Abstract: The present invention relates to a dietary formulation enriched with omega-3 fatty acids in the form of syrup, consisting essentially of: alpha-linolenic acid (ALA), docosahexaenoinc acid (DHA), linoleic acid (LA) and oleic acid (OA) recommended for consumption by children or young adults with or without vitamins and minerals. The present invention of syrup containing omega-3 fatty acids also carries sufficient dose of Phosphatidylcholine (PC) derived from vegetarian sources. The syrup can be prepared in various flavors like chocolate, strawberry, vanilla and many others. The fortified syrup provides between 0.5-2.0% of alpha-linolenic acid (ALA) and 0.5-2.0% of docosahexaenoic acid (DHA) per serving. The omega-3 fatty acids remain uniformly dispersed and the product has no harsh off-notes or bitter after taste. The final syrup is a stable and acceptable formulation for consumption by children and adults.
Claims:1. The present invention claims the syrup suitable for children or adults consumption containing essential fatty acids like alpha-linolenic acid (ALA), linoleic acid (LA) and docosahexaenoic acid.
2. The present invention claims the syrup suitable for children or adults consumption containing multi-vitamins or minerals along with essential fatty acids like ALA, DHA and LA.
3. The present invention claims the syrup offering various doses of ALA (0.5 to 2.0 % w/w) and DHA (0.5 to 2.0 % w/w/) per serving (10.0 to 20.0 grams).
4. The present invention claims syrup available in flavours like chocolate, vanilla, strawberry etc. containing essential fatty acids like ALA, LA and DHA with or without multi-vitamins or minerals.
5. The syrup claims use of vegetable source of oils containing ALA, LA and DHA.
6. The formulation claims the syrup containing essential fatty acids in the form of triglycerides, free fatty acids or methyl, ethyl esters of fatty acids or salts of fatty acids.
7. The formulation claims use of phosphatidylcholine (PC) along with fatty acids like ALA, LA and DHA.
8. Present invention claims use of syrup formulation containing omega-3 fatty acids with or without multi-vitamins and minerals in milk, ice cream, bread, cookies, and other food products as ready-to-eat syrup.
9. Present syrup claims no undesirable or off taste or odour development during or after preparation due to addition of vegetable oils containing ALA and DHA.
10. The formulation claims the syrup of omega-3 fatty acids to be physically and chemically stable when kept stored at lower temperature and away from light and air.
11. The syrup of omega-3 fatty acids formulation which claims the use of a food grade colorant (natural or synthetic) and food grade flavoring agent (natural or synthetic) in recommended quantity whenever required.
12. The syrup claims formulation which can be used by children and adults as direct consumable or ready-to-eat product.
, Description:Field of Invention
The present invention relates to aqueous syrup having omega-3 fatty acid content suitable for the consumption of children or young adults providing essential fatty acids like alpha-linolenic acid (ALA) and docosahexaenoinc acid (DHA) for the growth and development of the brain, eyes, skin and bones and other associated health benefits. The syrup offers acceptable, convenient and unique dosage forms of the omega-3 fatty acids including alpha-linolenic acid (ALA), docosahexaenoinc acid (DHA), linoleic acid (LA) and oleic acid (OA). The present invention relates to food products having omega-3 fatty acids, vitamins and minerals suitable for the consumption of children or young adults. The syrup can have a variety of flavors (chocolate, strawberry, vanilla etc.), and serve as a vehicle for the delivery of omega-3 fatty acids like ALA and DHA along with or without vitamins and minerals.
Background of the invention
Essential fatty acids are those which cannot be synthesized by the body itself. There are only two essential fatty acids – ALA (alpha-linolenic acid) and LA (linoleic acid). The derivatives of these fatty acids (EPA and DHA) are not essential as they can be synthesized in the body by their parent compound [1]. Though the biochemical conversion of ALA into DHA and EPA does not provide sufficient quantities required to meet healthy levels of DHA and EPA in an individual [2]. Alpha-linolenic acid plays a pivotal role in brain function during the course of aging by contributing in ketogenesis. LA is less preferred for the process of ketogenesis [1]. The incorporation of ALA in the membrane phospholipids makes it more flexible and responsive [3-4]. The ALA is important for the growth and development of infants. It is supplied to infants by breast milk which has 0.5- 2% ALA content [5-8]. ALA is important for brain function as its deficiency may cause improper growth and neurological problems [9-14]. There was a notable increase in the levels of brain-derived nuerotrophic factor (BDNF), which has manifold functions in the brain activity. Diets rich in ALA increase the total omega-3 content of cell membrane phospholipids [15]. ALA and its derivatives reduce the risk of obesity by enhancing the oxidation process [16-17]. ALA maintains and improves heart heath, eye health, lipid profile, blood pressure and is anti-inflammatory [18-21].
DHA is a crucial long chain polyunsaturated fatty acid and has many important roles in our body especially during pregnancy and during the first year after birth as it is essential for the development and working of the brain and visual systems [22-23]. It is important for blood glucose transport, signal transduction and gene expression in brain and also has a major role in neurodevelopment and neurite formation and growth [24-26]. However, the dietary need of DHA cannot be fulfilled by ALA alone as it is directly converted into EPA and DHA in low concentrations [2]. To meet the daily requirements of these fatty acids, they must be incorporated in the diet in the form of supplements or fortified food products. Especially, for children below the age of 10, daily diet must meet the recommended dietary intake. DHA makes up a large portion of the brain and the retinas of the eyes therefore most important in children for the health and development of brain, eyes, central nervous system development. During pregnancies, DHA formed in the mother’s body is provided to the growing fetus; however DHA is formed in small quantities and is unable to meet the requirements of two individuals. Therefore, DHA supplementation is suggested to pregnant women. DHA is important for maintaining heart health, neural development, healthy vision, normal blood pressure, normal triglyceride levels etc. The daily dietary intake dictates the consumption of 100 mg DHA per day. DHA is scarce in vegetarian sources and this act as a barrier for some people. ALA on the other hand, is easily available in both vegetarian and non-vegetarian sources. The required intake of ALA is high during pregnancies and early years of childhood as it performs many crucial roles in the body, most important being prevention against inflammatory responses. It also helps in the maintaining the high- density and low-density lipid levels [27-28].
The syrup also supplies vitamin A, C, D and E in concentrations suitable for consumption by pregnant women, lactating women and children and young adults. Vitamin A, C and E have anti-oxidant properties which prevents cell damage.
Vitamin E is one of the fat-soluble vitamins, which can be found in many vegetables and fruits amongst vegetarian sources and also in eggs and meat. Vitamin E deficiency is rare but has been recorded in most premature or low-weight infants or in cases of late pregnancies. Vitamin E supplements are prescribed in such cases. Also, women experiencing pre-menstrual syndrome, painful menstruation, and menopausal syndrome use Vitamin E supplements. The main attribute of these benefits of Vitamin E is its anti-oxidant behavior, which prevents any inflammatory damage to the cells. The recommended daily intake of Vitamin E is 18 IU and there are very few sources that have the required Vitamin E content per serving. Sunflower seed oil (without shells) is the only plant source delivering the exact dietary requirement per 60 ml of the oil. However, it is not possible to consume this amount on a daily basis because of other risk factors associated with oil consumption. Vitamin E is the key for strong immunity, healthy skin and eyes. In recent years, vitamin E supplements have become popular as antioxidants. These are substances that protect cells from damage. Vitamin C and Vitamin E play role in collagen formation and development of nervous system respectively.
Vitamin A protects the eyes and enhances vision. Universally known for its best health benefits, Vitamin A is the key for good vision, a healthy immune system, and cell growth in children of all ages and groups. Vitamin A, having a RDI of 2000IU, is crucial for immune function. There are two counterparts for Vitamin A- one having an animal source (retinol) and another originating from plant source (beta-carotene). Pregnant women and people with digestive disorders are at risk of Vitamin A deficiencies and need to take supplements. Orange, carrot, eggs and meat etc. are rich in Vitamin A content but one has to consume large quantities of these foods.
Vitamin D acts like a pro-hormone and helps in development of brain function and immune system. Vitamin D has historically been associated with strong bones; recent research has found that it may also be an important factor in maintaining a healthy immune system. Vitamin D also protects children from Attention Deficit Hyperactivity Disorder (ADHD), body fat and helps to gain more lean muscle mass. Deficiency of Vitamin D in world population is very common and is leading to health issues. Vitamin D helps in maintaining bone and teeth integrity and can be produced in the body in response to sun exposure. Children having Vitamin D deficiencies are at risk of developing atopic allergic diseases like eczema and/or asthma. Vitamin D also helps in reducing the risk of high blood pressure during pregnancies.
Ascorbic acid or Vitamin C is important for development and repair of body tissues. It plays crucial roles in almost every aspect of growth, progression and well being of a human body. It helps in collagen formation, iron absorption, wound healing, and maintaining bone health and in many other processes. The main highlight of this vitamin is that one does not have to worry about consuming excess of it as it is not stored in the body. However, one should not consume it more than 2000 mg per day. Vitamin C can provide immunity against cold and other infections. Additionally, vitamin C helps to improve cardiovascular health, prenatal health, eye health and skin health.
Phosphatidylcholine (PC) serves as the body’s main source of choline, an essential nutrient and precursor to the neurotransmitter, acetylcholine. It’s most common uses include brain health, memory and concentration management.
The present syrup is suitable for consumption by children and/or pregnant women as it fulfills the daily requirements of essential vitamins and minerals essential for the progression of healthy gestation and over all development of the child. The ingredients used in the syrup are non-allergic and acquired from vegetarian sources, which prevents occurrence of any hyper-sensitive reaction in pregnant women and children.
The product can be formulated in a variety of flavors and it serves as an agent for the delivery of essential fatty acids with or without minerals and vitamins.
Summary of the Invention
The objective of the present invention is to formulate a syrup-based product containing omega-3 fatty acids with or without vitamins, phosphatidylcholine and minerals required for healthy growth of children and adults. The invention also ensures to provide the added omega-3 fatty acids, vitamins and mineral to its nearest possible doses as per recommendations per serving size without any unacceptable taste imparted by DHA oil.
The syrup formulated in present invention does not have a granular texture or unpleasant taste. The syrup can be consumed in many different ways and can be formulated in different flavors. The omega-3 fatty acids containing syrup is a ready-to-use formulation which can be consumed directly using spoon or can be easily mixed and homogenized in milk. Furthermore, the syrup can be given with breads, ice creams, cookies of any other edible form as toppings.
Detailed Description of the Invention
The invention discloses embodiment (s) which carry the salient features of this invention and merely typify the scope. The scope of the invention presented by embodiment (s) is not limited to disclosures hereby but defined by the claims affixed.
The present invention discloses a novel formulation where essential omega-3 fatty acids like ALA and DHA derived from vegetarian sources with or without multi-vitamins, minerals and phosphatidylcholine. The syrup ensures supply of adequate quantities of essential fatty acids like alpha-linolenic acid (ALA), linoleic acid (LA) and docosahexaenoic acid (DHA).
The present invention explains the formulation of a syrup based concoction containing LA, ALA, and DHA for better development of kids. The fatty acids fortified in the syrup are derived from vegetarian sources and it prevents the cases of intolerance, generally observed with marine sources.
The present invention discloses a novel method wherein stable and readily dispersible oil in water (o/w) syrup based emulsion is prepared. The syrup comprises of a sweetening agent, a flavoring agent and food grade emulsifiers to aid the mixing of oils in the aqueous syrup.
The term ‘omega-3 fatty acids’ used herein may refer to LA, ALA, OA, and DHA or a combination of the mentioned fatty acids. The term omega-3 fatty acids include these fatty acids as triglycerides, free fatty acids, ester of fatty acids or salts of fatty acids. The fatty acids are added in suitable amounts that fulfill the daily requirements of the omega-3 fatty acids in such a way that does not impart any unpleasant odor, taste or texture.
The present invention is aqueous syrup fortified with essential fatty acids. The oils used in the invention are in the form of triglycerides. However, free fatty acids, methyl/ethyl esters can also be used. This fortified syrup can be consumed with milk, milk shakes, smoothies, ice-creams, cakes, puddings, bread and many other dairy and confectionery products.
Minimum quantity of food grade emulsifiers (0.05 to 0.1%) is used to formulate safe and healthy syrup which is suitable for consumption by children and young adults and also pregnant and/or lactating women. The emulsifier used in the present emulsion preparation refers to any substance which enhances the emulsion stability and remains uniformly dispersed in continuous liquid phase. A wide range of emulsifiers with HLB value range 8-18 were used for o/w emulsions. The emulsifier used in the present syrup are, but not limited to, polysorbate 80 (E433), xanthan gum (E415), glycerol monostearate (E471). The sweetening agent is used in concentrations suitable to prevent the development of fungal contamination and to maintain the consistency of the syrup. Aforementioned emulsifiers can be used as single component or in combination as a mixture thereof. The oil-in-water (o/w) emulsion based syrup of the present invention comprises use of one or more antioxidants. The list of antioxidants which are used, but not limited to, includes tocopherol (vitamin E), ascorbic acid or ascorbyl palmitate (fat soluble vitamin C), retinol and/or beta-carotene (Vitamin A) individually or as combinations thereof.
As an embodiment, use of thickening agent involves, but not limited to use of, monosaccharide like glucose and/or fructose and disaccharide like sucrose as single component or in combination thereof. The list of thickening agents may include sugar alcohols like mannitol and sorbitol. In some embodiments, the invention of syrup includes use of food grade antimicrobial agents like, but not limited to, sodium benzoate and potassium sorbate. Their use is limited as per regulations established for food products which would be fortified with omega-3 fatty acids.
According to an embodiment, the present invention finds prepared syrup physically and chemically stable. Physical stability includes features like homogeneous mixture, free from phase separation, free from coagulation or flocculation and free from creaming when stored for a sufficient time under normal conditions. Chemical stability includes a stable range of pH from 4.5-6.5 at all concentrations and requires no buffering agent. The emulsion is able to retain its kinetic stability for a considerable long time and emulsion break-down process is found really slow. Physical and chemical parameters defining destabilization were observed for stable for a longer time when measured to evaluate the intended life of the product.
As one more embodiment, present invention offers an enhanced ‘shelf life’ in terms of oxidation or degradation. Omega-3 fatty acids including ALA, DHA or EPA of their combinations thereof are susceptible to oxidation or degradation in presence of air and light. The emulsion was found to show no or small change in peroxide value when studied at various time intervals with respect to pure omega-3 fatty acids kept and studied under identical conditions.
Examples
Example 1:
A blend of ALA oil, DHA oil, multi-vitamins (A, D, E and C), minerals and phosphatidylcholine has been used as discontinuous phase to prepare oil in water emulsion based syrup of omega-3 fatty acids as food ingredient. The omega-3 fatty acids present in the blend of oils are present in form of their natural triglycerides. Polysorbate-80 has been used as an emulsifier. Dextrose and fructose mixture was used as sweetener and thickening agent and dissolved prior in purified water. The oil phase containing emulsifier is slowly added to the water phase comprising thickening agent. The cocoa powder added acts like a flavoring agent as well as a thickening agent. The mixture is rigorously stirred at 2500 RPM of in-house designed homogenizer. The homogenizer design ensures high energy transfer to mixture in short duration of time. Temperature of the sample is maintained around 25-300C throughout the process. Mixture when agitated and mixed for a considerable time is tested for its properties. The prepared sample is then evaluated for physical and chemical stability parameters like creaming, phase separation, coagulation, peroxide calculation, viscosity, rancidity and many others.
Example 2:
A blend of ALA oil, DHA oil, multi-vitamins (A, D, E and C), minerals and phosphatidylcholine has been used as discontinuous phase to prepare oil in water emulsion based syrup of omega-3 fatty acids as food ingredient. The omega-3 fatty acids present in the blend of oils are present in form of their natural triglycerides. Glycerol Mono-Stearate (GMS) is used as an emulsifier. Dextrose and fructose mixture was used as thickening agent and dissolved prior in purified water. The flavoring agent (strawberry) along with food color (strawberry) and xanthan gum are homogenized in the water phase. It may require heating upto 60-70oC to ensure proper mixing of xanthan gum. The oil phase containing emulsifier is slowly added to the water phase comprising thickening agent. The mixture is rigorously stirred at 2500 RPM of in-house designed homogenizer. The homogenizer design ensures high energy transfer to mixture in short duration of time. Temperature of the sample is maintained around 25-300C throughout the process. Mixture when agitated and mixed for a considerable time is tested for its properties. The prepared sample is then evaluated for physical and chemical stability parameters like creaming, phase separation, coagulation, peroxide calculation, viscosity, rancidity and many others.
References
Cited Patents
Cited Patent Publication date Inventor Applicant Title
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Mary Ellen Kline, Malathy Nair The Hershey Company Fortification of syrup with calcium and other minerals and vitamins
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Ann Coric, Louis C.
Sanfilippo Cenestra LLC Omega 3 Fatty acid formulations
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| Section | Controller | Decision Date |
|---|---|---|
| # | Name | Date |
|---|---|---|
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| 1 | 201821021236-Written submissions and relevant documents [01-11-2021(online)].pdf | 2021-11-01 |
| 2 | 201821021236-REQUEST FOR EXAMINATION (FORM-18) [06-06-2018(online)].pdf | 2018-06-06 |
| 2 | 201821021236-FORM 13 [21-10-2021(online)].pdf | 2021-10-21 |
| 3 | 201821021236-REQUEST FOR EARLY PUBLICATION(FORM-9) [06-06-2018(online)].pdf | 2018-06-06 |
| 3 | 201821021236-FORM-26 [21-10-2021(online)].pdf | 2021-10-21 |
| 4 | 201821021236-POA [21-10-2021(online)].pdf | 2021-10-21 |
| 4 | 201821021236-FORM-9 [06-06-2018(online)].pdf | 2018-06-06 |
| 5 | 201821021236-RELEVANT DOCUMENTS [21-10-2021(online)].pdf | 2021-10-21 |
| 5 | 201821021236-FORM FOR SMALL ENTITY(FORM-28) [06-06-2018(online)].pdf | 2018-06-06 |
| 6 | 201821021236-FORM FOR SMALL ENTITY [06-06-2018(online)].pdf | 2018-06-06 |
| 6 | 201821021236-FER.pdf | 2021-10-18 |
| 7 | 201821021236-US(14)-HearingNotice-(HearingDate-21-10-2021).pdf | 2021-10-18 |
| 7 | 201821021236-FORM 18 [06-06-2018(online)].pdf | 2018-06-06 |
| 8 | 201821021236-FORM 1 [06-06-2018(online)].pdf | 2018-06-06 |
| 8 | 201821021236-CLAIMS [21-06-2021(online)].pdf | 2021-06-21 |
| 9 | 201821021236-FIGURE OF ABSTRACT [06-06-2018(online)].pdf | 2018-06-06 |
| 9 | 201821021236-FER_SER_REPLY [21-06-2021(online)].pdf | 2021-06-21 |
| 10 | 201821021236-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [06-06-2018(online)].pdf | 2018-06-06 |
| 10 | 201821021236-OTHERS [21-06-2021(online)].pdf | 2021-06-21 |
| 11 | 201821021236-COMPLETE SPECIFICATION [06-06-2018(online)].pdf | 2018-06-06 |
| 11 | 201821021236-EVIDENCE FOR REGISTRATION UNDER SSI [06-06-2018(online)].pdf | 2018-06-06 |
| 12 | 201821021236-DECLARATION OF INVENTORSHIP (FORM 5) [06-06-2018(online)].pdf | 2018-06-06 |
| 13 | 201821021236-COMPLETE SPECIFICATION [06-06-2018(online)].pdf | 2018-06-06 |
| 13 | 201821021236-EVIDENCE FOR REGISTRATION UNDER SSI [06-06-2018(online)].pdf | 2018-06-06 |
| 14 | 201821021236-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [06-06-2018(online)].pdf | 2018-06-06 |
| 14 | 201821021236-OTHERS [21-06-2021(online)].pdf | 2021-06-21 |
| 15 | 201821021236-FER_SER_REPLY [21-06-2021(online)].pdf | 2021-06-21 |
| 15 | 201821021236-FIGURE OF ABSTRACT [06-06-2018(online)].pdf | 2018-06-06 |
| 16 | 201821021236-CLAIMS [21-06-2021(online)].pdf | 2021-06-21 |
| 16 | 201821021236-FORM 1 [06-06-2018(online)].pdf | 2018-06-06 |
| 17 | 201821021236-FORM 18 [06-06-2018(online)].pdf | 2018-06-06 |
| 17 | 201821021236-US(14)-HearingNotice-(HearingDate-21-10-2021).pdf | 2021-10-18 |
| 18 | 201821021236-FER.pdf | 2021-10-18 |
| 18 | 201821021236-FORM FOR SMALL ENTITY [06-06-2018(online)].pdf | 2018-06-06 |
| 19 | 201821021236-FORM FOR SMALL ENTITY(FORM-28) [06-06-2018(online)].pdf | 2018-06-06 |
| 19 | 201821021236-RELEVANT DOCUMENTS [21-10-2021(online)].pdf | 2021-10-21 |
| 20 | 201821021236-POA [21-10-2021(online)].pdf | 2021-10-21 |
| 20 | 201821021236-FORM-9 [06-06-2018(online)].pdf | 2018-06-06 |
| 21 | 201821021236-REQUEST FOR EARLY PUBLICATION(FORM-9) [06-06-2018(online)].pdf | 2018-06-06 |
| 21 | 201821021236-FORM-26 [21-10-2021(online)].pdf | 2021-10-21 |
| 22 | 201821021236-REQUEST FOR EXAMINATION (FORM-18) [06-06-2018(online)].pdf | 2018-06-06 |
| 22 | 201821021236-FORM 13 [21-10-2021(online)].pdf | 2021-10-21 |
| 23 | 201821021236-Written submissions and relevant documents [01-11-2021(online)].pdf | 2021-11-01 |
| 23 | 201821021236-STATEMENT OF UNDERTAKING (FORM 3) [06-06-2018(online)].pdf | 2018-06-06 |
| 1 | searchE_29-12-2020.pdf |