Claims:We Claim,

1. A phytochemical formulation to improve the gut health, the formulation comprises:
a. dietary fiber rich fraction isolated from Curcuma longa at a concentration of 90%-95%;
b. curcuminoids rich fraction isolated from rhizome of Curcuma longa at a concentration of 2% to 5%; and
c. Ferula asafoeitida extract at a concentration of 1% to 3%
Wherein curcuminoids rich fraction and Ferula asafoeitida extract are encapsulated onto dietary fiber to form a uniform polar-non-polar complex.

2. The formulation as claimed in claim 1, wherein curcuminoids rich fraction and Ferula asafoeitida extract forms a complex with dietary fiber rich fraction from Curcuma longa

3. The formulation as claimed in claim 1, wherein the polar-non-polar complex penetrate the cell membrane and reach the blood plasma level to improve the bioavailability.

4. The formulation as claimed in claim 1, wherein the formulation is useful in powder form of administration.

5. The formulation as claimed in claim 1, wherein the formulation improved gut microbiota by increasing 27.16% of fecal bifidobacteria count in human.

6. The formulation as claimed in claim 1, wherein the formulation improved gut microbiota by increasing 23.97% of fecal lactobacilli count in human.

7. The formulation as claimed in claim 1, wherein the formulation reduced inflammatory bowel disease symptoms in human.
, Description:Preamble to the Description

[0001] The following specification describes the invention and the manner in which it is to be performed:
DESCRIPTION OF THE INVENTION
Technical field of the invention
[0002] The present invention relates to a phytochemical formulation for improvement of gut health. More particularly, the invention relates to a unique phytochemical formulation to maintain a healthy gut micro biota with controlling the inflammatory bowel disease symptoms.
Background of the invention
[0003] Health of gut or gastrointestinal tract (GI tract) is extremely important for overall well-being of the body. Since gut transports food from the mouth to the stomach, converts it into absorbable nutrients and stored energy, and shuttles waste back out of the body, it is also called as second brain of the body. The gut starts from the mouth and end at anus wherein this entire journey of food from mouth and anus determines how healthy a body is. Inflammation anywhere along the digestive tract disrupts this normal process and the main organs food goes through between mouth and anus include esophagus, stomach, small intestine, and large intestine.
[0004] Gut is full of trillions of bacteria that not only help to process food, but that also help body maintains homeostasis and overall well-being. This microflora may be unique to an individual and is primarily determined by the kind of food, a person consumes and how disciplined life he/she lives in terms of kind of food, sugar/fat levels, exercise, sleep time, medication, and stress levels. Further, research also indicates that babies delivered vaginally grow up to have more diverse microflora than those delivered via C-section, as they get exposed to different bacteria as they pass through the birth canal. Breastfeeding has also been shown to foster beneficial gut bacteria.
[0005] Gut microflora is key to many aspects of human health including immune system, metabolism and other neuro behavioral traits. The gut microbes are essential for the fermentation of non-digestible substrates like dietary fibers and endogenous intestinal mucus where this fermentation supports the growth of specialist microbes that produce short chain fatty acids (SCFAs) and gases, including acetate, propionate, and butyrate. Therefore, it is important to develop lifestyle habits that lead to good gut health.
[0006] One of the most complex implications of poor gut heath is inflammatory bowel disease (IBD), an umbrella term used to describe disorders that involve chronic inflammation of the digestive tract. Mainly there are 2 types of IBDs, Ulcerative colitis, involving inflammation and sores (ulcers) along the superficial lining of your large intestine (colon) and rectum and Chron's disease, characterized by inflammation of the lining of digestive tract, which often can involve the deeper layers of the digestive tract. IBD generally is considered to be an autoimmune disease, but research suggests that the chronic inflammation may not be due to the immune system attacking the body itself, but it is a result of the immune system attacking a harmless virus, bacteria, or food in the gut, causing inflammation that leads to bowel injury.
[0007] Inflammatory bowel disease symptoms vary, depending on the severity of inflammation and where it occurs. Symptoms may range from mild to severe. General signs and symptoms that are common to both Crohn's disease and ulcerative colitis include, diarrhea, fatigue, abdominal pain, stomach cramps, blood in your stool, reduced appetite, weight loss and anemia due to blood loss etc.
[0008] Anti-inflammatory drugs are often the first step in the treatment of inflammatory bowel disease as they decrease inflammation of the digestive tract. The medication generally includes immune suppressants, antidiarrheal drugs and laxatives that affect gut microflora and ecosystem adversely and have several side effects.
[0009] The control of inflammatory bowel disease directly requires improvement and maintenance of gut health. Various types of medicines are available in the market today that claim to improve gut health. However, they do more harm to the body. There is a need to have a formulation that can naturally build and maintain gut health and reduce chances of developing inflammatory bowel disease.
Summary of the invention
[0010] In order to overcome the drawbacks of the existing prior art, the present invention discloses a formulation for maintaining gut health in humans.
[0011] The present invention discloses a phytochemical formulation comprising dietary fibers and standardized curcuminoids from Curcuma longa and Ferula asafoeitida extract. The standardized curcuminoids from Curcuma longa and Ferula asafoeitida extract are encapsulated in dietary fibers of turmeric forming a uniform matrix. The phytochemical formulation comprises dietary fibers obtained from Curcuma longa at a concentration of 90%-95%, standardized curcuminoids obtained from Curcuma longa at a concentration of 2% to 5% and Ferula asafoeitida extract at a concentration of 1% to 3%.
[0012] The formulation of the present invention is a complex of polar and non-polar molecules prepared using the PNS technology. Further, the complex prepared by the PNS technology improves the functional properties of the formulation, stability of the biomolecules, enhance the bio efficacy and controls release of the specific molecule of interest at the targeted tissues.
[0013] The formulation is prepared in powered form using the spray drying technology to enhance the efficacy of the formulation due to high surface area. Curcuminoids and Ferula asafoeitida extract are encapsulated on the dietary fibers of turmeric to form a firm and uniform complex and the encapsulation is confirmed by various analysis.
[0014] The safety and efficacy of the formulation of the present invention is analyzed for management of gut health and intestinal microflora in humans. The results indicated that the phytochemical formulation showed 27.16% increase in fecal bifidobacteria count and 23.97% increase in fecal lactobacillithus confirming the efficacy in improvement of gastrointestinal and gut health in humans without inducing any adverse effects in humans.
[0015] The formulation is natural, safe, and effective in improving the gut health and in maintaining gut microbiota in humans.
Brief Description of the drawings
[0016] FIG 1 tabulates the composition of the phytochemical formulation according to an embodiment of the invention.
[0017] FIG 2 illustrates the results of UPLC and GC-MS analysis of dietary fibers and the formulation of the present invention.
[0018] FIG 3 illustrates the results of the (FT-IR) spectra of dietary fibers and the formulation.
Detailed description of the invention
[0019] In order to more clearly and concisely describe and point out the subject matter of the claimed invention, the following definitions are provided for specific terms, which are used in the following written description.
[0020] The term “Gut” refers to gastrointestinal tract, which starts from the mouth to the anus which includes all the organs of the digestive system in humans and other animals.
[0021] The term “Gut microflora” refers to gut microbiome or the microorganisms living in the intestine.
[0022] The term “Inflammatory Bowel Disease (IBD)” refers disorders that involve chronic inflammation of your digestive tract.
[0023] The term “PNS Technology” refers to Polar-Nonpolar Sandwich (PNS) Technology, used to increase the bio efficacy of nutraceutical ingredients.
[0024] The term “Phytochemical” refers to the chemicals produced by plants through primary or secondary metabolism.
[0025] The present invention relates to a phytochemical formulation to improve the gut health. The formulation comprises the natural ingredients in processed form for maintaining a healthy gut microbiota by controlling the Inflammatory Bowel Disease (IBD) symptoms.
[0026] The formulation of the present invention comprises dietary fibers from Curcuma longa, standardized curcuminoids from Curcuma longa and non-volatile Ferula asafoeitida extract formed as a uniform matrix.
[0027] Curcuma longa, commonly termed as turmeric has been traditionally used in various medicines systems across the globe to manage many physical ailments. Similarly, Asafoetida is the dried latex i.e., gum oleoresin exuded from the rhizome or tap root of several species of Ferula perennial herbs, part of Umbelliferae family.
[0028] The phytochemical formulation of the present invention has been developed comprising dietary fiber, curcuminoids from Curcuma Longa rhizomes and non-volatile components of Ferula Asafoeitida using Polar-Nonpolar Sandwiching (PNS) Technology. PNS Technology is used to increase the bio-efficacy of nutraceutical ingredients.
[0029] FIG 1 tabulates the composition of the phytochemical formulation according to an embodiment of the invention. The formulation of the present invention comprises dietary fibers and curcuminoids from Curcuma longa and Ferula asafoeitida extract. The phytochemical formulation comprises dietary fibers obtained from Curcuma longa at a concentration of 90%-95%, standardized curcuminoids obtained from Curcuma longa at a concentration of 2% to 5% and Ferula asafoeitida extract at a concentration of 1% to 3%.
[0030] The presence of dietary fibers from Curcuma longa acts as a polar group and Ferula asafoeitida extract acts as a non-polar group and curcuminoids isolated from Curcuma longa is sandwiched between these polar and nonpolar matrices.
[0031] The formulation forms a polar-non-polar sandwich complex, in which the active ingredients namely polar i.e., water soluble and non-polar i.e., oil soluble components penetrate the cell membrane and reach the blood plasma level. As a result, the efficacy and bioavailability of the formulation is increased.
[0032] The phytochemical formulation is prepared in which the bioactive ingredients curcuminoids and Ferula asafoeitida extract are encapsulated on to the turmeric fiber matrix. The turmeric fiber acts as a suitable carrier for encapsulating the bioactive ingredients to improve the efficacy.
[0033] The dietary fibers in the formulation influences in the gastrointestinal physiological functions and gut health of the host because of their physiochemical properties and capabilities of fermentation in the gut. The dietary fibers are complex carbohydrates containing of both soluble dietary fibers and insoluble dietary fibers. The soluble dietary fibers are fermented by assuring species of gut bacteria, prominent to physiologically active derivatives whereas the insoluble dietary fibers have significant bulking properties. The dietary fibers are degraded to produce short-chain fatty acids (SCFAs) by intestinal bacteria, which expand gastrointestinal health by stimulating the expression of porcine host defense peptides and altering the gut microbiota. The dietary fibers acts as prebiotic by specifically enhancing beneficial gut bacteria and thus improving human healthiness by its physical influence in the gut and improves the gut function.
[0034] The dietary fibers from Curcuma longa are a modified cell wall component of turmeric and is considered as a suitable carrier to encapsulate bioactive components such as curcuminoids and Ferula asafoeitida extract. In the formulation of the present invention, the curcuminoids and Ferula asafoeitida extract are encapsulated in the dietary fibers of Curcuma longa.
[0035] The formulation of the present invention is prepared using the PNS technology in which polar and non-polar molecules are formed as a complex. Further, the complex prepared by the PNS technology improves the functional properties of the formulation, stability of the biomolecules, enhance the bio efficacy and controls release of the specific molecule of interest at the targeted tissues.
[0036] The formulation is prepared in encapsulated form and is in powder form, which is prepared by spray drying. The powdered form of the encapsulated formulation increases the surface area thus improving the activity of the biomolecules used in the formulation.
[0037] The encapsulation of curcuminoids and Ferula asafoeitida extract on dietary fibers is confirmed by analysis of the formulation using Ultra Performance Liquid Chromatography (UPLC).
[0038] The mobile phase consists of 40% tetrahydrofuran and 60% water with 1% citric acid. The detection is carried out in an isocratic flow at a wavelength of 420 nm using a photodiode array (PDA) detector. The elution is carried out by isocratic method with 1 mL/min flow rate. The volatile oil is hydro-distilled from GHP for 6 h using Clevenger apparatus and dried over anhydrous sodium sulfate and stored in a refrigerator (8 ± 2 °C). The volatile oil is subjected to gas chromatography–mass spectrometry (GC–MS) analysis using Brucker 436-GC, couple with SCION TQMS by Rtx-624 fused silica column with 60 m column length and 0.25 mm internal diameter. The column temperature is maintained initially at 50 °C and gradually increased to a rate of 10 °C per minute till to attain 230 °C. Helium gas is used as a carrier gas at 1 mL/min of flow rate with constant pressure as 228 kPa.
[0039] FIG 2 illustrates the results of UPLC and GC-MS analysis of dietary fibers and the formulation of the present invention. The results indicated that presence of curcumin as depicted in FIG 2a. The GC-MS analysis of volatile oil of the formulation showed the presence of 2-mercapto-3,4-dimethyl-2,3-dihydrothiophene, n-propyl sec-butyl disulfide, 1,2-dithiolane, disulfide bis(1-methylpropyl), 1,3-dithiane, 2,2-bis(methylthio) propane and 1-(1-propen-1-yl)-2-(2-thiophen-3-yl) disulfide as depicted in FIG 2b. The presence of these compounds confirms the encapsulation of curcuminoids and Ferula asafoeitida extract on dietary fibers.
[0040] Fourier transform infrared (FT-IR) spectra of dietary fibers and the formulation are recorded by JASCO FT/IR-460 plus instrument in the range of 400–4000 cm-1 with 32 scans per sample using the grounded and blended samples with KBr in a ratio of sample/KBr at 1:4. The surface morphology of the dietary fibers, before and after encapsulation of bioactive compounds is determined using scanning electron microscopy (SEM). Elemental analysis is carried out by using Energy-dispersive X-ray spectroscopy (EDS) unit attached with SEM. The Samples are placed in aluminum stubs using double-sided carbon tape and sputter coated with a fine layer of gold using a sputter gold coater. All samples are examined using an accelerating voltage of 30 kV.
[0041] FIG 3 illustrates the results of the (FT-IR) spectra of dietary fibers and the formulation. The FT-IR spectra of dietary fibers and the formulation are elucidated in FIG. 3a and 3b respectively. In both the spectra, in the region of 3010–3653 cm-1, the broadened absorption band distinctive to the –OH stretching is observed and attributed to O-H stretching of hydrogen bound to the hydroxyl groups originating mainly from cellulose and hemicelluloses. The bands at 2854 and 2923 cm-1 are due to C-H stretching vibrations, which represented the presence of the typical structure of polysaccharide compounds. The prominent band of C-O-C pyranose ring skeletal vibration stretching around 1020 cm-1 observed in both spectra indicate the presence of xylans and is associated with hemi-celluloses, which confirmed that xyloglucans are strongly bound to dietary fibers and the intense band at this wavenumber proves high cellulose content in the formulation. The peak at 1633 cm-1 corresponded to bending or stretching aromatic hydrocarbons of lignin, which is one more main component of dietary nanofibers. In addition, the absorption band at 1155 cm-1 is contributed to the stretching of C-O groups of C-O-C aliphatic esters. In the spectrum of the formulation the band at 1428 cm-1 indicates the olefin bending vibration of the C=C group bound to the benzene ring which is present in curcumin as depicted in the FIG 3b. The spectrum exhibited weak to medium intensity bands in the region 626 to 730 cm-1 due to the asymmetric and symmetric C-S stretching vibration due to the presence of more number of sulfur containing compounds which are present in Ferula asafoeitida extract.
[0042] The characterization of the formulation confirms the encapsulation of curcuminoids and Ferula asafoeitida extract on dietary fibers of Curcuma longa.
[0043] The formulation of the present invention in analyzed for the management of gut health and intestinal microflora in human.
[0044] The following examples are offered to illustrate various aspects of the invention. However, the examples are not intended to limit or define the scope of the invention in any manner.
Example 1: The effect of the formulation in the management of gut health in human.
[0045] The safety and efficacy of the formulation of the present invention is analyzed for management of gut health and intestinal microflora in humans. A randomized, double-blind, placebo-controlled study is conducted in 30 humans out of which 20 are males and 10 are females, with ages ranging from 22 to 55 years after informed consent and evaluation of inclusion criteria. The effect of the formulation is analyzed on bifidobacteria and lactobacilli that are the indicators for gut health. The results indicated that the phytochemical formulation of the present invention showed 27.16% increase in fecal bifidobacteria count from screening stage to end of study, whereas the placebo group showed slight increase as 7.14%, Furthermore, the inter group analysis also showed a statistically significant p value (0.00026) based on the paired t-test. The formulation of the present invention also showed a significant result for fecal lactobacilli, which showed 23.97% increase in fecal lactobacilli count from the screening to end of study, whereas placebo group showed slight increase as 7.02%. In addition, the inter group analysis also showed a statistically significant p value (0.00067) based on the paired t-test. These results revealed that the phytochemical formulation is effective for improvement of gastrointestinal and gut health in humans.
[0046] Further, the formulation of the present invention did not show any significant change in lipid profile such as total cholesterol, triglycerides, HDL-C, LDL-C and VLDL, however, which has a tendency to decrease the levels of total cholesterol as3.90%, HDL-C as -18.37% and VLDL as -1.62%, due to the presence of dietary fibers in the formulation. However, the placebo group showed increase in total cholesterol as 0.64%, in triglycerides as 43.21% and in VLDL as 43.17%, which are also demonstrated the beneficial effect of the formulation over lipid profile, which is helpful in gastrointestinal and gut related problems and disorders.
[0047] The formulation of the present invention also exhibited significant reduction in Gastrointestinal Symptom Rating Scale (GSRS) with mean change reduction recorded as -28.57% between the study period, whereas the placebo showed increase in mean changes as 27.27%. There was statistically significant p value observed between the formulation and placebo study group based upon the paired t-test, which indicates an improvement in symptoms of gut health due to the administration of the formulation of the present invention. The changes in stool frequency assessed by BSS, the analysis of changes in BSS indicated positive stool changes in treatment group without inducing any adverse effects. This indicates the efficacy of the formulation in improvement of gut health in humans.
[0048] The formulation of the present invention includes spices, herbs and plant derived phytochemicals having the scientific superiority of low toxicity and superior bio efficacy. As the formulation is derived from the natural ingredients, it is safe for consumption without inducing any adverse effects on gut microflora.
[0049] The formulation of the present invention prepared by spray drying with improved characteristics such as bulk density is safe and effective in improvement of gut health micro biota by controlling the inflammatory bowel disease symptoms.