SYMBIOTIC SUPPLEMENT FORMULATION FOR IMPROVING INTESTINAL MICROBIOTA

Abstract

Described is a symbiotic formulation for the oral consumption of probiotics and prebiotics with an aqueous extract of roselle, with vitamins and proteins for humans. The invention belongs to the field of nutrition and has been developed to help to maintain a healthy digestive system by restoring and/or improving the intestinal microbiota. The purpose of the antioxidants and the synergic effect of the symbiotic formulation is to reduce the inflammatory process so as to facilitate the absorption of nutrients and thus improve the good nutritional state of people. An oral symbiotic formulation based on an aqueous roselle extract with encapsulated probiotics and which can contribute to the consumption of antioxidants of natural origin, the ingestion of proteins and micronutrients for re-establishing or improving the state of the intestinal microbiota, as well as the nutritional state of adults and older people, has not been found in the prior art.

Claims

1. A food supplement formulation to be administered orally in humans with a symbiotic effect to improve the nutritional state and to be used to maintain the intestinal microbiota characterized in that each 100 g comprises: a. A formulation encapsulated in a polymer matrix of sodium alginate for oral administration to adults of an aqueous extract of roselle of natural origin which contains: i. Aqueous extract of roselle (Hibiscus sabdariffa): 90 ml ii. Prebiotic (agave inulin): 40 g iii. Encapsulated probiotic mixture: 500 mg of probiotics: TABLE-US-00006 1. L. casei Min. 1.5 × 10 10 CFU 2. L. Rhamnosus Min. 5 × 10 9 CFU 3. L. lactis Min. 5 × 10 9 CFU 4. L. plantarum Min. 2.5 × 10 10 CFU 5. B. longum Min. 4 × 10 9 CFU iv. Protein: range 3.3g -20 g TABLE-US-00007 L-histidine   900-4000 mg L-tyrosine 766.66-4600 mg L-isoleucine 383.33-2300 mg L-leucine 766.66-4600 mg L-methionine 133.33-800 mg L-valine 383.33-2300 mg v. Caloric value: 200-267 kcal vi. Sodium: 70 mg vii. Potassium: <10 mg viii. Mixture of micronutrients: TABLE-US-00008  1. Vitamin B6 Min. 6.6 mg  2. Vitamin B12 Min. 6.6 mcg  3. Vitamin B2 Min. 5.6 mg  4. Vitamin B3 Min. 66.6 mg  5. Folic acid Min. 666.66 mg  6. Vitamin A Min. 3330 mg  7. Vitamin B5 Min. 23.33 mg  8. Vitamin B1 Min. 50 mg  9. Vitamin E Min. 33.33 IU 10. Vitamin K1 Min. 266.66 mcg 11. Vitamin D3 Min. 16.66 mg 12. Vitamin C Min. 200 mg 13. Vitamin H Min. 333.33 mcg ix. It may also contain up to 8 g of agar as a thickener. b. The formulation established in letter a may be presented as soft gelatin, syrup, soft gelatin capsules, powder, elixir, suspension, solution or beads.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0023] The details characteristic of the symbiotic supplement formulation for improving intestinal microbiota are set out clearly in the description that follows. The invention that has been developed consists of a symbiotic supplement in a gelatin formulation for oral administration to adults based on an aqueous extract of roselle (Hibiscus sabdariffa) of natural origin and contains a mixture of vitamins, proteins, probiotics and prebiotics.

[0024] The formulation has the potential to improve the nutritional state of people by providing a symbiotic effect that may help improve the diversity and quantity of intestinal microbiota; it may also facilitate the absorption of important compounds in the functioning and regulation of metabolism.

[0025] The aqueous extract of roselle has antioxidant properties as said extract has a high content of phenolic compounds. The antioxidant capacity of phenolic compounds is linked to mechanisms of action related to vasodilator, antithrombotic and anti-inflammatory properties. The traditional consumption of an infusion of H. sabdariffa is linked to various therapeutic properties such as the ability to absorb free radicals inhibiting, for example, LDL oxidation; to significantly improve blood pressure in pre-hypertensive and slightly hypertensive patients with type 2 diabetes.

[0026] The mixture of probiotics selected has the ability to restore the microbiota found naturally in adults. Said mixture of probiotics is encapsulated in a polymer matrix (sodium alginate) to improve the viability of the probiotics when passing through the digestive tract and in order that said probiotics are bioavailable in the small intestine. The aqueous extract of roselle gelatin contains high levels of prebiotics (agave inulin) to promote the growth of native microbiota and help ensure that the probiotics administered have significant viability levels. The purpose of this symbiotic effect is to restore the microbiota with a possible effect of enhancing the immune system, facilitating and improving nutrient absorption.

[0027] Until now, no substance that demonstrates undesirable side effects has been found and this formulation should therefore be used as suggested (once a day). It may also be used to maintain the intestinal microbiota.

[0028] Every 100 g of the formulation developed contains: [0029] A soft gelatin formulation for oral administration to adults of an aqueous extract of roselle of natural origin made up of: [0030] Aqueous extract of roselle (Hibiscus sabdariffa): 90 ml [0031] Prebiotic (agave inulin): 40 g [0032] Encapsulated probiotic mixture: 500 mg of probiotics

TABLE-US-00002 Microorganism Quantity L. casei Min. 1.5 × 10{circumflex over ( )}10 CFU L. rhamnosus Min. 5 × 10{circumflex over ( )}9 CFU L. lactis Min. 5 × 10{circumflex over ( )}9 CFU L. plantarum Min. 2.5 × 10{circumflex over ( )}10 CFU B. longum Min. 4 × 10{circumflex over ( )}9 CFU [0033] Protein: range 3.3 g to 20 g

TABLE-US-00003 L-histidine   900-5400 mg L-tyrosine 766.66-4600 mg L-isoleucine 383.33-2300 mg L-leucine 766.66-4600 mg L-methionine 133.33-800 mg L-valine 383.33-2300 mg [0034] Caloric value: 200 kcal [0035] Sodium: 70 mg [0036] Potassium: <10 mg [0037] Mixture of micronutrients:

TABLE-US-00004 Micronutrients Quantity Vitamin B6 Min. 6.6 mg Vitamin B12 Min. 6.6 mcg Vitamin B2 Min. 5.6 mg Vitamin B3 Min. 66.6 mg Folic acid Min. 666.66 mg Vitamin A Min. 3330 mg Vitamin B5 Min. 23.33 mg Vitamin B1 Min. 50 mg Vitamin E Min. 33.33 IU Vitamin K1 Min. 266.66 mcg Vitamin D3 Min. 16.66 mg Vitamin C Min. 200 mg Vitamin H Min. 333.33 mcg

[0038] This formulation may be presented as a food supplement and to facilitate consumption is presented as gelatin; the formulation above allows adequate absorption of the components in the digestive tract. Agar may also be used as a thickener. The formulation may be presented as a syrup, elixir, suspension or solution.

[0039] One of the problems presented by the formulations of the majority of supplements with probiotics is to ensure the bioavailability of said probiotics. In the formulation described, to protect the probiotics in an aerobic medium and guarantee their availability, said probiotics were encapsulated with sodium alginate to form spheres containing the probiotic mixture (L. casei, L. rhamnosus, L. lactis, L. plantarum, B. longum). A study carried out in a digestive system simulator demonstrated the protective effect of the polymer matrix of sodium alginate used in the formulation described on the encapsulated probiotics. Various mixtures of probiotics and various concentrations of the encapsulating solution were evaluated.

[0040] The study was carried out using a simulator of the microbiota of patients with an inflammatory process. Sample 1 was the formulation described without the mixture of probiotics being encapsulated; sample 2 corresponds to the formulation described when the mixture of probiotics was encapsulated with a solution of sodium alginate.

[0041] Both samples passed through the digestive system simulator and the colony-forming units (CFU) were counted when said CFUs reached the stomach and the small intestine. The table below shows the results.

TABLE-US-00005 Genus of prebiotic Quantity in Section in small Sample used stomach intestine Sample 1 Lactobacilllus spp 22 × 106 No CFUs Sample 1 Bifidobacterium ssp No CFUs No CFUs Sample 2 Lactobacilllus spp 22 × 104 CFU/g 1 × 104 CFU/g Sample 2 Bifidobacterium ssp  4 × 104 CFU/g 2 × 104 CFU/g

[0042] It can be seen that when the probiotics were not encapsulated, the viability of the microorganisms of the genus Bifidobacterium ssp is zero in the stomach; even when the microorganisms of the genus Lactobacilllus spp reach the stomach in a viable state, when the sample reaches the small intestine their viability is zero. The results for sample 2 demonstrate that both the microorganisms of the genus Bifidobacterium ssp and those of the genus Lactobacilllus spp reached the stomach and the small intestine in a viable state; the count in the small intestine is lower than in the stomach owing to the pH of the stomach which affects the encapsulating polymer matrix.

[0043] The alginate solution is a good encapsulant at the concentration used in sample 2. The results in the table above demonstrate that the formulation described allows the probiotics to be in a viable state in the small intestine, and therefore when ingested, said probiotics may be of assistance in re-establishing the intestinal microbiota.

[0044] Antioxidants are the largest group of active compounds in foodstuffs. The mechanisms of action of these compounds are to interrupt the propagation of the free radical chain by giving up hydrogen atoms, trapping oxygen molecules and/or chelating activity. These mechanisms are important for health as they control the quantity of free radicals; free radicals are linked to degenerative diseases, including cancer.

[0045] Various modifications to these definitions and/or implementations will be quite clear to people skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown in this document, but the widest possible scope should be granted thereto consistent with the following claims and the principles and novel characteristics described in this document.