WO1994025042A1 - Procede de traitement de l'arteriosclerose avec du psyllium - Google Patents

Procede de traitement de l'arteriosclerose avec du psyllium Download PDF

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Publication number
WO1994025042A1
WO1994025042A1 PCT/US1994/004756 US9404756W WO9425042A1 WO 1994025042 A1 WO1994025042 A1 WO 1994025042A1 US 9404756 W US9404756 W US 9404756W WO 9425042 A1 WO9425042 A1 WO 9425042A1
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WO
WIPO (PCT)
Prior art keywords
psyllium
foodstuff
grams
atherosclerosis
cholesterol
Prior art date
Application number
PCT/US1994/004756
Other languages
English (en)
Inventor
Shirley Chen
Victor Fulgoni
Original Assignee
Kellogg Company
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 Kellogg Company filed Critical Kellogg Company
Priority to AU67786/94A priority Critical patent/AU668045B2/en
Publication of WO1994025042A1 publication Critical patent/WO1994025042A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/238—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin from seeds, e.g. locust bean gum or guar gum
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L7/00—Cereal-derived products; Malt products; Preparation or treatment thereof
    • A23L7/10—Cereal-derived products
    • A23L7/115—Cereal fibre products, e.g. bran, husk
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L7/00—Cereal-derived products; Malt products; Preparation or treatment thereof
    • A23L7/10—Cereal-derived products
    • A23L7/117—Flakes or other shapes of ready-to-eat type; Semi-finished or partly-finished products therefor
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L7/00—Cereal-derived products; Malt products; Preparation or treatment thereof
    • A23L7/10—Cereal-derived products
    • A23L7/117—Flakes or other shapes of ready-to-eat type; Semi-finished or partly-finished products therefor
    • A23L7/135—Individual or non-extruded flakes, granules or shapes having similar size, e.g. breakfast cereals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • This invention relates to prevention and treatment of atherosclerosis. More particularly, it relates to prevention and treatment of atherosclerosis by administration of psyllium to a subject.
  • Atherosclerosis is a form of arteriosclerosis characterized by the accumulation of irregularly distributed lipid deposits in the intima of large and medium sized arteries. These deposits are associated with arterial fibrosis and calcification. Severe atherosclerosis leads to reduction of the arterial lumen, and a predisposition to thrombosis. Ischemic manifestations include angina pectoris, myocardial infarction, strokes, intermediate claudication and, in some cases, gangrene of the lower extremities.
  • Another, more aggressive approach has been the treatment of the risk factor with antihyperlipidemic, and/or anti- hypercholesterolemic drugs in addition to dietary management.
  • These drugs include various heterocyclic compounds, such as indole derivatives (U.S. Patent No. 5,195,446); iminocarbonyl derivatives (U.S. Patent Nos. 5,189,058 and 5,185,358), mevalonolactones (U.S. Patent No. 5,185,328), and so forth.
  • Other approaches address the enzymatic mechanisms by which complex lipids and cholesterol esters are manufactured and/or metabolized, seeking to modify these mechanisms in a way that reduces the serum levels of cholesterol or other lipids.
  • psyllium A natural product which has become known for its cholesterol lowering efficacy is psyllium. This material is a mucilaginous substance, derived from the seeds of the Plantago genus. Initially, psyllium was used extensively in bulk laxatives. Eventually, it was employed in foodstuffs, as it was associated with digestion regulating properties, satiation, and "fullness feeling", as is noted in, e.g., U.S. Patent Nos. 3,574,634 and 4,348,379.
  • U.S. Patent No. 3,148,114 The earliest suggestions of psyllium's usefulness as a cholesterol lowering agent may be found in U.S. Patent No. 3,148,114. This reference suggests that ground husks of whole psyllium (Plantago psyllium) may be used to lower blood cholesterol.
  • U.S. Patent No. 4,849,222 discloses a medicinal composition containing psyllium seed gum, and nonabsorbable, nondigestible polyol polyester as an agent for lowering blood cholesterol levels.
  • Other examples of the patent literature which disclose medicinal type compositions which contain psyllium include Colliopoulos et al., U.S. Patent No. 4,459,280; Day et al., U.S. Patent No.
  • psyllium containing compositions are useful as bulking agents and/or laxatives, as well as for reducing blood or serum cholesterol levels.
  • psyllium there are no teachings in the references of the use of psyllium to prevent or to treat atherosclerosis. Indeed, one cannot generalize from a serum cholesterol lowering effect to anti-atherosclerotic efficacy.
  • Atherosclerosis can be prevented and treated by administering psyllium to a subject in need of such treatment.
  • the manner in which the psyllium is administered is preferably in the form of a foodstuff, although this is not required.
  • the experimental model used in all of the experiments described herein is the "susceptible to experimental atherosclerosis" or "SEA" Japanese quail.
  • Subject animals were randomized into seven treatment groups, caged individually. The birds were acclimated for one week prior to the experimental period by being fed "diet 1" as described in Table 1, which follows. During this period of time, as well as throughout the experiments, the birds were given free access to food and water.
  • Each group received a different diet, as described in Table 1. These diets were designed to be nearly nutritionally identical, save for the presence or absence of dietary cholesterol and the source of dietary fiber. Each diet included 10% dietary fiber. The diets were fed to the quail for eight weeks.
  • Psyllium was administered either as a ready-to-eat cereal, the recipe for which is given in Serial Nos. 817,244 and 819,569, now U.S. Patent Nos. , and
  • untreated psyllium samples from two different batches were used, referred to as "Psyllium 1" and "Psyllium 2", respectively.
  • the recipe for the cereal is provided in Example 3, which follows. When the cereal was used, it was ground and mixed with the other dietary components.
  • cellulose without added cholesterol acts as a negative control.
  • Cellulose is a highly purified source of dietary fiber, does not contain soluble dietary fiber, and does not reduce blood cholesterol.
  • the cellulose diet augmented with dietary cholesterol acts as another control, demonstrating the hypercholesterolemic effect of a diet including cholesterol but no soluble fiber.
  • Each bird was weighed at the beginning of the study, and at two week intervals thereafter. Pre-weighed portions of diet were provided weekly, and food remaining at the end of every two weeks was measured, so that the total amount of food consumed could be determined.
  • the sampled serum was tested to determine total cholesterol. This was done using an enzymatic cholesterol reagent (Sigma), within 24 hours of sampling, on 5 ul samples prepared as follows.
  • High density lipoprotein (HDL) cholesterol was measured by diluting 10 ul of serum with 500 ul distilled water, followed by addition with mixing of 20 ul of 0.5 M CaCl 2 and 50 ul of 1% bovine lung heparin. After setting at refrigerator temperature overnight, HDL cholesterol was measured in the clear supernatant procured after centrifugation. The sum of very low density lipoprotein (VLDL) cholesterol and low density lipoprotein (LDL) cholesterol was determined by subtracting the HDL values from total serum cholesterol levels.
  • VLDL very low density lipoprotein
  • LDL low density lipoprotein
  • the arteries were blotted, weighed, and finely ground in a glass tissue homogenizer with isopropanol.
  • Tissue (arterial) cholesterol was extracted from the homogenate by mixing overnight at room temperature. Cholesterol analyses were carried out, using the same enzymatic reagent described supra. Results were calculated as milligrams cholesterol per gram of arterial tissue on a wet weight basis.
  • Tables 2 and 3 summarize the results of these experiments. The studies on atherosclerotic plaque formation, and arterial cholesterol concentrations (Table 2) are discussed first.
  • Psyllium-containing intermediate nuggets were prepared having a final composition on a dry weight basis as set forth in Table 4 below.
  • the psyllium husks had been sterilized by extrusion. All of the ingredients were first mixed and then directly expanded using an extruder. The product exit temperature from the extruder was 190°F and the moisture content after cooling was 31%. The product was then dried for 30 minutes at 210°F to a moisture content of 3%. The nuggets were then combined in the following cereal. Table 5
  • Vitamin B3 0.01828
  • Vitamin B2 0.00155
  • Vitamin A & D cone 3% BHT 0.02285 Vitamin B6 0.00234 Vitamin B1 0.00137 Vitamin B12
  • the bulk ingredients were first mixed.
  • the flavoring ingredients comprising sugar, salt, color, HFCS and malt syrup (previously diluted with warm water) were then added to and mixed with the bulk ingredients in a rotating cooker.
  • the bulk ingredients were cooked for 65 minutes at 17 psi, cooled and screen separated.
  • psyllium-containing intermediate nuggets having a composition as set forth in Table 4 above, and prepared as described, were blended with the bran, and the mixture cooked to completion in a mixer.
  • the mixture was then milled, pelletized, and the pellets dried to a moisture content of about 20%.
  • the product was tempered hot for 30 minutes, flaked and toasted at 370°F.
  • the flakers were then sprayed with the coating composition together with Vitamins A and D, B6, B12 and Bl.
  • the finished flakes had a food moisture content of about 3%.
  • the foregoing examples describe a method for preventing, reducing or treating atherosclerosis in a subject.
  • the method simply stated, involves administering to a subject in need thereof an amount of psyllium sufficient to prevent or reduce atherosclerosis.
  • the subject of interest is preferably a human, typically a human particularly susceptible to development of atherosclerosis.
  • Such individuals are easily identified from the population at large via a number of parameters, including prior incidence of the pathological condition, family history showing predilection for the disease, a high risk lifestyle, and so forth.
  • the invention also embraces preventing recurrence of atherosclerosis, also by consumption of psyllium.
  • the psyllium may be administered in a number of ways.
  • the survey of the art in this field indicates that while psyllium may be administered "as is", it is unpleasant in this form. Indeed, it is far more preferable to administer the psyllium in the form of a foodstuff, such as those described in the art.
  • Farinaceous products are particularly preferred, with ready to eat cereals being especially preferred.
  • Formulations which are described in, e.g.. Serial Nos. 817,244 and 819,569, now U.S. Patent Nos. , the disclosures of which are incorporated by reference are especially preferred psyllium-containing ready-to-eat cereals.
  • the manner of administration and amount of psyllium to be administered may vary, depending upon the subject in question. Generally, it is preferred that the psyllium be administered in an amount of about 3 grams per "serving", a “serving” referring to a full meal, snack, or other point at which food is consumed.
  • the psyllium may be spread over a number of different food items consumed in a meal, or in one food stuff. In a preferred embodiment, the foodstuff contains about 1.5g-6.0g of psyllium per ounce. It is especially preferred that the subject consume anywhere from about 3 grams to about 25 grams of psyllium daily. Most particularly preferred are regimes where the subject consumes from about 3 to about 12 grams of psyllium daily. These ranges, of course, must be treated as very general guidelines, as age, prior medical history, and other factors will determine how much psyllium should be consumed.
  • Preventing atherosclerosis refers both to avoiding any atherosclerosis “ab initio”, but also to prophylaxis in eliminating recurrence of the condition or aggravation thereof.
  • the method can be used in connection with other therapies, in addition to a therapeutic regime, such as drug based therapy, is completed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medical Informatics (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)

Abstract

L'invention concerne un procédé de prévention de l'artériosclérose par administration de psyllium à un sujet ayant besoin d'un tel traitement de prévention. Le psyllium est administré de préférence sous la forme d'un aliment farineux, tel que des céréales prêtes à consommer. L'invention décrit un traitement prophylactique de récurrence, ainsi qu'une prévention totale. Le procédé peut être utilisé seul ou en combinaison avec d'autres thérapies.
PCT/US1994/004756 1993-05-03 1994-05-02 Procede de traitement de l'arteriosclerose avec du psyllium WO1994025042A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU67786/94A AU668045B2 (en) 1993-05-03 1994-05-02 Method for treating atherosclerosis with psyllium

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5710893A 1993-05-03 1993-05-03
US08/057,108 1993-05-03

Publications (1)

Publication Number Publication Date
WO1994025042A1 true WO1994025042A1 (fr) 1994-11-10

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AU (1) AU668045B2 (fr)
WO (1) WO1994025042A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0725573A1 (fr) * 1993-09-17 1996-08-14 Kellogg Company Cereales pretes a consommer contenant du psyllium extrude, preimbibe
US7794745B2 (en) 2001-04-12 2010-09-14 Raisio Nutrition Ltd. Edible compositions for lowering cholesterol

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5244887A (en) * 1992-02-14 1993-09-14 Straub Carl D Stanols to reduce cholesterol absorption from foods and methods of preparation and use thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5244887A (en) * 1992-02-14 1993-09-14 Straub Carl D Stanols to reduce cholesterol absorption from foods and methods of preparation and use thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
AMRICAN JOURNAL OF CLINICAL NUTRITION, Volume 56, Number 2, issued August 1992, (USA), MCCALL et al., "Psyllium Husk l: Effect on Plasma Lipoproteins, Cholesterol Metabolism, and Atherosclerosis in African Green Monkeys", pages 376-384. *
DISSERTATION ABSTRACTS INTERNATIONAL, Vol. 47/06-B, issued 1986, MARK RANDOLF MCCALL, "The Effect of Psyllium Husk on Plasma Lipoproteins, Cholesterol Metabolism and Atherosclerosis in African Green Monkeys", Abstract No. AAD86-22006, page 2380. *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0725573A1 (fr) * 1993-09-17 1996-08-14 Kellogg Company Cereales pretes a consommer contenant du psyllium extrude, preimbibe
EP0725573A4 (fr) * 1993-09-17 1997-03-19 Kellog Co Cereales pretes a consommer contenant du psyllium extrude, preimbibe
US7794745B2 (en) 2001-04-12 2010-09-14 Raisio Nutrition Ltd. Edible compositions for lowering cholesterol
US8414913B2 (en) 2001-04-12 2013-04-09 Raisio Benecol Oy Edible compositions for lowering cholesterol

Also Published As

Publication number Publication date
AU6778694A (en) 1994-11-21
AU668045B2 (en) 1996-04-18

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