WO2017192535A1 - Method of treating cardiovascular disease and cystic fibrosis with combination product containing hydroxytyrosol - Google Patents

Method of treating cardiovascular disease and cystic fibrosis with combination product containing hydroxytyrosol Download PDF

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Publication number
WO2017192535A1
WO2017192535A1 PCT/US2017/030566 US2017030566W WO2017192535A1 WO 2017192535 A1 WO2017192535 A1 WO 2017192535A1 US 2017030566 W US2017030566 W US 2017030566W WO 2017192535 A1 WO2017192535 A1 WO 2017192535A1
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WO
WIPO (PCT)
Prior art keywords
vitamin
composition
hydroxytyrosol
cardiovascular disease
cystic fibrosis
Prior art date
Application number
PCT/US2017/030566
Other languages
French (fr)
Other versions
WO2017192535A8 (en
Inventor
Thomas GUTIERREZTHOMAS
Michael Pucci
Original Assignee
OliVentures, Inc.
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 OliVentures, Inc. filed Critical OliVentures, Inc.
Publication of WO2017192535A1 publication Critical patent/WO2017192535A1/en
Publication of WO2017192535A8 publication Critical patent/WO2017192535A8/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides

Definitions

  • the present invention relates to products containing hydroxytyrosol, plus an additional component, for the treatment of cardiovascular disease.
  • the present invention relates to a treatment with at least 10% hydroxytyrosol in combination with one or more other natural compositions for the treatment of cardiovascular diseases (CVD) and related conditions that are associated with CVD, which show an improvement over hydroxytyrosol treatment alone.
  • CVD cardiovascular diseases
  • CVD cardiovascular disease
  • hydroxytyrosol extracts which contain a high percentage of hydroxytyrosol can both treat and prevent CVD to some extent better than olive oils and other products containing a lower percentage of hydroxytyrosol. It is not a perfect solution, and, therefore, there needs to be products that treat CVD, reduce plaque buildup, and lower LDL blood levels.
  • the present invention results from the discovery that a number of products, in combination with a 10% or higher hydroxytyrosol composition, improve the prevention and treatment of CVD, cystic fibrosis (and related conditions) in a human subject in need of such treatment, as compared to treatment with hydroxytyrosol without the added compositions.
  • the present invention relates to an improved method of treating or preventing a cardiovascular disease, cystic fibrosis, or related condition in an individual, comprising administering to the individual a therapeutically effective amount of a composition comprising at least 10% hydroxytyrosol and at least one of a composition selected from the list consisting of:
  • vitamin B b) vitamin B; c) vitamin C;
  • compositions for treating or preventing a cardiovascular disease, cystic fibrosis, or related condition in an individual comprising a therapeutically effective amount of a composition containing at least 10% hydroxytyrosol w/w and at least one of a composition selected from the list consisting of:
  • the terms “a” or “an”, as used herein, are defined as one or as more than one.
  • the term “plurality”, as used herein, is defined as two or as more than two.
  • the term “another”, as used herein, is defined as at least a second or more.
  • the terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language).
  • the term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.
  • CVD cardiovascular disease
  • CAD cardiovascular disease
  • blood clots can form around the plaque and, if a clot moves into the heart, lungs, or brain, it can cause a stroke, heart attack, or pulmonary embolism.
  • Cystic fibrosis affects the cells that produce mucus, sweat, and digestive liquids. It causes these fluids to become thick and sticky, causing damage to the lungs and digestive system.
  • the term "related condition” refers to the process of arterial plaque buildup, increasing cholesterol, increasing low density lipoproteins (LDL) and the like, associated with the final deposition of plaque in the arteries. It also relates to related mucus problems associated with cystic fibrosis. By treating an individual, one can prevent these conditions from developing into CVD or, if already in a CVD condition, treating it by reversing these related conditions.
  • LDL low density lipoproteins
  • the term "individual” refers to a human person either suffering from CVD or cystic fibrosis, or in danger of suffering from CVD or cystic fibrosis.
  • composition refers to a nutritional composition of olive oil that has been extracted to isolate and concentrate the hydroxy tyrosol in the olive oil to a concentration of 10% or more. In one embodiment, it is present from about 10% to less than 20%. This can be done by a number of methods. As an example, an olive oil hydroxytyrosol fortified oil can be made based on the teaching of EP 2170090 or as taught in US application 14/002,920 (filed on November 4, 2013).
  • the term "at least one of an effective amount” refers to an addition of a composition that is synergistic or enhances the effect of the
  • hydroxytyrosol in treating or preventing CVD, cystic fibrosis, or a related condition.
  • compositions are incorporated into the olive oil extract. They can be done by means known in the art, including mixing, emulsification, dissolution and the like. One of skill in the art will be able to determine the proper amounts for the individual based on size, age, and the like, and be able to determine methods for incorporation of the extra items into the olive oil. The administration of the olive oil, then, is also by the same route as compositions designed to deliver hydroxytyrosol alone.
  • the term "therapeutically effective amount” refers to an amount of both the hydroxytyrosol and the at least one composition sufficient to treat or prevent symptoms or conditions of cardiovascular disease or related conditions, in an individual to a measurably greater extent than is known for hydroxytyrosol alone.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to an improved method for treating or preventing a cardiovascular disease or a related condition utilizing hydroxytyrosol and one of a vitamin or an anti-inflammatory.

Description

METHOD OF TREATING CARDIOVASCULAR DISEASE AND CYSTIC FIBROSIS WITH COMBINATION PRODUCT CONTAINING HYDROXYTYROSOL
This application claims priority to a US provisional application number 62/331 ,031 filed on May 03, 2016 and which is incorporated herein in its entirety by reference.
COPYRIGHT NOTICE
A portion of the disclosure of this patent contains material that is subject to copyright protection. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever.
BACKGROUND OF THE INVENTION
Field of the Invention
[001 ] The present invention relates to products containing hydroxytyrosol, plus an additional component, for the treatment of cardiovascular disease. In particular, the present invention relates to a treatment with at least 10% hydroxytyrosol in combination with one or more other natural compositions for the treatment of cardiovascular diseases (CVD) and related conditions that are associated with CVD, which show an improvement over hydroxytyrosol treatment alone.
Description of Related Art
[002] The statistics for CVD indicated that in the US, CVD is the major cause of death. The economic cost of CVD related deaths and conditions are enormous. Atherosclerosis and metabolic syndrome are among the many causes of CVD, and the arterial presence of plaque deposits, high levels of low density lipoproteins (LDL), and the like, are associated with such conditions. Accordingly, hypertension, high levels of triglycerides, and high total cholesterol in the blood are contributing factors in the development of CVD. Preventing the start of these factors or reducing existing plaque and cholesterol are key to the treatment and prevention of cardiovascular disease.
[003] It has been shown that hydroxytyrosol extracts which contain a high percentage of hydroxytyrosol can both treat and prevent CVD to some extent better than olive oils and other products containing a lower percentage of hydroxytyrosol. It is not a perfect solution, and, therefore, there needs to be products that treat CVD, reduce plaque buildup, and lower LDL blood levels.
BRIEF SUMMARY OF THE INVENTION
[004] The present invention results from the discovery that a number of products, in combination with a 10% or higher hydroxytyrosol composition, improve the prevention and treatment of CVD, cystic fibrosis (and related conditions) in a human subject in need of such treatment, as compared to treatment with hydroxytyrosol without the added compositions.
[005] Accordingly, in one embodiment, the present invention relates to an improved method of treating or preventing a cardiovascular disease, cystic fibrosis, or related condition in an individual, comprising administering to the individual a therapeutically effective amount of a composition comprising at least 10% hydroxytyrosol and at least one of a composition selected from the list consisting of:
a) vitamin A;
b) vitamin B; c) vitamin C;
d) vitamin D;
e) vitamin E;
f) omega-3;
g) glucosamine;
h) chondroitin;
i) an anti-inflammatory;
j) CoQ10; and
k) Ezetimibe.
[006] In yet another embodiment, it relates to a composition for treating or preventing a cardiovascular disease, cystic fibrosis, or related condition in an individual comprising a therapeutically effective amount of a composition containing at least 10% hydroxytyrosol w/w and at least one of a composition selected from the list consisting of:
a) vitamin A;
b) vitamin B;
c) vitamin C;
d) vitamin D;
e) vitamin E;
f) omega-3;
g) glucosamine;
h) chondroitin;
i) an anti-inflammatory;
j) CoQ10; and
k) Ezetimibe. DETAILED DESCRIPTION OF THE INVENTION
[007] While this invention is susceptible to embodiment in many different forms, there will herein be described in detail specific embodiments, with the understanding that the present disclosure of such embodiments is to be considered as an example of the principles and not intended to limit the invention to the specific embodiments shown and described. This detailed description defines the meaning of the terms used herein and specifically describes embodiments in order for those skilled in the art to practice the invention.
DEFINITIONS
[008] The terms "about" and "essentially" mean ±10 percent.
[009] The terms "a" or "an", as used herein, are defined as one or as more than one. The term "plurality", as used herein, is defined as two or as more than two. The term "another", as used herein, is defined as at least a second or more. The terms "including" and/or "having", as used herein, are defined as comprising (i.e., open language). The term "coupled", as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.
[010] The term "comprising" is not intended to limit inventions to only claiming the present invention with such comprising language. Any invention using the term comprising could be separated into one or more claims using "consisting" or "consisting of claim language and is so intended.
[011 ] References throughout this document to "one embodiment", "certain embodiments", and "an embodiment" or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.
[012] The term "or" as used herein is to be interpreted as an inclusive or meaning any one or any combination. Therefore, "A, B or C" means any of the following: "A; B; C; A and B; A and C; B and C; A, B and C". An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive.
[013] The term "means" preceding a present participle of an operation indicates a desired function for which there is one or more embodiments, i.e., one or more methods, devices, or apparatuses for achieving the desired function, and that one skilled in the art could select from these or their equivalent in view of the disclosure herein and use of the term "means" is not intended to be limiting.
[014] As used herein, the term "cardiovascular disease", or CVD, refers to plaque buildup in the arteries. It occurs when fat, cholesterol, and other substances build up on the walls of arteries and form hard substances called plaque. Plaque builds up in the arteries, and frequently this condition is called atherosclerosis. Eventually, the plaque deposits can make the artery narrow and less flexible. This increases resistance to blood flow. If the artery becomes too narrow, blood flow to the heart can slow down or stop, which causes chest pain, shortness of breath, heart attacks, as well as other serious symptoms. Even further, plaque can break apart from its original location and move through the bloodstream. It can block other locations and this is frequently the cause of heart attacks. In addition, blood clots can form around the plaque and, if a clot moves into the heart, lungs, or brain, it can cause a stroke, heart attack, or pulmonary embolism. Cystic fibrosis affects the cells that produce mucus, sweat, and digestive liquids. It causes these fluids to become thick and sticky, causing damage to the lungs and digestive system.
[015] As used herein, the term "related condition" refers to the process of arterial plaque buildup, increasing cholesterol, increasing low density lipoproteins (LDL) and the like, associated with the final deposition of plaque in the arteries. It also relates to related mucus problems associated with cystic fibrosis. By treating an individual, one can prevent these conditions from developing into CVD or, if already in a CVD condition, treating it by reversing these related conditions.
[016] As used herein, the term "individual" refers to a human person either suffering from CVD or cystic fibrosis, or in danger of suffering from CVD or cystic fibrosis.
[017] As used herein, the term "composition" refers to a nutritional composition of olive oil that has been extracted to isolate and concentrate the hydroxy tyrosol in the olive oil to a concentration of 10% or more. In one embodiment, it is present from about 10% to less than 20%. This can be done by a number of methods. As an example, an olive oil hydroxytyrosol fortified oil can be made based on the teaching of EP 2170090 or as taught in US application 14/002,920 (filed on November 4, 2013).
[018] As used herein, the term "at least one of an effective amount" refers to an addition of a composition that is synergistic or enhances the effect of the
hydroxytyrosol in treating or preventing CVD, cystic fibrosis, or a related condition. This includes the vitamins A, B, C, D, E, omega-3, glucosamine, chondroitin, and anti-inflammatohes, such as aspirin, acetaminophen, turmeric, salicin containing compositions (such as willow bark, CoQ10, or Ezetimibe) and the like.
[019] These additional compositions are incorporated into the olive oil extract. They can be done by means known in the art, including mixing, emulsification, dissolution and the like. One of skill in the art will be able to determine the proper amounts for the individual based on size, age, and the like, and be able to determine methods for incorporation of the extra items into the olive oil. The administration of the olive oil, then, is also by the same route as compositions designed to deliver hydroxytyrosol alone.
[020] As used herein, the term "therapeutically effective amount" refers to an amount of both the hydroxytyrosol and the at least one composition sufficient to treat or prevent symptoms or conditions of cardiovascular disease or related conditions, in an individual to a measurably greater extent than is known for hydroxytyrosol alone.
[021 ] Those skilled in the art to which the present invention pertains may make modifications resulting in other embodiments employing principles of the present invention without departing from its spirit or characteristics, particularly upon considering the foregoing teachings. Accordingly, the described embodiments are to be considered in all respects only as illustrative, and not restrictive, and the scope of the present invention is, therefore, indicated by the appended claims rather than by the foregoing description or drawings. Consequently, while the present invention has been described with reference to particular embodiments, modifications of structure, sequence, materials and the like apparent to those skilled in the art still fall within the scope of the invention as claimed by the applicant.

Claims

What is claimed is:
1 . An improved method of treating or preventing a cardiovascular disease or related condition in an individual comprising administering to the individual a therapeutically effective amount of a composition comprising at least 10% hydroxytyrosol and at least one of a composition selected from the list consisting of:
a) vitamin A;
b) vitamin B;
c) vitamin C;
d) vitamin D;
e) vitamin E;
f) omega-3;
g) glucosamine;
h) chondroitin;
i) an anti-inflammatory
j) CoQ10; and
k) Ezetimibe.
2. A method according to Claim 1 wherein the anti-inflammatory is selected from the group consisting of salicin containing compositions, aspirin,
acetaminophen and turmeric.
3. A method according to claim 1 wherein the composition includes
hydroxytyrosol extracted from olive oil.
4. A method according to claim 1 wherein the related condition is selected from the group consisting of arterial plaque buildup and elevated blood LDL.
5. A composition for treating or preventing a cardiovascular disease or related condition in an individual comprising a therapeutically effective amount of a composition containing at least 10% hydroxytyrosol w/w and at least one of a composition selected from the list consisting of:
a) vitamin A;
b) vitamin B;
c) vitamin C;
d) vitamin D;
e) vitamin E;
f) omega-3;
g) glucosamine;
h) chondroitin;
i) an anti-inflammatory
j) CoQ10; and
k) Ezetimibe.
6. The composition according to Claim 5 wherein the anti-inflammatory is
selected from the group consisting of salicin containing compositions, aspirin, acetaminophen and turmeric.
7. The composition according to claim 5 wherein the composition includes
hydroxytyrosol extracted from olive oil.
8. The composition according to claim 5 wherein the hydroxytyrosol is present from about 10% to less than 20% w/w of the composition.
PCT/US2017/030566 2016-05-03 2017-05-02 Method of treating cardiovascular disease and cystic fibrosis with combination product containing hydroxytyrosol WO2017192535A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662331031P 2016-05-03 2016-05-03
US62/331,031 2016-05-03

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WO2017192535A1 true WO2017192535A1 (en) 2017-11-09
WO2017192535A8 WO2017192535A8 (en) 2017-12-28

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100184868A1 (en) * 2007-07-23 2010-07-22 Lopes Mas Jose A Fortification of nutritional products with olive extracts containing hydroxytyrosol and hydroxytyrosol fortified nutritional products.
WO2015193630A1 (en) * 2014-06-18 2015-12-23 Evolva Sa Treatment of cardiovascular risk in patients with cardiovascular disease and/or diabetes

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100184868A1 (en) * 2007-07-23 2010-07-22 Lopes Mas Jose A Fortification of nutritional products with olive extracts containing hydroxytyrosol and hydroxytyrosol fortified nutritional products.
US20130309300A1 (en) * 2007-07-23 2013-11-21 Probelte Pharma S.A. Fortification of nutritional products with olive extracts containing hydroxytyrosol and hydroxytyrosol fortified nutritional products
WO2015193630A1 (en) * 2014-06-18 2015-12-23 Evolva Sa Treatment of cardiovascular risk in patients with cardiovascular disease and/or diabetes

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