NZ225527A

NZ225527A - Nutrient mixture containing calcium, fluorine, vitamin d, folic acid and zinc

Info

Publication number: NZ225527A
Application number: NZ225527A
Authority: NZ
Inventors: Patrick Darmenton
Original assignee: Synthelabo
Priority date: 1987-07-23
Filing date: 1988-07-22
Publication date: 1990-11-27
Also published as: JPS6467164A; FR2618305A1; PT88085B; NO883264L; NO883264D0; CA1336867C; ATE66784T1; AU604347B2; EP0300895B1; AU1971888A; KR890001462A; DK413888D0; DK413888A; FR2618305B1; EP0300895A1; DE3864621D1; PT88085A; ZA885372B

Abstract

Polymeric, complete food mixture in the form of a fine emulsion, intended for oral or enteral feeding of the elderly, which mixture contains . calcium (> 0.066 g/100 ml) in combination with fluorine (0.05 to 0.25 mg/100 ml) and vitamin D (60 to 110 IU/100 ml), . folic acid (0.13 to 0.4 mg/100 ml), and . zinc (2 to 4.0 mg/100 ml).

Description

<div id="description" class="application article clearfix"> New Zealand Paient Spedficaiion for Paient Number £25527 •>»i * i * ■Uk-r ge pdt: '■W % , •;*-f O i '■',.j dD No.: Date: NO DRA\ Priority Datejsy: ... fr^'.T? ."^7 T Complete Specification Fiiedi^r.C Class: fS?&I .Sp,^,; Publication Date: ?! 7. .HPX.!??? P.O. Journal. No: ... NEW ZEALAND PATENTS ACT. 1953 22 5 5 2 7 COMPLETE SPECIFICATION NUTRIENT MIXTURE INTENDED FOR THE ELDERLY >y\Ve, SYNTHELABO, a French body corporate, of 58, Rue de la Glaciere, F-75013 Paris, France, hereby declare the invention for which "£</ we pray that a patent may be granted to meius, and the method by which it is to be performed, to be particularly described in and by the following statement:- - 1 - (followed by page la) 22 5 5 2 - 1 a- frUTRIENT MIXTURE INTENDED FOR THE ELDERLY The present invention relates to a nutrient mixture suitable for the elderly. Fifty to sixty per cent of hospitalised old people are undernourished (A. ROMAGNOLI - JULLARD et al. - 1984; A. 5 DEVILLE CHABROLE - 1986), and their lipid intake is very often unbalanced. Prolonged confinement of old people to bed leads to increased morbidity. Moreover, ageing of the population is a well known 10 phenomenon in European countries and in the United States. Ageing leads to substantial physiological changes, capable of affecting the requirements for certain nutrients, vitamins or minerals. At the present time, there is no complete specific 15 product for old people. The present invention provides a polymeric complete nutrient mixture, in the form of a fine emulsion, suitable for use as an oral or enteral foodstuff for the elderly, which mixture comprises, per 100 ml of mixture, greater 20 than 0.066 g calcium, 0.05 to 0.25 mg fluorine, 60 to 110 IU vitamin D, 0.13 to 0.4 mg folic acid and 2 to 4.0 mg zinc. The nutrient mixture of the invention is a ready-to-use, polymeric complete preparation, in the form of a fine 25 emulsion generally having a particle size of from 300 to 400nm. 2 5 5 2 7 - 2 - Preferably the nutrient mixture comprises lipids such that the lipid intake provided 1) contains eicosapentaenoic C20:5, (n-3) (0.25 to 75% of lipid intake), and 2) fulfils the following criteria EFA Essential fatty acids - 0.4 to 1.0 EFA Saturated fatty acids EFA (n-6) series fatty acids - 3.5 to 10.0 EFA (n-3) series fatty acids. The nutrient mixture may also comprise 2 to 8 mg niacin and 10 to 16.7 jug chromium per 100 ml of mixture. It may also comprise a protein source containing 0.66 to 1.07 g ar^inine per 100 ml of mixture. Administered by tube or orally, the nutrient mixture is specifically adapted to the nutrient requirements of the elderly, since it takes account of the protein, lipid, vitamin, mineral and trace element, etc., requirements specific to the elderly, and of intestinal absorption, and since it enables old people to be fed while averting complications due to stress. The choice of the constituents of the nutrient * 22 5 527 r> o 3 - mixture of the invention is directed towards several objectives. 1. To correct the nitrogen balance. The nitrogen balance is defective in elderly sub- 5 jects; this deficiency is aggravated by a stress situation. The calorie/nitrogen intake must be sufficient to provide for a favourable outcome. 2. To facilitate healing phenomena. The restoration of a good protein intake pre- and -10 postoperatively promotes healing. However, a deficiency in folates leads to a delay in healing. The nutrient mixture of the invention contains proteins in a quantity ranging from 10 to 16 g per day, 15 and folic acid according to a daily intake of between 2 and 7 mg. Moreover, it has proved useful that, in some cases, there should be arginine among the proteins. 3. To provide for a good lipid intake, especially 20 of linoleic and eicosapentaenoic acids. To this end, the nutrient mixture of the invention contains a mixture of 2 or 3 vegetable oils and a fish oil, this mixture providing the requisite amounts of fatty acids. The lipid intake provided by the emulsion 25 of the invention advantageously has a ratio between the sum of the essential fatty acids and the sum of the saturated fatty acids ranging from 0.4 to 1.0, and by a ratio 22 5 5 2 7 between the sum of the n-6 fatty acids and the sura of the n-3 fatty acids ranging from 3.5 to 10.0, so as to supply substantial amounts of linoleic and eicosapentaenoic acids. The nutrient mixture of the invention also con-5 tains MCT (medium-chain triglycerides) (20 to 30% of the lipid intake provided), to supply the elderly with a lipid source which can be very rapidly absorbed intestinally and whose penetration into mitochondria does not require carni t ine. 10 4. To normalize the glucose tolerance. The elderly react more slowly to carbohydrate overload, as may be shown in the induced hyperglycemia test. Thus, the nutrient mixture of the invention generally contains chran-ium (150 to 250 ug), which potentiates the peripheral 15 action of insulin, and niacin (30 - 120 mg), which reinforces the action of the added trace element. 5. To increase the immune defences. Among the different factors which affect the immune defences, zinc performs a fundamental role. The nut-20 rient mixture of the invention contains from 2 to 4 mg of zinc per 100 ml of emulsion. It also contains other constituents which are involved to various extents: vitamin A (daily intake provided: 4000 to 6000 IU), vitamin Bwhich affects cel-25 lular immunity (daily intake provided: 10 to 20 mg). 6. To combat decalcification. The calcium losses, of hormonal origin, which - 5 - 225527 affect the elderly are responsible for 50,000 fractures per annum and for 1,000,000 vertebral compressions, mainly in women. The nutrient mixture of the invention contains 5 calcium at a level greater than 1 g/day, vitamin D at a level of between 1000 and 2200 IU/day, fluorine at a level of between 1 and 5 mg/day. Moreover, the MCT present 'in the lipid intake pro-10 vided, at a level of 20 to 30X, appear to promote the absorption of calcium, amino acids and magnesium (A.C. BACH - V.K. BABAYAN - 1982). 7. To decrease oxidation phenomenona. Among the causes of ageing, one of the hypotheses 15 put forward is that of "free radicals". It has been demonstrated that the level of survival rises in animals whose feed has been enriched with antioxidants. In addition, a state of stress in a patient is characterized by the appearance of free radicals, whose 20 presence is not desirable, especially if the patient is fed with unsaturated lipids (KIY0SHI TAKEDA et al. -1984-1986). The nutrient mixture of the invention contains a Iipid-soluble antioxidant: vitamin E (30 to 25 150 mg/day) a water-soluble antioxidant: vitamin C (150 to 300 mg/day) 225527 selenium (40 - 150 pg/day). This trace element is the cofactor of glutathione oxidase, whose role is to reduce peroxides (J.L. ROMBEAU - 1984). 8. To facilitate intestinal transit. Old people very often exhibit "sluggishness of the digestive system", which must be combated. The presence of fibres in the emulsion contributes to this; it is desirable in the form of a daily intake of 3 to 12 grammes. The non-limiting examples which follow illustrate the invention. E x amp Ie 1; A Proteins: B Lipids: Daily intake p rov i ded 84 to 97 g 68 to 76 g composition: MCT 20 X borage oil 7. 7% European olive oil 45. 0% soybean oil 19. 5X codliver oil 7. 8X C Carbohydrates: hydrolysate of polyoses still containing 60 to 80% of polysaccharides. D Vitamins: A (IU) 240 to 265 g 4000 to 6000 «' ,*. V.y^Tntri' ■•>* v^, wa^j, T/ «-,-j - 7 - 22 5 5 2 7 B1 (mg) 3 to ! 5 B2 (mg) 3 to 6 ®6 (mg) 10 to 20 B12 (ug> 5 to 25 5 C (mg) 150 to 300 D (IU) 1200 to 2200 E (mg) 30 to 150 NIACIN (mg) 30 to 120 Folic acid (mg) 2 to 6 10 Pantothenic acid (mg) 10 to 35 BIOTIN (ug> 180 to 260 E Minerals: Na (mg) 1875 to 2250 K (mg) 900 to 2250 15 Ca (mg) 1200 to 3000 P (mg) 1000 to 2000 Mg (mg) 450 to 900 Fe (mg) 16 to 30 Zn (mg) 40 to 60 20 CI (mg) 1000 to 5100 F Trace elements: I (ug) 120 to 200 Mn (mg) 2.5 to 5 Cu (mg) 2.5 to 5 25 Cr <ug> 150 to 250 Mo (ng> 275 to 350 F (mg) 1 to 5 - 8 - 225527 Se (jjg) 40 to 150 G Miscellaneous . L-carnitine (mg) 200 to 500 . emulsifier: soybean lecithin (g) 1.33 - 26.6 5 . fibres (from sugarbeet) (g) (opt ional) 3-12 . flavouring (such as vanilla, mocha, strawberry or chocolate) . NaOH or HCl solution to adjust the pH 10 . water (ml) qs 2000 ZESSENTIAL FA = 0.74 Z F A (n-6) = 8.8 LSATURATED FA EFA (n-3) Example 2 A, C, D and E identical to Example 1 15 B Lipids: Composition: MCT 20 % borage oil 15.3% European olive oil 45.2% walnutoil 15.1% 20 sardine oil 4.4% ZESSENTIAL FA = 0.76 ZFA (n-6) = 5.30 ZSATURATED FA ZFA (n-3) Example 3 A, C, D and E identical to Example 1 25 B Lipids: Composition: MCT 20 % borage oil 4 % - i^i.»^rt«!«W>f,!W«!<'A'-«''' • ■.*, .w — - i 225521 - 9 - European olive oil 56.5% soybean oil 11.8% codli ve r o i I 7.7% ZESSENTIAL FA = 0.53 ZFA (n-6) = 5.5 5 ZSATURATED FA ZFA (n-3) Example 4: A, C, D and E identical to Example B Lipids: Compos i t i on: MCT 20 X 10 borage oil 15.3% European olive oil 42.8% walnut oiI 14.0% codliver oil 7.9% ZESSENTIAL FA = 0.75 ZFA (n-6) 15 ZSATURATED FA ZFA (n-3) Example 5: A, C, D and E identical to Example B Lipids: Composition: MCT 20 % 20 borage oil 15.3% European olive oil 40.31% walnut oiI 13.0% herring oi I 11.4% ZESSENTIAL FA = 0.71 ZFA (n-6) 25 ZSATURATED FA ZFA (n-3) Example 6: A, C, D and E identical to Example 68 to 76 g - 10 - 22 5 5 2 7 B Lipids: 68 to 76 g 15 Compos i t ion: MCT 20 % borage oil 15.3% European olive oil 34.6% soybean o i I 18.7% herring o i I 11.4% ZESSENTIAL FA = 0.74 ZFA (n-6) ZSATURATED FA ZFA (n-3) Example 7: A, C, D and E identical to Example B Lipids : Compos i t ion: MCT 30 % borage oil 15.3% codliver o i I 2.4% rapeseed o i I 47.2% ZESSENTIAL FA = 0.67 ZFA (n-6) ZSATURATED FA ZFA (n-3) Example 8: 68 to 76 g A, C, 0 and E identicaL to Example 1 20 B Lipids: 68 to 76 g Composition: MCT 30 % borage oil 20.4% herringoil 3.5% lupin oil (1) or 25 rapeseed oil (2) 46.1% (1) ZESSENTIAL FA = 0.56 ZFA (n-6) = 4.53 ZSATURATED FA ZFA (n-3) t*''ri"i'*' ^'isOt1' '■'• ' L11 ?w-' • <$-?■ .v-f; I 22 5 5 2 7 - li - ■I J '\ - % ■■' I o (2) ZESSENTIAL FA = 0.66 /~"N £ X ! i £*\ | W ? 10 ZSATURATED FA Example 9: A, C, D and E identical to Example 1 B Lipids: Composition: MCT 30 X borage oil 20.42 sardine oil 1.4% lupin oil (1) or rapeseed oil (2) 48.2X (1) ZESSENTIAL FA = 0.57 ZFA (n-6) = 4.81 ZFA (n-3) 68 to 76 g ZSATURATED FA (2) ZESSENTIAL FA = 0.67 ZFA (n-6) = 4.42 ZFA (n-3) ZFA (n-6) = 4.70 ZFA (n-3) ZSATURATED FA 15 Example 10: A, C, D and E identical to Example 1 B Lipids: Composition: MCT 30 X blackcurrent oil 17.6% 20 herring oil 3.5% groundnut oil (1) ) or safflower oil (2) ) 48.9% or European olive oil (3) or American palm oil (4) 68 to 76 4; ■Sit ri-Cd »• V .-'iVr nT -iI-"*'1- - ••' *• "-v,i *>• - 12 - 22 5 5 27 1X*-~-v ZESSENTIAL FA = (1) 0.59 ZSATURATED FA (2) 0.68 (3) 0.46 (4) 0.56 Example 11: ZFA (n-6) = (1) 6.75 ZFA (n-3) (2) 6.67 (3) 4.22 (4) 5.69 ZFA (n-3) A, C, D and E identical to Example 1 B Lipids: Composition: MCT 30 % blackcurrant oil 17.6% 10 codliver oil 2.4% s af fI owe r o iI (1) ) or hazelnut oil (2) ) 49.9% or ol ive oiI (3) or American palm oil (4) 15 ZESSENTIAL FA = (1) 0.69 ZSATURATED FA (2) 0.64 (3) 0.53 (4) 0.57 Example 12: 20 A, C, D and E identical to Example 1 B Lipids: Composition: MCT 30 % blackcurrantoil 17.6% sardine oil 1.4% 25 safflower oil (1) ) or African olive oil (2) ) 50.9% or American palm oil (3) 68 to 76 g ZFA (n-6) = (1) 6.76 (2) 5.95 (3) 5.33 (4) 5.74 68 to 76 g </div>

Claims

<div id="claims" class="application article clearfix printTableText"> ., _ x :^^,^^.w^"V-'-"" *4' l^y, , & 'W 5 W 22 5 5 2 7 o e; j»**'>*V. o - 13 - ZESSENTIAL FA = (1) 0.70 ZFA (n-6) = (1) 6.81 ZSATURATED FA (2) 0.53 ZFA (n-3) (2) 4.76 (3) 0.57 (3) 5.77 -j-w O 225527 - 14 - WHAT WE CLAIM IS:

1. A polymeric complete nutrient mixture, in the form of a fine emulsion, for use as an oral or enteral foodstuff for the elderly, which mixture comprises, per 100 ml of mixture, greater than 0.066 g calcium, 0.05 5 to 0.25 mg fluorine, 60 to 110 IU vitamin D, 0.13 to 0.4 mg folic acid and 2 to 4.0 mg zinc.

2. A nutrient mixture according to claim 1 which comprises lipids which 1) contain eicosapentaenoic acid C20:5, (n-3), 10 and 2) fulfil . the following criteria ZFA Essential fatty acids - 0.4 to 1.0 IFA Saturated fatty acids ZFA (n-6) series fatty acids - 3.5 to 10.0 15 I FA (n-3) series fatty acids

3. A nutrient mixture according to claim 1 or 2 which comprises 2 to 8 mg niacin and 10 to 16.7 fjq chromium per 100ml of the mixture.

4. A nutrient mixture according to any one of claims 20 1 to 3 which comprises a protein source containing 0.66 to 1.07 g arginine Per luuml of the mixture.

5. A nutrient mixture substantially as described in </div>