FORM 2
THE PATENT ACT, 1970 (39 of 1970)
COMPLETE SPECIFICATION
[See sections 10; rule 13]
'Dietary Oil
Recon Oil Industries Private Limited
5, Chunawala Estate, Kodhntta Road
J.B.Nagar, Andheri (East), P.O.Box No.- 7415
Mumbai- 400 059, State of Maharastra
India, an Indian Company.
The following specification particularly describes the nature of this invention and the manner in which it is to be performed:



FIELD OF THE INVENTION
The present invention relates to heat stable dietary edible oil incorporating benefit actives EPA / DHA in heat and storage stable form which would be safe and healthy for regular consumption and serve as an effective medium for preventing cardiovascular ailments especially those related to high cholesterol levels in humans and also to the process for its manufacture. Importantly, the dietary oil of the invention is directed to provide beneficial / therapeutic benefit on regular consumption thereby take care of present day health concerns mainly undesirable increase in cholesterol, triglyceride and platelet stickiness to the blood vessels / walls.
BACKGROUND ART
It is well known that accumulation of excess cholesterol and triglyceride are two known predictors for coronary risk and a study conducted by WHO put more emphasis on excess triglyceride which appears to be a stronger predictor for coronary mortality.
Clinical trials conducted by National Institute of Nutrition, Hyderabad, India, have proved beyond doubt that conventional ingredients of dietary oils such as monounsaturated fatty Acids (MUFA) oleic (n-9), poly unsaturated fatty Acids (PUFA)-Linoleic (n-6) and Alpha Unolenic Acid ALNA (n-3) i.e. normal oils and fats used for cooking including safHower oil, sayabean oil, Groundnut oil etc. which can not reduce triglyceride level in cerum lipid and also can not increase HDL level in cerum lipid which helps to remove excess cholesterol.
It is known that very low-density lipo-protein (VLDL) and low density Lipo-Protein (LDL) both of which are derivatives of ingested oils carry cholesterol to the cells (normal body function) irrespective of body requirement. On the other hand, high density Lipo-protein (HDL), another derivative of ingested oil transports back excess cholesterol to liver for disposal.
Therefore in order to maintain cholesterol level within the normal range, it is desirable to have reduced level VLDL and LDL and increased level of HDL to maintain cholesterol level in the normal range and also to reduce triglyceride level in cerum lipid.
It is anticipated that because of life style changes, a very large section of the population is likely to have cardio-vascular problems. Therefore, dietary cooking oil having beneficial effects namely reduction of VUDL/LDL, increase in HDL, reduction of TRIGLYCERIDE level and reduction of tendency of 'platelets' to dump and adhere to the

blood vessel walls and related contraction of the blood vessel themselves would go a long way for overall health care as oils are used daily and by all members of the family.
It is known that Eicosa Pentaenoic Acid (EPA) and Docosa Hexaenoic Acid (DHA) have therapeutic values as actives capable of reducing the cholesterol level in the body and favour maintaining good health conditions espetially by safe guarding against coronary risks associated with high cholesterol levels in the body.
However, inspite of the above therapeutic values of EPA / DHA it had been extremely difficult to directly administer effective amounts of said EPA / DHA due to its highly unsaturated and consequential unstable nature. Thus attempts to introduce such EPA / DHA directly in humans resulted in immediate breakdown of the active constituents of EPA / DHA in the body and consequential failure to achieve the desired health benefits in its administration/in take. Thus to meet such known problems of administration of EPA / DHA due to its inherent instability, it is known to provide EPA / DHA encapsulated in capsules wherein the active EPA / DHA was maintained in a protective environment until it was required to deliver its advantageous benefit action in the body. Such required provision of the EPA / DHA in the encapsulated form necessarily affected its wide scale and advantageous use as a benefit agent
The above state of the art reveal the need for regular intake of EPA / DHA in a form suitable for regular consumption for controlling the cholesterol level in the body. The known provision of the active EPA / DHA in capsule for therapeutic use is found to be not convenient for such desired regular and wide scale consumption and do not serve the purpose of the much desired availability of said EPA / DHA in the body as a cholesterol controlling active on regular basis for maintenance of better health and safe living.
OBJECT OF THE INVENTION
It is thus the basic object of the invention to provide for dietary edible oil having selective blend of the cholesterol controlling Eicosa Pentaenoic Add (EPA) and Docosa Hexaenoic Add (DHA) which would serve as the much required alternative media for administering /delivering the therapeutically active and benefidal but usually highly unstable Eicosa Pentaenoic Add (EPA) and Docosa Hexaenoic Add (DHA) in humans by way of a regularly consumable product and also be an effective heat stable cooking media for various cooking purposes.

Another object of the present invention is to provide for a dietary edible oil which would serve as an effective edible cooking media and which upon regular consumption can advantageously lower very low density lipoprotein (VLDL) and low density lipoprotein (LDL) and in the process avoid carrying excess cholesterol to the cells and in effect have therapeutic values in controlling cholesterol level in blood on regular consumption.
Another object of the present invention is to provide for a dietary edible oil which would favour increasing the level of high density lipoprotein (HDL) which assist in carrying of excess cholesterol accumulated in blood stream back to liver for disposal and in turn also contribute towards control over cholesterol level in blood on regular consumption.
Yet further object of the present invention is to provide for dietary edible oil which can reduce triglyceride level and hence avoid coronary risk associated with excess triglyceride. This can not be controlled by conventional edible oils.
Yet further object of the present invention is directed to dietary edible oil which can effectively contribute towards reducing tendency of platelets to clump and adhere to the blood vessel walls and even contraction of blood vessel resulting from consumption of dietary oils.
Yet further object is directed to dietary edible oil which can be safely consumed on a regular basis by every member of the family as a cooking media and in the process provide continuous benefits in terms of maintenance of health and body constitution.
Yet further object is to provide for dietary edible oil which apart from functioning as an effective edible cooking media would also serve as a therapeutic agent in maintenance of health and body constitution and assist in achieving significant control of triglyceride and / or cholesterol related cardiac risks / problems.
Yet further object of the present invention is to provide for dietary oils which apart from serving as a safe and healthy cooking media would also essentially be heat stable and facilitate proper and effective purposes as a cooking media.
Yet further object of the present invention is directed to provide for a synergistic dietary edible cooking oil composition which would favor safe and healthy to eat cooked foods and at the same time will have better shelf life and stable to favour variety of preparations at varied temperatures.
Yet further object of the present invention is directed to provide a heat stable edible dietary oil based supplement for controlling over weight and / or cardio vascular diseases.

SUMMARY OF THE INVENTION
Thus according to the basic aspect of the present invention there is provided a heat stable dietary edible oil comprising a selective amount of 0.5 to 20% of at least one of Eicosa Pentaenoic Add (EPA) and Docosa Hexaenoic Add (DHA) maintained heat stable in combination with edible oil constituents / ingredients.
It has surprisingly been found by way of the present invention that a selective mix of the said Eicosa Pentaenoic Add and / or Docosa Hexaenoic Acid in cooking oil formulations provide for a selective / synergistic combination which enable providing the desired benefit actives of EPA / DHA in a regularly consumable form without the need for its protective encapsulated form. Importantly, the dietary edible oil of the invention by way of its selective incorporation of EPA / DHA achieves surprising and unexpected heat and storage stability as a cooking media and provide the much desired alternative and more convenient route for consumption of the required EPA / DHA on a regular basis to make benefit use of the known health benefits of such EPA / DHA as a cholesterol controlling agent. Thus the dietary blend containing EPA / DHA of the invention on one hand maintain the desired constitution of the oil for cooking purpose i.e. required heat and storage stability and on the other hand impart the desired health and safety benefits to the basic dietary oil through incorporation of the therapeutically valuable EPA / DHA in selective amounts to favour atieast one of a) redudng the very low density lipoprotein (VLDL) and low density lipoprotein (LDL) to control cholesterol levels, b) elevating high density lipoprotein another fat derivative (HDL) to favour effective disposal of accumulated cholesterol c) reduce the formation of triglycerides and d) reduce tendency of 'platelets' to dump and adhere to the blood vessels walls and related contraction of the blood vessels themselves.
In accordance with a preferred aspect of the present invention there is provided a heat stable dietary edible oil comprising a selective amount of 0.5 to 10% of EPA and / or DHA in combination with edible oil constituents / ingredients.
Importantly, it is found by way of the present invention that the problems assodated with administration of EPA / DHA, being highly unsaturated other than in its encapsulated form having very limited use, can be avoided by its selective combination with edible oil sources to maintain desired shelf life and heat stability for such product apart from the intended health benefits discussed above.
The above selective range of incorporation of EPA and / or DHA provides for the desired selective heat stability restoring further the intended health benefits in its incorporation in the edible oil formulations. Thus, the above selective range apart from providing the

desired health benefits to the edible oil ensures heat stability of the product and avoids unwanted "free radical" formation.
In accordance with a further preferred aspect of the present invention the dietary edible cooking oil preferably comprises a fatty Acid distribution of :
- saturated fatty Acids (SFA): up to 25%;
- mono unsaturated fatty Acids (MUFA): preferably more than 40% and
- polyunsaturated fatty Adds (PUFA) : 20-35% including said selective EPA and / or DHA.
In the above composition the said PUFA fatty can preferably comprise linoleic Add (C 18:2 n-6), Alfa-linolenic Add (ALNA) (C 18:3 n-3) and also indude EPA / DHA (C 20:5 n-3 and C 22:6 n-3).
In the above dietary oil blend of the invention the source of said Eicosa Pentaenoic Add (EPA) and / or Docosa Hexaenoic Add (DHA) indude fish oil, algae oil, marine mammals, sea fish and sea birds. Algae spedes grown in feimentors are also good source of the DHA.
The cooking oil source in the blend can indude conventional Groundnut oil, Ricebran oil, Soyabean oil, Com Oil, Palm oil, and mixtures thereof induding hydrogenated, fractionated and interesterified oils. The blend can additionally contain known additives to conventional dietary edible oils permitted antioxidants, such as TBHQ, BHA, Tcopherol etc.
In accordance with a further aspect the process of manufacture of the EPA / DHA fortified heat stable dietary oil comprise:
incorporating a selective amount of 0.5 to 20% preferably 0.5 to 10% of EPA and / or DHA in edible oil constituents / ingredients such as to maintain desired heat stability of the blend as a cooking media.
In accordance with another aspect of the present invention there is provided the process of manufacture of the EPA / DHA fortified heat stable dietary oil comprising: incorporating selectively a fatty Add distribution of:
- saturated fatty Adds (SFA): up to 25%;
- mono unsaturated fatty Adds (MUFA): preferably more than 40% and
- polyunsaturated fatty Adds (PUFA) : 20-35% induding said EPA and / or DHA.

In the preparation of the above dietary oil blend of the invention the source of said Eicosa Pentaenoic Acid (EPA) and / or Docosa Hexaeonoic Acid (DHA) can include fish oil, algae oil, marine mammals, sea fish and sea birds. Algae species grown in fermentors are also a good source of DHA. In the instance the EPA, DHA content in a particular batch extruded from fish / algae oil is found to be less then it can be concentrated by fractionation distillation including molecular distillation. The final desired composition is obtained to contain desired level of EPA and / or DHA and at the same time be heat stable for use as a cooking media.
The cooking oil source in the blend can include conventional Groundnut oil, Ricebran oil, Soyabean oil, Corn Oil, Palm oil, and mixtures thereof.
The blend can additionally incorporate other known additives to conventional dietary edible oils permitted antioxidants such as TBHQ, BHA, Tocopherol etc.
Subsequent to the selective blending of the various oils and the EPA / DHA fraction obtained from fish / algae oil the blended oil is refined and deodorized using standard refining procedures.
It is thus possible by way of the present invention to provide for selective heat stable dietary cooking oil composition containing the much desired EPA / DHA which would on one hand facilitate the effective heat stable application of the same as a cooking media and at the same time provide the desired health benefits in terms of atleast one of a) reducing the very low density lipoprotein (VLDL) and low density lipoprotein (LDL) to control cholesterol levels, b) elevating high density lipoprotein (HDL) another fat derivative to favour effective disposal of accumulated cholesterol, c) reduce triglycerides level and d) reduce the formation of triglycerides and reduce tendency of 'platelets' to dump and adhere to the blood vessels walls and related contraction of the blood vessels themselves.
The dietary oil composition of the invention is thus selective and demonstrates unexpected advantages in the selective blends of EPA / DHA in dietary oil formulations by way of meeting the required heat stability of cooking oil formulation and also imparting the required health benefits in its regular consumption as a form of a cooking media.
The details of the invention its objects and advantages are explained hereunder in greater detail in relation to the following non-limiting exemplary illustrations.
EXAMPLES:

To ascertain the stable constitution and heat stability of the dietary edible oil blend of the invention including the selective EPA and / or DHA, various blends of EPA / DHA sources (fish oil) were obtained in accordance with the invention with known varieties of Groundnut oils with permitted antioxidant. The oil / blends thereof as per Examples 1 to 5 were obtained and their respective fatty Acid constitution including the EPA and DHA levels are as detailed in TABLE - 1 hereunder: -
Table-I

To ascertain the heat stability of the above cooking oil formulations of the invention the selective compositions (Examples 1 to 5) containing EPA and DHA in the range of 5% to 13% were subjected to heating at 180°C(+).
The constitution of the dietary oils after heating as above were analyzed for the blends having 5% EPA / DHA(Example 1),7% EPA / DHA (Example 2),10% EPA / DHA(Example 3),11% EPA / DHA (Example 4) and 13% EPA / DHA (Example 5) so as to confirm the heat stability of the respective blends. The results obtained are illustrated hereunder in Tables II to VI.

Table II

Ex 1 : Oil blend containing about 5% EPA / DHA Ex IB: Heated for 3 mins at 180°C EX IB : Heated for 10 mins at 180°C
Table-III


Ex 2 : Oil blend containing about 7% EPA / DHA EX 2A : Heated for 3 mins at 180°C
Table-IV

Ex 3 : Oil blend containing about 10% EPA / DHA Ex 3A : Heated for 3 mins at 180°C
Table V


Ex 4 : Oil blending containing about 11% EPA / DHA from algae source Ex 4A : Heated for 5 minutes at 180°C
Table VI

Fatty Add Ex.5 Ex.5A
16:0 8.7 8.7
18:0 3.0 3.1
18:1 50.0 50.4
18:2 20.7 20.7
20:0 1.2 1.2
20:1 1.0 1.1
20:5 3.5 3.5
24:0 0.8 0.8
22:5 1.2 1.2
22:6 9.9 9.3
Ex 5 : Oil blending containing about 13% EPA / DHA from fish oil source Ex 5A : Heated for 5 minutes at 180°C
To further confirm the constitutional stability of the dietary oil blend of the invention polar material content was analyzed following American Official Analytical Method. AOCS Cd 20-91. Air was incorporated during heating by a magnetic stirrer. The fatty Acid constitution of the selective compositions of Examples 4 and 5 before and after heating were determined by gas liquid chromatography and the results are illustrated in Tables VII and VIII hereunder: -
Table VII
Percentage Polar Compound of about 11% EPA / DHA from Algae source obtained following the above procedure of American Oil Chemists Society (AOCS Cd-20-91)

Percentage of Polar Compound
As per procedure of American Oil Chemists Society (AOCS Cd - 20-91

EX4 EX 4 A
0.41 0.46
Ex 4 : Percentage Polar Compound of about 11% EPA / DHA from algae source Ex : 4A : Heated for 5 minutes at 180°C
Table VIII
Percentage Polar Compound of about 13% EPA / DHA from fish oil source obtained following the above procedure of American Oil Chemists Society (AOCS Cd-20-91)
Percentage of Polar Compound as per procedure of American Oil Chemists Society (AOCS Cd-20-91)

EX.5 Ex. 5A
9.3 10.2
Ex. 5 : Percentage Polar Compound of about 13% EPA / DHA from fish oil Source Ex. 5A : Heated for 5 minutes at 180°C.
As would be evident from the results in Tablets n, m, IV, V, VI, VII and VIII above there was no noticeable change in the fatty Acid constitution before heating (Example 1,2,3,4,5.) and after heating (Examples 1A, IB, 2A, 3A, 4A, 5A,) of the blends containing upto 13% EPA / DHA of the invention.
The problem of stability of EPA / DHA at ambient condition apart from at higher temperature of a cooking media and its surprising and selective heat stability in the dietary oil blend of the invention having effective amount of EPA / DHA is furttier demonstrated in the following Table IX.

Table-IX


Patty Acid Composition of Oils before and after heating at 180°C, 200°C and 220°C

As apparent from Table IX above four different varieties of dietary oil blends having EPA / DHA in combination with Groundnut oil were subjected to stability tests on its fatty Acid constitution at ambient and at higher temperatures at 180°C, 200°C and 220oC.The results are shown in detail in the same Table DC.
As would be dearly apparent from the above Table IX while the unblended 100% EPA / DHA showed instability even at ambient temperature (demonstrated by the increased values of unknown constituents in the analysis) revealing its problem in use as a cooking oil media which requires stability even at higher temperatures of 180°C+, surprisingly and unexpectedly the combination of the EPA / DHA with Groundnut oil achieved desired heat stability not only at ambient temperature but even at higher temperature of 180°C+.
It is thus dearly evident from the above that a selective blend of EPA / DHA in dietary edible cooking oil formulations surprisingly provide for the desired heat stability of such blend of EPA / DHA in cooking oil for daily use apart from being safe and healthy for the entire family to consume.
Importantly, the present invention provides for a dietary edible cooking oil formulation which by way of a selective and / or synergistic incorporation of EPA / DHA would enable bringing down the VLDL, and LDL in cerum lipid and thereby reduce the cholesterol level. Further the selective blend is suggested to elevate HDL level, which again favour in redudng excess accumulation of cholesterol in cerum lipid. Added to the above, the selected dietary edible oil composition is supposed to reduce triglyceride level in the cerum lipid as also reduce the tendency of the platelets to clump and adhere to blood vessel wall and avoid problems of the blood vessel / wall contracting and favour health benefits on regular consumption.
The oil formulation of the invention is thus directed to serve the long time need for suitable media to favour incorporation of selective therapeutically active amounts of highly unstable EPA / DHA and in providing a dietary therapeutic edible oil, which apart from serving as a suitable heat stable cooking media would also take care of cardiac problems and would serve as a safe and healthy dietary cooking media.

We Claim:
1. Heat stable dietary edible oil comprising a selective amount of 0.5 to 20% of at least one of Eicosa Pentaenoic Add (EPA) and Docosa Hexaenoic Add (DHA) maintained heat stable in combination with edible oil constituents / ingredients.
2. Heat stable dietary edible oil as daimed in daim 1 comprising a selective amount of 0.5 to 10% of EPA and / or DHA in combination with edible oil constituents / ingredients.
3. Heat stable dietary edible oil darned in anyone of daims 1 or 2 comprising fatty Add distribution of:
saturated fatty Adds (SFA): up to 25%;
mono unsaturated fatty Adds (MUFA): preferably more than 40% and polyunsaturated fatty Adds (PUFA) : 20-35% induding said selective EPA and / or DHA.
4. Heat stable dietary edible oil as daimed in daim 3 wherein said PUFA fatty preferably comprise linoletc Acid (C 18:2 n-6), Alfa-linolenic Acid (ALNA) (C 18:3 n-3) and also indude EPA/ DHA (C 20:5 n-3 and C 22:6 n-3).
5. Heat stable dietary edible oil as daimed in anyone of daims 1 to 4 wherein the source of said Eicosa Pentaenoic Add (EPA) and / or Docosa Hexaenoic Add (DHA) is selected from fish oil, algae oil, marine mammals, sea fish and sea birds, Algae spedes grown fermentors.
6. Heat stable dietary edible oil as daimed in anyone of daims 1 to 5 wherein the cooking oil source in the blend comprise conventional edible oil sources preferably Groundnut oil, Ricebran oil. Soyabean oil. Com Oil, Palm oil, and mixtures thereof induding hydrogenated fractionated and interesterified oils.
7. Heat stable dietary edible oil as daimed in anyone of daims 1 to 6 comprising additives to conventional dietary edible oils preferably permitted antioxidants, preferably TBHQ, BHA, Tcopherol.
8. A process of manufacture of the EPA / DHA fortified heat stable dietary oil comprising:
incorporating a selective amount of 0.5 to 20% preferably 0.5 to 10% of EPA and / or DHA in edible oil constituents / ingredients such as to maintain desired heat stability of the blend as a cooking media.

9. A process of manufacture of the EPA / DHA fortified heat stable dietary oil as
claimed in claim 8 comprising: incorporating selectively a fatty Acid distribution
of:
saturated fatty Acids (SFA): upto 25%;
mono unsaturated fatty Adds (MUFA): preferably more than 40%; and
polyunsaturated fatty Adds (PUFA) : 20-35% induding said EPA and / or
DHA.
10. A process of manufacture of the EPA / DHA fortified heat stable dietary oil as claimed in anyone of claims 8 or 9 wherein the source of said Eicosa Pentaenoic Add (EPA) and / or Docosa Hexaenoic Add (DHA) used is selected from fish oil, algae oil, marine mammals, sea fish, sea birds and Algae spedes grown in fermentors as a source of DHA.
11. A process of manufacture of the EPA / DHA fortified heat stable dietary oil as daimed in anyone of daims 8 to 10 comprising concentrating by fractionation distillation induding molecular distillation the EPA, DHA content in a batch extruded from fish / algae oil.
12. A process of manufacture of the EPA / DHA fortified heat stable dietary oil as daimed in anyone of daims 8 to 11 wherein the final desired composition is obtained to contain desired level of EPA and / or DHA and at the same time be heat stable for use as a cooking media.
13. A process of manufacture of the EPA / DHA fortified heat stable dietary oil as daimed in anyone of daims 8 to 12 wherein the cooking oil source in the blend comprise conventional edible oil sources preferably selected from Groundnut oil, Ricebran oil, Soyabean oil. Com Oil, Palm oil, and mixtures thereof.
14. A process of manufacture of the EPA / DHA fortified heat stable dietary oil as daimed in anyone of daims 8 to 13 comprising incorporating additionally in the blend other known additives to conventional dietary edible oils preferably permitted antioxidants preferably selected from TBHQ, BHA, Tocopherol.
15. A process of manufacture of the EPA / DHA fortified heat stable dietary oil as daimed in anyone of daims 8 to 14 wherein subsequent to the selective blending of the various oils and the EPA / DHA fraction obtained from fish / algae oil the blended oil is refined and deodorized using standard refining procedures.

16. A method of treating coronary conditions following any one of a) redudng the
very low density lipoprotein (VLOL) and low density lipoprotein (LOL) to control
cholesterol levels, b) elevating high density lipoprotein (HDL) another fat
derivative to favour effective disposal of accumulated cholesterol, c) reduce
triglycerides level and d) reduce the formation of triglycerides and reduce
tendency of 'platelets' to dump and adhere to the blood vessels walls and related
contraction of the blood vessels themselves comprising:
regular consumption of the heat stable dietary edible oil comprising a selective amount of 0.5 to 20% of at least one of Eicosa Pentaenoic Add (EPA) and Docosa Hexaenoic Add (DHA) maintained heat stable in combination with edible oil constituents / ingredients as daimed in anyone of daims 1 to 7.
17. Use of the heat stable dietary edible oil as daimed in anyone of daims 1 to 7 as a therapeutically benefldal cooking media.
18. Heat stable dietary edible oil induding EPA / DHA and its manner of manufacture substantially as herein described and illustrated with reference to the accompanying examples.
Dated this 11th day of December 2004
Anjan Sen Of Anjan Sen & Assodates (Applicant's Agent)