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1. WO2020115765 - NOUVELLE COMPOSITION SYNERGIQUE COMPRENANT DES ACTIVATEURS DE SIRT1 ET D'AMPK POUR LE TRAITEMENT DU SYNDROME MÉTABOLIQUE

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AMENDED CLAIMS

received by the International Bureau on 22 May 2020 (22.05.2020)

1. A novel synergistic nutritional composition for treating metabolic syndrome comprising a therapeutic exogenous blend of Nl-methylnicotinamide chloride and stabilized oxaloacetate along with pharmaceutically acceptable excipients, wherein the Nl-methylnicotinamide chloride and the stabilized oxaloacetate are present in the ratio of 1:2 to 1:5.

2. The novel synergistic nutritional composition as claimed in claim 1, wherein the stabilized oxaloacetate is a homogenous premix of crystalline organic oxaloacetic acid and standardized ascorbic acid in the weight ratio of 1: 1 to 1:2.

3. The novel synergistic nutritional composition as claimed in claims 1 and 2, wherein the Nl-methylnicotinamide chloride to the crystalline organic oxaloacetic acid to the standardized ascorbic acid weight ratio ranges from 1 : 1 : 1 to 1:2:2.

4. The novel synergistic nutritional composition as claimed in claim 3, wherein the Nl-methylnicotinamide chloride is present in the range of 15% to 30% by weight of total composition.

5. The novel synergistic nutritional composition as claimed in claim 3, wherein the crystalline organic oxaloacetic acid is present in the range of 15 to 35% by weight of total composition.

6. The novel synergistic nutritional composition as claimed in claim 3, wherein the standardized ascorbic acid is present in the range of 25 to 50% by weight of total composition.

7. The novel synergistic nutritional composition as claimed in claim 6, wherein the standardized ascorbic acid comprises 10-250 mg of ascorbic acid.

8 The novel synergistic nutritional composition as claimed in claim 1, wherein the pharmaceutically acceptable excipients are selected from a diluent present in the range of 1-35%; a binder present in the range of 0.5- 5%; a lubricant present in the range of 0.5 to 5 %; a glidant present in the range of 0.5-5 %; an additive present in the range of 1-10%, by weight of the total composition..

9. A novel synergistic nutritional combination of N 1 -methylnicotinamide chloride and crystalline organic oxaloacetic acid and standardized ascorbic acid in the weight ratio of 1: 1.1 : 1.6.

10. The novel synergistic nutritional combination as claimed in claim 9, wherein the amount of N1 -methylnicotinamide chloride is 26 ± 0.5 %, the amount of crystalline organic oxaloacetic acid is 29 ± 0.5% and the amount of standardized ascorbic acid is 44 ± 0.5 % by weight of the combination.

11. The novel synergistic nutritional combination as claimed in claim 9, wherein the amount of N1 -methylnicotinamide chloride is 18 ± 0.5 %; the amount of oxaloacetic acid is 20 ± 0.5%, the amount of standardized ascorbic acid is 30 ± 0.5 % by weight of total composition.

12 The novel synergistic nutritional composition as claimed in claim 1, wherein an effective oral dosage is in the form of tablet or capsule or powder or granules or fine particles.

13. Use of the novel synergistic nutritional composition as claimed in claim 1, for treating metabolic syndrome related to obesity, weight gain, hyperlipidemia, coronary heart diseases, diabetes, hepatic and renal disorders.

14. The novel synergistic nutritional composition as claimed in claim 1, wherein the effective unit dose for oral administration is in the range of 10 mg to 500 mg.