Patent Application
20200129580
The present invention relates generally to nutritional supplement compositions. More specifically, the present invention relates to a supportive blend of ingredients for blood glucose control and liver health support, particularly in weight loss compositions and methods.
The liver is an important organ that carries out many functions including blood detoxification, protein production, and production of factors involved in digestion and metabolism. It both stores and produces glucose—the preferred energy source for most vertebrate cell types—depending on the need. Blood glucose levels typically increase with feeding and decrease with exercise and fasting and are tightly controlled and held within a narrow range mainly by two opposing hormones: insulin and glucagon. Many disease states are associated with high levels of blood glucose. Therefore it is often desirable to control, by lowering or blunting, increases in blood glucose levels and to protect liver health and function.
A composition is provided comprising Nigella sativa extract, Kaempferia parviflora extract, and Rosa canina extract.
In an embodiment of the invention, there is provided a method for controlling blood glucose levels using a composition comprising Nigella sativa extract, Kaempferia parviflora extract, and Rosa canina extract.
In another embodiment of the invention, there is provided a method for liver protection using a composition comprising Nigella sativa extract, Kaempferia parviflora extract, and Rosa canina extract.
In another embodiment of the invention, there is provided a method for controlling blood glucose levels and for liver protection using a composition comprising Nigella sativa extract, Kaempferia parviflora extract, and Rosa canina extract.
In some aspects, a composition comprising Nigella sativa extract, Kaempferia parviflora extract, and Rosa canina extract is used in conjunction with methods for weight loss.
Embodiments will now be described, by way of example only, with reference to the attached Figures, wherein:
As used herein, “blood glucose control” and like phrases are understood to refer to effects resulting in general lowering of high blood glucose levels, particularly non-fasted blood glucose levels.
As used herein, “improving liver health”, “supporting liver health”, and “promoting liver health” and like phrases are understood to refer to lowering markers of liver damage or improving liver function. The enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are commonly measured as clinical biomarkers of liver health, with increases in one or both indicative of liver damage. A lowering of one or both of AST and ALT is understood to relate to improving liver health and/or liver function.
Nigella sativa (also known as black caraway, black cumin, fennel flower, nigella, nutmeg flower, Roman coriander, and kalonji) is a flowering plant native to Asia. It is widely used throughout the world as a medicinal plant, particularly the seeds, for conditions such as asthma, hypertension, diabetes, and inflammation.
Kaempferia parviflora (also known as Thai black ginger, Thai ginseng, Black Turmeric, Black Galingale, and krachai dum) is an herbaceous plant native to Thailand mainly used as an aphrodisiac.
Rosa canina (also known as dog rose and rose hip) is a deciduous shrub native to Europe, Africa, and Asia. Traditional uses include arthritis, gallstones, gout, and colds.
The inventors believed that the combination of Nigella sativa, Kaempferia parviflora, and Rosa canina would have beneficial effects on obesity, aiding in weight loss, through likely synergistic mechanisms. The inventors conducted a study in mice. Surprisingly, the inventors found that the specific combination of Nigella sativa, Kaempferia parviflora, and Rosa canina tested failed to result in observed weight loss while showing reductions in non-fasted blood glucose levels and markers of liver damage.
For the inventive composition, clinically relevant daily doses (in humans) for each of the ingredients were chosen and commercially available extracts were used. For Nigella sativa, 900 mg of a powdered 100% water seed extract at a ratio of 12-16:1 was used. For Kaempferia parviflora, 100 mg of a powdered dried root ethanol/water extract at a ratio of 3-4:1 was used. For Rosa canina, 100 mg of an ethanol/water fruit extract was used (containing about 0.1% trans-tiliroside). The ratio of Nigella sativa:Kaempferia parviflora:Rosa canina was 9:1:1 for a total of 1.1 g of the inventive composition.
For testing of the inventive composition, the determined human doses were converted to equivalent doses for testing in mice. The mouse dosage (converted from the human dose) used was 200 mg/kg body weight at the same 9:1:1 ratio of Nigella sativa:Kaempferia parviflora:Rosa canina.
The mouse model used was the C57BL/6 DIO (Diet Induced Obesity) model. Three groups of 10 mice per group: NFD (normal fat diet), HFD (high fat diet), and HFD-Tx (high fat diet+200 mg/kg/day treatment). Mice were 16 weeks of age at the start of the study. The mice were acclimated for 14 days to the respective NFD or HFD diets after which time the HFD group was randomized and treatment was started. Non-fasted glucose was measured at 0, 10, and 31 days of treatment, while fasted blood glucose, and serum markers alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured at 42 days of treatment, at which time all mice were sacrificed. The overall experimental setup is shown in
While not wishing to be bound by any particular theory, the inventors believe that the combination of Nigella sativa, Kaempferia parviflora, and Rosa canina may be useful in methods of weight loss, including synergistic interactions enhancing some of the effects, while the relative proportions of the components in the composition may provide some degree of interference of some effects. Furthermore, without being bound by theory, the inventors believe that the specific compositions disclosed herein as used and tested may be useful as a supportive composition for blood glucose control and liver health/protection when used solely for that purpose or for general health, when used in combination with one or more other ingredients for weight loss, or in conjunction with ingredients for other protocols such as, for example, weight gain, weight maintenance, muscle gain, cardiovascular training, or endurance training.
More specifically, the inventors believe that when combined with ingredients used for weight loss, the composition of Nigella sativa, Kaempferia parviflora, and Rosa canina may enhance weight loss, or alternatively, not interfere with weight loss, while providing the benefits of controlling blood glucose levels and/or supporting liver health by offering liver protection. Such weight loss ingredients are known to those skilled in the art and include but are not limited to: caffeine, green tea extract, green coffee bean extract, bitter orange (synephrine), conjugated linoleic acid, L-carnitine, African mango, and hydroxycitric acid.
The compositions of the present invention may be administered by any suitable means, including orally, sublingually, intravenously and topically. The preferred dosage forms are oral, and include ingestion as a solid, pill, tablet, liquid tablet, caplet or capsule, in a powder form or powdered beverage mix, suspended in water or other liquid, or as a dietary gel, and may be taken by itself or incorporated into compositions that further comprise other ingredients, such as, but not limited to, weight loss ingredients, as described above, additional active ingredients and/or inactive ingredients, including solvents, diluents, suspension aids, thickening or emulsifying agents, sweeteners, flavorings, preservatives, solid binders, lubricants and the like, as suited to the particular dosage form desired.
The above-described embodiments are intended to be examples of the present invention and alterations and modifications may be effected thereto, by those of skill in the art. Such alterations and modifications are contemplated and do not take the compositions described outside of the scope of the invention. The scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.
All publications which are cited herein are hereby specifically incorporated by reference into the disclosure for the teachings for which they are cited.
