Classifications

• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23K—FODDER
  • A23K50/00—Feeding-stuffs specially adapted for particular animals
  • A23K50/40—Feeding-stuffs specially adapted for particular animals for carnivorous animals, e.g. cats or dogs
  • A23K50/48—Moist feed
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23K—FODDER
  • A23K20/00—Accessory food factors for animal feeding-stuffs
  • A23K20/10—Organic substances
  • A23K20/174—Vitamins
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23K—FODDER
  • A23K50/00—Feeding-stuffs specially adapted for particular animals
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23K—FODDER
  • A23K50/00—Feeding-stuffs specially adapted for particular animals
  • A23K50/40—Feeding-stuffs specially adapted for particular animals for carnivorous animals, e.g. cats or dogs
  • A23K50/42—Dry feed
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/15—Vitamins

Definitions

• the present invention relates to: a non-human diet or a non-human foodstuff comprising biotin at a concentration of at least 0.2mg/400kcal and/or one or more other B vitamins at a concentration of at least 33.0mg/400kcal; to a dietary supplement which, in addition to other nutrient intake supplies biotin at -a concentration of at least 0.2mg/400kcal and/or one or more B other vitamins at a concentration of at least 33.0mg/400kcal.
• the concentration of biotin and one or more other B vitamins is at least 33.2mg/400kcal.
• the present invention also relates to the use of a diet, a foodstuff or a supplement, according to the present invention for enhancing and/or improving the skin and coat condition of a non-human animal and to a process for the preparation of a diet, foodstuff or supplement according to the present invention.
• Biotin (a B vitamin, also known as vitamin H) serves as a cofactor for enzymes critical in metabolism. A deficiency of biotin can lead to impaired synthesis and metabolism of long chain fatty acids which are important in cutaneous integrity. Biotin supplementation has been shown to be useful in the treatment of certain clinical skin conditions in dogs (Frigg, M., Schulze, J. and Volker, L., Schewiz. Arch. Tier Helik. 131, 621-625, 1989). Deficiency in a number of other B vitamins manifests as dry scaly skin and a dry, brittle hair coat.
• the present invention provides, according to a first aspect, a non- human diet or non-human foodstuff comprising biotin at a concentration of at least 0.2mg/400 kcal and/or one or more other B vitamins at a concentration of at least 33.0mg/400kcal.
• biotin and one or more B vitamins are in combination they will comprise a total concentration of biotin plus other ' B vitamins of at least 33.2mg/400 kcal.
• concentrations per kcal are to kcal total metabolisable energy intake. The determination of calorie density can be identified using Nutritional Requirements of Dogs (1985) National Research Council (U.S.) National Academy Press Washington DC, ISBN: 0-309-03496-5 or
• a diet or foodstuff according to the present invention may include a "high-quality commercial food" .
• Such a food refers to a diet manufactured to produce the digestibility of the key nutrients of 80% or more, as set forth, for example, in the recommendations of the National Research Council (above). Similar nutrient standards may be used for other animals.
• a diet/foodstuff according to the first aspect has been shown to be effective in producing superior skin and coat condition in non-human animals.
• Supplementation of a food with a combination of higher than normal levels of biotin and/or one or more other B vitamin provides a) reduced skin scales (dander), b) increased coat softness, c) improvement in coat feel and d) reduced transepidermal water loss (that is, including improved skin barrier function).
• the invention comprises biotin and one or more B vitamins as described according to the invention.
• a “diet” can typically describe a range of foods eaten.
• a “foodstuff” can typically describe a substance used as a food.
• a “diet” or a “foodstuff” can include a supplemented diet or a supplemented foodstuff wherein a dietary supplement has been added to the diet or foodstuff.
• the present invention relates, for all aspects, to any non-human animal, in particular those with hair on the surface of the skin.
• Animals which have hair on the surface of the skin in an amount to form a substantial "coat” e.g. dogs, cats, horses, rabbits, guinea pigs, hamsters and other such animals may be most favourably effected by the present invention.
• the invention provides a dramatic improvement when the specified levels of biotin and one or more other B vitamin are used in combination.
• the first aspect of the invention is preferably used in combination with a complete and balanced food, for example, as described in National Research Council, 1985, Nutritional Requirements for Dogs, National Academy Press, Washington D.C. or Association of American Feed Control Officials, Official Publication 1996 and such as the complete balanced diet shown in the Examples.
• a complete and balanced pet food is a diet which meets all the nutritional requirements of the individual's lifestyle and life-stage.
• a complete and balanced food may contain biotin and/or other B vitamins. The levels present are included in the stated levels according to the invention.
• the first aspect of the invention applies preferentially to a non-human animal diet or foodstuff (preferably a commercial pet food) which is a wet (or moist), semi-moist (or semi-dry) or dry composition (food).
• a non-human animal diet or foodstuff preferably a commercial pet food
• the composition is a commercial pet food product.
• the invention relates to a domestic pet animal diet or foodstuff, especially for a dog or a cat.
• Wet food usually describes food which is sold in tins or foil containers or otherwise hermetically sealed packaging and has a moisture content of 70 to 90% .
• Dry food usually describes food which is of a similar composition, but with 5 to 15% moisture and often presented as small biscuit-like kibbles.
• compositions of such foods on a metabolisable energy basis include foods which are 13-100g/400kcal protein, 5-40g/400kcal fat, 0-100g/400kcal carbohydrate and 2-15g/400kcal ash.
• the diet or foodstuff is preferably packaged. In this way the consumer is able to identify, from the packaging, the ingredients in the food and confirm that it is suitable for the pet in question.
• the packaging may be metal (usually in the form of a tin or flexifoil), plastic, paper or card. The amount of moisture in any product may influence the type of packing which can be used or is required.
• the diet or foodstuff can be made according to any method known in the art, such as in Waltham Book of Dog and Cat Nutrition, Ed. ATB
• the concentrations of biotin and other B vitamins to be added to the diet/foodstuff are calculated on the basis of the energy content of the diet/foodstuff and of any additional nutrients which may be consumed by the animal.
• the diet or foodstuff according to the present invention encompasses any product which a pet animal, preferably a domestic dog or a domestic cat may consume in its diet.
• the invention covers standard food products, as well as pet food snacks
• the diet or foodstuff 4s preferably a cooked product. It may incorporate meat or animal derived material (such as beef, chicken, turkey, lamb, blood plasma, marrowbone etc, or two or more thereof).
• the diet or foodstuff alternatively may be meat free (preferably including a meat substitute such as soya, maize gluten or a soya product) in order to provide a protein source.
• the product may contain additional protein sources such as soya protein concentrate, milk proteins, gluten etc.
• the product may also contain a starch source such as one or more grains (e.g. wheat, corn, rice, oats, barley etc) or may be starch free.
• the product may comprise a gelatinised starch matrix.
• a typical dry commercial dog and cat food contains about 30% crude protein, about 10-20% fat and the remainder being carbohydrate, including dietary fibre and ash.
• a typical wet, or moist product contains (on a dry matter basis) about 40% fat, 50% protein and the remainder being fibre and ash.
• the present invention is particularly relevant for a diet or foodstuff as herein described which is sold as a diet or foodstuff for a pet animal.
• the biotin and one or more other B vitamin or two or more other B vitamins may be added to the diet or foodstuff together or separately.
• the biotin and/or other B vitamin(s) may be added at any time during the manufacture/processing of the diet/foodstuff, including at the end, as the last step before packaging.
• a B vitamin is any one of a group of water-soluble vitamins that, although not chemically related, are often found together, the same kind of food and all function as coenzymes.
• the B vitamins according to the present invention are not limiting.
• any recognised source of the vitamin including a provitamin or a substance with a similar effect (See, e.g., The Feeding Stuffs Regulations 1995, No 1412, Her Majesty's Stationery Office) is included according to the present invention. This relates to all B vitamins, including biotin.
• Preferred B vitamins according to the invention include:
• B vitamins For biotin; biotin itself, d-biotin or biotin dextran.
• Bl thiamin, aneurin, thiamin pyrophosphate, thiamin hydrochloride, thiamin monophosphate chloride; B2, riboflavin; B3, niacin, nicotinic acid, nicotinamide; B5, panthothenic acid, D-pantothenic acid, pathothenol; B6, pyridoxine hydrochloride, pyridoxol, pyridoxal phosphate; B12, cyanocobalamin, 5- deoxyadenosyl cobalamin: the B vitamins may be individual or in combinations of two or more thereof.
• B vitamins according to invention include one or more of Bl, BIO and B12.
• Preferred B vitamins for inclusion with biotin, according to the invention are; one or more of a B2, B3, B5 and B6 vitamin, in particular one or more of riboflavin, niacin, pantothenic acid and pyridoxine.
• the combined total of B vitamins other than biotin is at least 33mg/400kcal. This can comprise one or more different B vitamins.
• riboflavin Preferably these include riboflavin, niacin, pantothenic acid and pyridoxine.
• Preferred separate lower limits of riboflavin, niacin, pantothenic acid and pyridoxine are as follows: Riboflavin 4mg/400 kcal
• a preferred lower limit for a B12 vitamin is 0.025mg/400kcal.
• a preferred lower limit for a Bl vitamin is lmg/400kcal.
• a preferred lower limit for a BIO vitamin is 0.2mg/400kcal.
• a preferred embodiment of the invention is a diet or foodstuff with the lower limits of 0.2mg/400kcal biotin, 4mg/400kcal riboflavin, 20mg/400kcal niacin, 6mg/400kcal pantothenic acid and 3mg/400kcal pyridoxine, in combination.
• Preferred raised concentrations are as follows:
• Biotin 0.25mg/400kcal or above, more preferably lmg/400kcal or above Riboflavin: 5mg/400kcal or above, more preferably 5.9mg/400kcal or above Niacin: 25mg/400kcal or above more preferably 119mg/400kcal or above Pantothenic acid: 7.5mg/400kcal or above, more preferably 15.4mg/400kcal or above
• Pyridoxine 3.75mg/400kcal or above, more preferably 5.8mg/400kcal or above
• B12 vitamin 0.03mg/400kcal or above, more preferably 0.047mg/400kcal or above.
• Bl vitamin 1.3mg/400kcal or above, more preferably 2.0mg/400kcal or above.
• BIO vitamin 0.25mg/400kcal or above, more preferably 0.5mg/400kcal or above.
• the upper biotin level is less than 3.4mg/400kcal in combination with a preferred upper total other B vitamin concentration of 364mg/400kcal.
• Preferred upper concentrations of particular B vitamins are:
• Niacin 270mg/400kcal
• Pantothenic acid 40mg/400kcal
• a preferred concentration of all B vitamins, except biotin is at least 41.25mg/400kcal, more preferably at least 100mg/400kcal, or at least 146.1mg/400kcal.
• any concentration of biotin can be used with any concentration of any B vitamin.
• Examples of particular ranges in a diet/foodstuff include:
• the source of biotin or any B vitamin for inclusion in the present invention is not limiting. Suitable sources of biotin and other B vitamins include; liver, fish, eggs, milk, cereal, beans, meat, potato, nuts and concentrated forms available such as from Aldrich.
• Zinc may be included in the first aspect of the invention at a concentration of at least 5mg/400kcal, preferably at least 10mg/400kcal, more preferably above 28mg/400kcal, most preferably at least 40mg/400kcal.
• Linoleic acid may be included in the first aspect of the invention at a concentration of at least l. lg/400kcal, preferably at least 2.0g/400kcal, more preferably at least 4g/400kcal, most preferably at least 6g/400kcal.
• These levels of zinc and linoleic acid can be used in any combination (of zinc and linoleic acid) and with any combination of B vitamins and biotin according to the invention.
• any additional ingredients, including zinc and linoleic acid may be added at any time during the manufacture/processing of the diet/ foodstuff, including at the end, as the last step before packaging.
• the source of any ingredient, of the diet/foodstuff is not limiting.
• Preferred sources of zinc include zinc sulphate, zinc oxide, organic zinc complexes or a combination of two or more thereof.
• Preferred linoleic acid sources include safflower oil, sunflower oil, soyabean oil, other plant or animal oils/fats or a combination of two or more thereof.
• Concentrations of Biotin, other B vitamins and other ingredients such as zinc and linoleic acid according to the invention can easily be determined by those skilled in the art.
• the energy density for a foodstuff is stated on the foodstuff label.
• energy densities are known for individual components of a foodstuff and can be used to determine the concentration of Biotin, other B vitamins, and optionally other ingredients.
• the present invention provides a diet/foodstuff and dietary supplement which are suitable and appropriate for oral ingestion/consumption.
• a dietary supplement which, in addition to other nutrient intake, supplies a total biotin concentration of at least 0.2mg/400kcal and/ or one or more other B vitamins to a total concentration of other B vitamins of at least 33.0mg/400kcal.
• the dietary supplement supplies a total biotin concentration of at least 0.2mg/400kcal and one or more other B vitamins to a total concentration of biotin and other B vitamins of at least
• the concentrations of biotin and B vitamins in the diet/foodstuff can easily be determined by typical or guaranteed analysis declared by the manufacturer either on the label or in supplementary material or by nutritional analysis of the diet and the required amount of supplement can be added to the animal's diet. This can be done by including a quantity of the supplement with the animal's diet or by additionally feeding a quantity of the supplement to the animal.
• the supplement is preferably formed as a concentrate with extremely high levels of biotin and/ or other B vitamin(s) which requires "dilution" before feeding to an animal.
• the supplement may be in any form, preferably nori-liquid, such as a solid (e.g. a powder) or semi-solid (e.g. a food like consistency/gel), A liquid form can be mixed in with food or fed directly to the animal, for example via a spoon or via a pipette-like device.
• the supplement can be high in both biotin and one or more B vitamin or can be a combined pack of at least two components, having the required concentration of biotin and B vitamin(s) separately.
• the components of the pack may be included in a diet or foodstuff or administered simultaneously, separately or sequentially .
• the diet, foodstuff or supplement are preferably for use by animals which would benefit from the consumption thereof.
• the present invention also provides, according to a third aspect; the use of a diet or foodstuff as set out for all features of the first aspect or, a dietary supplement as set out for all features of the second aspect in enhancing and/or improving the skin and coat condition of an animal.
• the use of the diet or foodstuff is effectively a process for enhancing and/or improving the skin and coat of the animal, the process comprising providing, for oral ingestion/consumption to a non-human animal a diet and/or a foodstuff according to the first aspect of the invention. All preferred features of the first aspect also apply to this process.
• the non-human animal is a pet animal, especially a horse, or domestic cat or domestic dog.
• the types of foodstuff diet or supplement are as described above according to the first and second aspects of the invention.
• the process and/or use can be considered to be applied to a non-human animal in need thereof when such an animal has been identified, while being healthy (in particular in relation to the skin and coat conditions), to be able to have an improved and/or enhanced skin and coat condition.
• a fourth aspect of the invention provides a process for feeding a non-human animal (such as a cat or a dog) a diet, foodstuff or supplement as described above according to the first or second aspect of the invention.
• a non-human animal such as a cat or a dog
• Such a process is useful for enhancing and/or improving the skin and coat of the animal.
• the animal is preferably an individual which would benefit from the administration or consumption of the diet, foodstuff or dietary supplement.
• the process comprises providing, for oral ingestion to a non-human animal, a diet and/or foodstuff according to the first aspect of the invention. All preferred features of the first, second and third aspects apply to this fourth aspect.
• the animal is a pet animal especially a horse or a domestic cat or domestic dog.
• the types of diet, foodstuff supplement etc. are as described above according to the first and second aspects of the invention.
• This process can be considered to be applied to a non-human animal in need of the diet/foodstuff where said animal has been identified, while being healthy (in particular in relation to the skin and coat condition), to benefit from an improved and/or enhanced skin and coat condition.
• the invention is cosmetic in that it produces its effect in normal/healthy animals with good skin and coat condition, as well as those with non-clinical dry scaly skin.
• the invention and its uses can thus be described as cosmetic and/or not therapy (non- therapeutic).
• the invention does not relate to the correction of real or marginal deficiencies, rather, it provides performance enhancement for healthy animals, preferably via a complete and balanced diet. It delivers visible enhancement on animals with already good skin and coat hair condition.
• a fifth aspect of the invention provides a process for the preparation of any of the first or second aspects of the invention.
• the process comprises mixing together the ingredients (where appropriate), optionally heating to cook any raw food ingredients and presenting the mixture in a form suitable for consumption by or administration to an animal.
• any method known in the art such as in Waltham Book of Cat and Dog Nutrition, may be used.
• the biotin and B vitamins can be introduced into the mixture at any stage.
• the diet or foodstuff is a wet or dry product.
• the supplement and/or composition is a powder [or liquid] .
• a sixth aspect of the invention provides the use of biotin and/or one or more other B vitamins in the manufacture of a non-human diet or foodstuff according to the first aspect of the invention or in the manufacture of a non-human supplement according to the second aspect of the invention.
• the first and second aspects of the invention are as hereinbefore described. All preferred features of the first and second aspects as hereinbefore described above are covered by this sixth aspect of the invention.
• the manufacture of the diet foodstuff and supplement are according to well known methods and procedures of the art.
• the enhancement and/or improvement in the skin and coat condition of an animal may be determined by a comparison of the skin and coat condition when the animal is fed the same diet or foodstuff without biotin and other B vitamins; or when the animal is feed the same diet or foodstuff with biotin and other B vitamins at the separate (biotin separate from other B vitamin levels) or combined levels as set out for the control in table 2 of the example which follows.
• Improvements in skin and coat conditions according to the invention may also be associated with improved skin barrier function by the reduction of transepidermal water loss.
• Improvements in skin and coat condition may be determined by a quantitative descriptive analysis panel.
• This panel involves a specialist group of people to assess a number of characteristics of the animals being tested. This form of analysis is currently used in the cosmetics and health-cafe products in industry evaluation of and is described as follows:
• QDA Quantitative Descriptive Analysis
• assessors are animal owners, then care should be taken to ensure, that if a trial animal has the same visual appearance (e.g. colour or breed), there is no bias in terms of favourable scoring.
• a small, well-trained panel is much better than a large untrained panel.
• 20 potential candidates are selected, who demonstrated the necessary skills (listed above - section viii) at interview. These 20 people then began a training course, lasting approximately 12 hours over 3 days. During the first day the panel were introduced to the principles of assessment with 5 reference cats. The assessors were then asked to assess 8 cats, of differing colours and coat types, two of which were the same cat (we pretended they were sisters!). This test monitors the consistency of individuals, looks at their ability to use the scale properly and can be used to compare their score against the panel mean to eliminate any biases. They were also asked to smell 3 dogs and rank them in order of offensiveness. This gave us an indication of how well the assessors handled the dogs and cats and an indication of their sensory skills. The best 10 assessors were selected to complete the next training session.
• the animal should be assessed in a random order, at each assessment stage, to eliminate any bias towards the first or last animals presented. ⁇ Between each assessment the assessors should wipe their hands with an alcohol tissue or wash them with soap and water.
• Each animal should be examined by the assessors as a group but, to avoid any effect of change sin coat texture during handling, the assessors should touch each animal in the same sequence.
• Each animal should be assessed under identical conditions, preferably indoors, to provide an even and consistently lit area.
• the coat Prior to evaluation, the coat should be combed evenly all over, in a standardised manner, to eliminate the influence of any disturbances in the way the coat is lying. A clean comb should be used for each animal. Combs should be de- greased in alcohol or methylated spirits.
• the sensory evaluation techniques rely upon a critical judgement made on each occasion.
• the assessors must understand that they are making an independent evaluation of an animal on a specific occasion.
• the assessors must be blind to all treatment groups that the animals may belong to. There is no harm however in giving some information about the trial e.g. something has been added to the diets of some of the animals to see if it has any effects on any aspects of the animals' coat condition. They may help to keep their interest levels high and make them feel they are doing a worthwhile job.
• the scoring system to be used should comprise a numerical scale for each parameter under evaluation.
• the scale is a simple category scale with a minimum of 5 categories for the purpose of statistical analysis.
• the scale currently used by the QDA panel appears to be a line scale, but is in fact used as a category scale i.e. crosses are only marked on the whole and half numbers and not anywhere along the line.
• Scale the animal's body needs to be visually sectioned off into six areas. Assessments should be carried out, section by section, lifting the hairs in the opposite direction of growth, examining the skin and base of the hairs for signs of flaking. N.B. lighter coats may need very careful inspection. The scores, for each section, are then summed for the whole body and translated onto the scoring line. By dividing the body into six, the most accurately scored parameter has been created.
• FIGURE 1 is a graph showing changes in coat softness.
• FIGURE 2 is a graph showing improvements in coat scale.
• FIGURE 3 is a graph showing change in coat feel.
• FIGURE 4 is a graph showing the reduction in transepidermal water loss and improvements in skin barrier function.
• the trial was conducted utilising 16 black adult Labradors.
• the dogs were fed te maintain their body weight and therefore body weights were monitored weekly. Amounts offered were adjusted to compensate for any excessive gain or loss of bodyweight.
• the final levels of all supplements offered to the dogs are shown in Table 2.
• the base levels of the ingredients are those indicated in the 'control' panel.
• Total (test) levels are base levels plus supplement and are shown in Panel 2.
• the energy requirement of each animal was calculated at the beginning of each feeding stage and the amount offered was adjusted accordingly. Individual food intakes were recorded daily for each dog. Individual weekly body weights were measured to monitor and correct any over- or under-feeding.
• Quantitative Descriptive Analysis was composed of five women who have been selected and trained, in house, to provide accurate and precise assessments of coat quality (for details refer to QDA described earlier).
• Coat softness is a measure of the feel of the coat when the assessors run fingers through the full thickness of the coat.
• Optimum coat feel is an absence of either a greasy or a dry feel of the coat (as often the two are indistinguishable on the basis of feel alone) and was measured at the same time as the softness. This parameter is subdivided into two measurements; along the top of the back and along the flanks, as there is variability between these areas. Scale (dander) on the animal's coat was an undesirable quality and is measured by visually assessing the amount of scale present in three different sections of the dogs' coat.
• Skin hydration was evaluated by measuring the conductivity of the skin using a dermal phase meter which yields a direct measure of the hydration of the stratum corneum. Continuous measurements taken over a 30 second period provide an indirect measure of transepidermal water loss. Measurements were taken in duplicate at the end of the prefeed stage (weeks 8 and 9) and at the end of the test phase (weeks 17 and 18) from the inner surface of both left and right ears. These provide a direct assessment of skin barrier function.
• a reduction in non-clinical scale or dander plays a major role in the achievement of a superior skin and coat condition in animals (cosmetic appearance) .
• Biotin plus B vitamins in the levels specified, are ingredients which reduce scale or dander in healthy animals.
• Biotin plus B vitamins in the levels specified according to the invention significantly reduce transepidermal water loss thereby improving the barrier function and hydration of the skin. It is possible that this increase in hydration of the skin is linked with the reduced amount of scale on the animal's skin hair, via the action of these vitamins in promoting healthy skin growth. Supplementation of a diet with biotin plus B vitamins shows an improvement in coat softness.

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• 1998
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