain
Prior art keywords
beta
composition
cryptoxanthin
campesterol
stigmasterol
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
ES201331232A
Other languages
Spanish (es)
Other versions
ES2528331B1 (en
Inventor
Fernando Granado Lorencio
Amparo ALEGRÍA TORÁN
Reyes BARBERÁ SÁEZ
Guadalupe GARCÍA LLATAS
Mª Jesús LAGARDA BLANCH
Luis Manuel SÁNCHEZ SILES
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Maria Elena Hernandez Alvarez
Original Assignee
Hero AG
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta Del Hierro
Universitat de Valencia
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hero AG, Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta Del Hierro, Universitat de Valencia filed Critical Hero AG
Priority to ES201331232A priority Critical patent/ES2528331B1/en
Publication of ES2528331A1 publication Critical patent/ES2528331A1/en
Application granted granted Critical
Publication of ES2528331B1 publication Critical patent/ES2528331B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Steroid Compounds (AREA)

Abstract

La presente invención hace referencia a una composición que comprende beta-criptoxantina, campesterol, beta-sitosterol, estigmasterol, sitostanol, campestanol y, de al menos un excipiente farmacéuticamente aceptable. La presente invención además comprende el uso de dicha composición para la manufactura de un medicamento; en concreto de un medicamento para la prevención y/o tratamiento de osteoporosis y enfermedades cardiovasculares. Adicionalmente, la presente invención también comprende un producto comestible, preferentemente como suplemento dietético, que comprende una cantidad efectiva de beta-criptoxantina, campesterol, beta-sitosterol, estigmasterol, sitostanol, campestanol y cantidades adecuadas de otros ingredientes comestibles, para el tratamiento y/o prevención de enfermedades cardiovasculares y osteoporosis.The present invention refers to a composition comprising beta-cryptoxanthin, campesterol, beta-sitosterol, stigmasterol, sitostanol, campestanol, and at least one pharmaceutically acceptable excipient. The present invention further comprises the use of said composition for the manufacture of a medicament; specifically a medicine for the prevention and/or treatment of osteoporosis and cardiovascular diseases. Additionally, the present invention also comprises an edible product, preferably as a dietary supplement, comprising an effective amount of beta-cryptoxanthin, campesterol, beta-sitosterol, stigmasterol, sitostanol, campestanol and suitable amounts of other edible ingredients, for treatment and/or or prevention of cardiovascular diseases and osteoporosis.

Description

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P201331232 P201331232

06-08-2013 06-08-2013

En la tabla 2 se muestra la bioaccesibilidad de la beta-criptoxantina y de los esteroles vegetales totales e individuales de las composiciones 1, 2 y 3 del ejemplo 1. Table 2 shows the bioaccessibility of beta-cryptoxanthin and of the total and individual plant sterols of compositions 1, 2 and 3 of Example 1.

Tabla 2. Bioaccesibilidad (%), expresada como media y en paréntesis el intervalo de confianza al nivel de probabilidad del 95%. Table 2. Bioaccessibility (%), expressed as a mean and in brackets the confidence interval at the 95% probability level.

Composición Composition

1 one
2 3 2 3

beta-criptoxantina beta-cryptoxanthin
83 (70-93) -- 90 (84-97) 83 (70-93) - 90 (84-97)

Campesterol Campesterol
-- 8.31 (6.70-9.93) 6.66 (5.99-7.33) - 8.31 (6.70-9.93) 6.66 (5.99-7.33)

Estigmasterol Stigmasterol
-- 5.96 (4.47 7.45) 4.02 (3.75-4.29) - 5.96 (4.47 7.45) 4.02 (3.75-4.29)

Sitosterol Sitosterol
-- 6.42 (5.18-7.66) 4.15 (4.05-4.25) - 6.42 (5.18-7.66) 4.15 (4.05-4.25)

Campestanol Campestanol
-- 6.82 (5.40-8.24) 5.79 (4.42-7.16) - 6.82 (5.40-8.24) 5.79 (4.42-7.16)

Sitostanol Sitostanol
-- 6.05 (4.29-7.81) 4.41 (4.16-4.66) - 6.05 (4.29-7.81) 4.41 (4.16-4.66)

EV totales Total EV
-- 6.48 (5.19-7.77) 4.35 (4.20-4.50) - 6.48 (5.19-7.77) 4.35 (4.20-4.50)

EV= esteroles vegetales EV = plant sterols

Los intervalos de confianza de la Tabla 2 muestran que no hay diferencias en la The confidence intervals in Table 2 show that there are no differences in the

10 biodisponibilidad in vitro cuando las beta-criptoxantina y los esteroles vegetales de las composiciones están solos (composición 1 y 2, respectivamente) o juntos (composición 3). 10 bioavailability in vitro when beta-cryptoxanthin and plant sterols of the compositions are alone (composition 1 and 2, respectively) or together (composition 3).

Ejemplo 3: Evaluación de la biodisponibilidad in vivo Example 3: Evaluation of bioavailability in vivo

15 Se proporcionaron las tres composiciones del ejemplo 1 a 36 sujetos. En concreto, se seleccionaron mujeres en edad post-menopáusica, grupo de alto riesgo de desmineralización ósea y desarrollo de enfermedad cardiovascular. La selección se realizó mediante muestreo no-probabilístico. Se administró cada una de las The three compositions of Example 1 were provided to 36 subjects. Specifically, women in post-menopausal age, high-risk group of bone demineralization and development of cardiovascular disease were selected. The selection was made by non-probabilistic sampling. Each of the

20 composiciones del ejemplo 1 una vez al día durante 4 semanas (t=4), dejando un 20 compositions of Example 1 once a day for 4 weeks (t = 4), leaving a

10 10

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P201331232 P201331232

06-08-2013 06-08-2013

Tabla 3. Concentraciones séricas de los compuestos durante los tratamientos Table 3. Serum concentrations of the compounds during treatments

t=0 t = 0
t=4 % de cambio t=0, t=4) Incremento neto t = 4 % change t = 0, t = 4) Net increase

Composición 1 Composition 1

Beta-criptoxantinaBeta-cryptoxanthin
16.9 (13.7-20.1) 56.5 (50.0-63.0)a 310 (222-398) 36.4 (29.9-43.0)  16.9 (13.7-20.1) 56.5 (50.0-63.0) a 310 (222-398) 36.4 (29.9-43.0)

Composición 2 Composition 2

Beta-sitosterol Beta sitosterol
4.0 (3.46-4.54) 6.34 (4.7-7.98) 64.32 (34.4392.21) 10 2.36 (0.94-3.78) 4.0 (3.46-4.54) 6.34 (4.7-7.98) 64.32 (34.4392.21) 10 2.36 (0.94-3.78)

Campesterol Campesterol
3.06 (2.7-4.20) 3.28 (2.943.62) 12.7 (4.42, 20.98) 0.29 (0.04-5.54) 3.06 (2.7-4.20) 3.28 (2,943.62) 12.7 (4.42, 20.98) 0.29 (0.04-5.54)

Estigmasterol Stigmasterol
0.50 (0.38-0.58) 0.48 (0.380.58) 14.2 (8.06,36.46) 15 -0.01 (-0.12-0.10) 0.50 (0.38-0.58) 0.48 (0.380.58) 14.2 (8.06.36.46) 15 -0.01 (-0.12-0.10)

Desmosterol Desmosterol
0.58 (0.45-0.64) 0.65 (0.59,0.71) 15.48 (8.61, 22.35) 0.07 (0.03-0.11) 0.58 (0.45-0.64) 0.65 (0.59.0.71) 15.48 (8.61, 22.35) 0.07 (0.03-0.11)

Latosterol Latosterol
2.91 (2.47-3.35) 3.13 (2.673.59) 14.86 (2.41, 27.31) 20 0.17 (-0.16-0.50) 2.91 (2.47-3.35) 3.13 (2,673.59) 14.86 (2.41, 27.31) 20 0.17 (-0.16-0.50)

Composición 3 Composition 3

Beta-criptoxantinaBeta-cryptoxanthin
17.8 (13.921.6) 53.2 (47.3-59.0)a 282 (198365) 34.5 (29.939.2)  17.8 (13,921.6) 53.2 (47.3-59.0) a 282 (198365) 34.5 (29.939.2)

Beta-sitosterol Beta sitosterol
3.91 (3.45-4.37) 5. 46 (4.39-6.53) 49.36 (24.8173.92) 25 1.56 (0.65-2.47) 3.91 (3.45-4.37) 5. 46 (4.39-6.53) 49.36 (24.8173.92) 25 1.56 (0.65-2.47)

Campesterol Campesterol
2.91 (2.66-3.16) 3.25 (2.83-3.67) 10.75 (3.07, 18.43) 0.34 (0.08-0.60) 2.91 (2.66-3.16) 3.25 (2.83-3.67) 10.75 (3.07, 18.43) 0.34 (0.08-0.60)

Estigmasterol Stigmasterol
0.5 (0.41-0.58) 0.48 (0.40-0.55) 8.94 (-8.12, 26.0) 30 -0.02 (-0.11-0.07) 0.5 (0.41-0.58) 0.48 (0.40-0.55) 8.94 (-8.12, 26.0) 30 -0.02 (-0.11-0.07)

Desmosterol Desmosterol
0.62 (0.58-0.66) 0.63 (0.62-0.65) 2.91 (-3.71, 9.53) 0.01 (-0.03-0.05) 0.62 (0.58-0.66) 0.63 (0.62-0.65) 2.91 (-3.71, 9.53) 0.01 (-0.03-0.05)

Latosterol Latosterol
3.21 (2.74-3.68) 3.13 (2.70-3,56) 1.29 (-7.8810.46) 35 -0.08 (-0.36-0.20) 3.21 (2.74-3.68) 3.13 (2.70-3.56) 1.29 (-7.8810.46) 35 -0.08 (-0.36-0.20)

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Claims (1)

imagen1image 1 imagen2image2
ES201331232A 2013-08-06 2013-08-06 Composition with effect on bone and cardiovascular health Active ES2528331B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
ES201331232A ES2528331B1 (en) 2013-08-06 2013-08-06 Composition with effect on bone and cardiovascular health

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES201331232A ES2528331B1 (en) 2013-08-06 2013-08-06 Composition with effect on bone and cardiovascular health

Publications (2)

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ES2528331A1 true ES2528331A1 (en) 2015-02-06
ES2528331B1 ES2528331B1 (en) 2015-12-02

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008154294A1 (en) * 2007-06-07 2008-12-18 Unicity International, Inc. Method and composition for providing controlled delivery of biologically active substances
US20090264520A1 (en) * 2008-04-21 2009-10-22 Asha Lipid Sciences, Inc. Lipid-containing compositions and methods of use thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008154294A1 (en) * 2007-06-07 2008-12-18 Unicity International, Inc. Method and composition for providing controlled delivery of biologically active substances
US20090264520A1 (en) * 2008-04-21 2009-10-22 Asha Lipid Sciences, Inc. Lipid-containing compositions and methods of use thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ALEMANY LAIA et al. Effect of simulated gastrointestinal digestion on plant sterols and their oxides in enriched beverages.FOOD RESEARCH INTERNATIONAL ELSEVIER APPLIED SCIENCE, BARKING, GB // Junio 2013; VOL: 52 No: 1 Pags: 1 - 7 ISSN 0963-9969 Doi: doi:10.1016/j.foodres.2013.02.024 Gong Joshua; Goff H Douglas *

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