DESC:A Nutraceutical Composition for Lactose Intolerance
Technical Field of the Invention
The invention relates to a formula for ready to mix powder supplement that can be consumed with milk and milk based products by kids and adults who have lactose intolerance. The ready to mix powder blend of beta-galactosidase enzyme and herbs, to be mixed with dairy or non-dairy based protein, amino acids, vitamins and minerals which contain lactose in significant amount and may pose health issue in lactose intolerant individuals.
Background of the Invention
Lactose intolerance is a condition that develops when the body has difficulty digesting lactose containing products, such as dairy products. The inability to hydrolyze lactose into its component sugars results in bloating, gastrointestinal discomfort, cramping, diarrhea, nausea, or flatulence after the ingestion of lactose-containing products in people having lactose intolerance. In severe cases, malabsorption resulting from lactose intolerance may result in anorexia and weight loss. Kids and adults with lactose intolerance generally lack vitamin D and calcium in their body due to restricted intake of milk and other dairy products containing lactose.
Dairy products are generally defined as products produced from milk. They are usually high-energy-yielding food products. Dairy products are commonly consumed in European, Middle Eastern and Indian cuisine.
Enzymes in the gastrointestinal tract have been known to aid in the digestion of food both from plants and animal origin. Some people lack effective amounts of enzymes to digest various comestibles. Some humans are considered lactose intolerant because their bodies do not produce an effective amount of ß-galactosidase, also known as lactase, to convert lactose, a disaccharide carbohydrate found in milk produced by various animals, into glucose and galactose. Lactose is a milk sugar and like most sugars, it is broken down by enzymes in the intestinal tract so that it can be utilized as an energy source. When the intestine does not contain lactase or lactase is not present in good quantity, then lactose intolerance can occur.
People use various methods to have relief from the symptoms of lactose intolerance. One such method is ingesting lactose-reduced or lactose-free dairy products. Currently market is flooded with lactose free milk or plant-based milk for lactose intolerance and plant protein-based health supplement powder.
The present invention provides a unique powder supplement that can be consumed with regular milk by the lactose intolerant kids/adults. The compositions of the invention contain herbs and enzyme ß-galactosidase, also known as lactase and other pharmaceutically acceptable excipients which can be added to a health supplement containing vitamins, minerals, dairy or non-dairy proteins. The health supplement would provide immense relief and confidence for consumers looking for a health supplement which will allow them to have benefits of milk consumption.
Summary of the Invention
In one general aspect, the present invention provides a nutraceutical ready to mix powder composition that comprises herbs and beta-galactosidase enzyme for an individuals with lactose intolerance to be consumed with any dairy/non -dairy based health drink which contain lactose.
In an embodiment of the above aspect, the protein may be from the group consisting of protein from single or multiple sources selected from milk protein or plant protein and combination thereof.
In another embodiment of the above aspect, the herbs are selected from a category of phytonutrients like saponin, terpenes and other embodiment from Nagarmotha (Cyperus rotundus), Ashwangandha (Withania somnifera), Tulsi (Ocimum sanctum) and combination thereof to increase the efficacy of enzymes to support lactose digestion.
In another embodiment of the above aspect, beta-galactosidase (lactase) enzyme is present in an amount sufficient to breakdown the total lactose content in a serving of dairy, dairy based , or combination with non-dairy based product formulation. A beta-galactosidase (lactase) can be taken from any bacterial, fungal, yeast, animal or plant sources.
In another embodiment, the non- dairy product may be plant or any plant based product.
In another embodiment, the dairy product may be milk or any milk based product.

In another embodiment, the dairy based product is derived from milk that contains lactose.
Detailed Description of the Invention
The invention relates to a ready to mix powder composition that can be added to milk or milk based formulation which can be a consumed by a lactose intolerant individual with no or minimal health issues. The invention is characterized by the steps for formulation of a dairy or non-dairy based health drink along with several nutritional benefits like added vitamins, minerals and herbs.
The ready to mix powder contains optimized amount of lactase enzyme and herbs. The amount of enzyme and herbs is optimized to break lactose into glucose and galactose. The optimized amount of the enzyme and the herbs is such that it is able to breakdown total lactose in a serving of 100-250 mL of milk as well as the total lactose in the powder health supplement formulation. The herbs are selected from the group consisting of Cyperus Rotundas, Ashwagandha and Tulsi for overall lactose intolerance support. This provides a safe milk based health drink formulation for lactose intolerance kids and adults.
Herbs are natural substances with wide range of health attributes. In India, most of milk is converted into traditional dairy products which are consumed by people of all age groups. Traditional dairy products can act as potent carrier for the herbs which can add functional attributes to the product thereby improving consumers’ wellbeing. Apart from general benefits, herbs like Cyperus, Ashwagandha and Tulsi also play a supporting role in potentiating the beta-galactosidase enzyme activity.
The herb Cyperus rotundus (Ayurvedic name: Nagarmotha) is a cosmopolitan weed plant found in almost every corner of the tropical, subtropical, and temperate regions. C. rotundus contains several phytochemical constituents of various classes like fat, gum resins, carbohydrates, essential oils alkaloids, saponins, flavonoids, terpenoids, mono-and sesquiterpenes, albuminous matters, fibers, and ash. It is a widely used plant in traditional systems of medicine, especially in Ayurveda and folk systems around the world, for its useful remedial properties in indigestion, constipation, dysentery, abdominal distention, cholera, skin diseases, diabetes, furuncle infections, sprains and bruises, fever and stomach ache, etc. (Kumari et al., IJP, 2021; Vol. 8(6): 232-24; Peerzada et al. Journal of Ethnopharmacology Volume 174, 4 November 2015, Pages 540-560). Saponin content in herbs is known to have below effect on Lactase enzyme (Kayukawa et al. Food Chemistry 303(1–2):125388). Basically saponins increases the ß-glycosidase catalytic activity. The affinity of ß-galactosidase and its substrate is increased by saponin.
Ashwagandha and Tulsi are known to content high level of saponin and thus addition of these helps to support the enzyme activity. Other than this the polyphenol and terpenes present in this extract also has positive role for bioavailability, bioaccessibility and Starch digestion (Rocchetti et al, Antioxidants 2020, 9, 306; doi:10.3390/antiox9040306).
The ready to mix powder compositions of the invention are prepared by mixing the measured quantities of the enzyme and herbal extracts and other pharmaceutically acceptable excipients to provide a ready to mix powder composition. The composition can be added to any dairy or non-dairy based powder, liquid drink like milk or milk based to make a lactose free drink
The ready to mix powder compositions of the invention provides beta-galactosidase enzyme and herbs to digest lactose present in dairy or non-dairy based food/health/nutraceutical supplements.

When it is desired that the consumer wants to take milk and milk derived products in the diet, the ready to mix powder composition can be taken before,with or immediately after taking the meal. The ready to mix formulation developed with herb and enzyme combination can be consumed safely with 100-250mL milk serving without worrying about indigestion, flatulence or bloating due to lactose intolerance. The composition has been invented to help lactose intolerance people take the benefits of nutrition provided by milk and milk-based products. The herbs present in the composition provide phytonutrient benefits along with their supporting role to augment the beta-galactosidase activity
Examples
The present invention will be further described having reference to the following examples, by way of illustration only. All the components were weighed according to the compositions defined below were blended to provide ready to mix powder compositions to be added or blended into a final dairy or non- dairy based formulation to support lactose intolerance
Composition 1
S. No Product Name Weight %
1 Cyperus Rotundus 0.07
2 Ashwagandha extract 0.07
3 Holy basil extract 0.07
4 Beta-galactosidase 0.10
Total 0.310

Composition 2
S. No Product Name Weight %
1 Cyperus Rotundus 0.03
2 Ashwagandha extract 0.02
3 Holy basil extract 0.02
4 Beta-galactosidase 0.10
Total 0.17

Composition 3
S. No Product Name Weight %
1 Cyperus Rotundus 0.07
2 Ashwagandha extract 0.02
3 Holy basil extract 0.02
4 Beta-galactosidase 0.12
Total 0.23

Composition 4
S. No Product Name Weight %
1 Cyperus Rotundus 0.07
2 Ashwagandha extract 0.02
3 Holy basil extract 0.02
4 Beta-galactosidase 0.25
Total 0.360

Composition 5
S. No Product Name Weight %
1 Cyperus Rotundus 0.03
2 Ashwagandha extract 0.03
3 Holy basil extract 0.03
4 Beta-galactosidase 0.20
Total 0.290

Composition 6
S. No Product Name Weight %
1 Cyperus Rotundus 0.03
2 Ashwagandha extract 0.03
3 Holy basil extract 0.03
4 Beta-galactosidase 0.30
Total 0.390

Example 1
A blend containing the beta-galactoside enzyme and herbs was mixed with protein supplement powder (30 grams) and 250mL of milk and tested for the presence of lactose. The result showed that the content of lactose was below limit of detection (BLD). As per FSSAI, for a product to be called as lactose free, the product should not have more than 50 mg of lactose per 100g/100mL of the product.
,CLAIMS:. A nutraceutical ready to mix powder composition that comprises herbs and beta-galactosidase enzyme for an individuals with lactose intolerance to be consumed with any dairy/non -dairy based health drink which contain lactose.
2. The nutraceutical ready to mix powder composition as claimed in claim 1, wherein the protein is selected from the group consisting of protein from single or multiple sources selected from milk protein or plant protein and combination thereof.
3. The nutraceutical ready to mix powder composition as claimed in claim 1, wherein the herbs are selected from a category of phytonutrients like saponin, terpenes and other embodiment from Nagarmotha (Cyperus rotundus), Ashwangandha (Withania somnifera), Tulsi (Ocimum sanctum) and combination thereof.
4. The nutraceutical ready to mix powder composition as claimed in claim 1, wherein the beta-galactosidase (lactase) enzyme is present in an amount sufficient to breakdown the total lactose content in a serving of dairy, dairy based , or combination with non-dairy based product formulation.
5. The nutraceutical ready to mix powder composition as claimed in claim 1, wherein the beta-galactosidase (lactase) is taken from bacterial, fungal, yeast, animal or plant sources.
6. The nutraceutical ready to mix powder composition as claimed in claim 1, wherein the non- dairy product may be plant or any plant based product.
7. The nutraceutical ready to mix powder composition as claimed in claim 1, wherein the dairy product is milk or any milk based product.
8. The nutraceutical ready to mix powder composition as claimed in claim 1, wherein the dairy based product is derived from milk that contains lactose.