Classifications

• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight

Definitions

• Beta-hydroxybutyrate (a C4 ketone) and its salts, esters, and combinations thereof have become increasingly common in the marketplace for the ability to increase blood BHB levels, promote increases in cognitive function, and an array of benefits that may benefit diseased individuals.
• the heart, brain and kidney are the three organs with the highest activity of enzymes utilizing ketone bodies (Ardawi and Newsholme 1982). For instance, studies have shown an improvement in the neurological status of a newborn with pyruvate carboxylase deficiency during treatment with triheptanoin (C7 ketone) (Mochel et al 2005; Roe and Mochel 2006).
• a therapeutically effective amount of one or more C5 ketone body, pharmaceutically acceptable salt, ester, chelate thereof, and/or combinations thereof may be administered to increase mental and/or physical performance levels in a subject.
• Administration may increase and/or maintain ketosis, increase blood ketone levels, increase and/or maintain weight loss, increase fat loss, improve body composition, increase strength (e.g., power, muscle mass), increase energy, and/or increase cognitive health (e.g., cognitive function, memory, focus, motor function associated with age or disease related declines, etc), glucose tolerance, maintain and/or reduce blood glucose levels, reduce or inhibit progression of symptoms of traumatic brain injury, and/or reduce or inhibit progression of cognitive decline symptoms.
• the pharmaceutically effective amount of C-5 ketone bodies may be administered to healthy and/or not healthy (e.g., with diseases such as obesity, etc. and/or disorders) individuals.
• the methods described aid Kreb cycle function and/or anaplerosis in a subject being treated with the described compositions.
• the C5 ketone body is B-ketopentanoate (beta-ketopentanoate).
• the C5 ketone body may be administered with one or more additional compounds (beta-hydroxybutyrates, fatty acids, triglycerides, vitamins, minerals, amino acids, proteins, etc.).
• the C5 ketone body may be administered with one or more pharmaceutically acceptable binders and/or carriers.
• compositions that include the C5 ketone body may be administered to treat of the diseases, conditions, and/or symptoms thereof as described herein.
• approximately 1 to approximately 50 g of the C5 ketone body, pharmaceutically acceptable salt, ester, chelate thereof, and/or combinations thereof may be administered (e.g., orally) to an individual.
• Figure 1 illustrates the metabolism of C5 ketones in their racemic mixture and dissociated into their respective isoforms.
• Figure 2 illustrates C4 ketogenesis and C5 ketogenesis in the liver. Numbers refer to the following enzymes: 3 -ketoacyl-CoA thiolase (1); HMG-CoA synthase (2); HMG-CoA lyase (3); and beta-hydroxybutyrate dehydrogenase(4). The figure also shows the link between propionyl- CoA and the CAC via anaplerosis.
• Figure 3 illustrates the metabolism of triheptanoin into C5 ketone bodies 3- hydroxypentanoate (BHP) and beta-ketopentanoate (BKP), which ultimately get transported out of the mitochondria.
• Figure 4 shows a graph of blood glucose level with BKP administration.
• Figure 5 shows a graph of blood ketone level with BHP administration.
• Figure 6 shows a graph of visual analog scales (VAS) of well-being with BKP administration.
• Figure 7 shows a graph of VAS of energy with BKP administration.
• Figure 8 shows a graph of VAS of focus with BKP administration.
• a C5 composition that includes one or more C5 ketone bodies may be administered to a subject in a therapeutically effective amount.
• the C5 composition may be orally administered.
• the C5 composition may include one or more additional compounds.
• a therapeutically effective amount of one or more C5 ketone body, pharmaceutically acceptable salt, ester, chelate thereof, and/or combinations thereof may be administered to increase mental and/or physical performance levels in a subject.
• Administration may increase and/or maintain ketosis, increase blood ketone levels, increase and/or maintain weight loss, increase fat loss, improve body composition, increase strength (e.g., power, muscle mass), increase energy, and/or increase cognitive health (e.g., cognitive function, memory, focus, motor function associated with age or disease related declines, etc), glucose tolerance, maintain and/or reduce blood glucose levels, reduce or inhibit progression of symptoms of traumatic brain injury, and/or reduce or inhibit progression of cognitive decline symptoms.
• compositions and methods may be utilized for the treatment and/or prevention of one or more of obesity; diabetes; metabolic syndrome; Alzheimer's disease; Chronic Fatigue Syndrome (CFS); aging; fibromyalgia; dyslipidemia; hypercholesterolemia; dyslipidemia; Parkinson's disease; migraines; Traumatic Brain Injury (TBI); Attention Deficit Disorder (ADD)/ Attend on Deficit Hyperactivity Disorder (ADHD); Cancer, such as for example, glioblastoma; Cardiovascular Disease (CVD)/ Coronary Artery Disease (CAD); Chronic Pain; neuralgia; depression; amyotrophic lateral sclerosis (ALS); epilepsy; Insufficient Cellular Energy (ICE); mitochondrial dysfunction; and/or combinations thereof.
• Various methods may increasing mental and/or physical performance levels.
• C5 ketone body may include 3-hydroxypentanoate (BHP) and/or beta-ketopentanoate (BKP).
• C5 ketones may include C5 ketone bodies that are unbound in their "free acid” state.
• C5 ketones may include C5 ketone salts (e.g. sodium, calcium, magnesium, etc.), esters (e.g. glycerol), chelates (e.g. amino acids), or any other appropriate chemical variant with C5 ketones attached.
• C5 ketones can be in combination with other compounds, including other carbon length ketones themselves.
• the C5 ketone may include C5 ketones such as beta- hydroxypentanoate (BHP) [R,S, & RS isoforms] and/or 3-ketopentanoate (BKP) (also known as 3 -hydroxy valerate and 3 -ketovalerate).
• the C5 ketone bodies may include, but are not limited to, P-hydroxypentanoate (BHP) or a ester thereof; P- ketopentanoate (BKP) or a ester thereof; P-hydroxypentanoate or a chelate thereof; P- ketopentanoate or a chelate thereof.
• one or more of the C5 ketone bodies may include ester derivatives including alkyl ester derivatives, such as methyl, ethyl, propyl, butyl, hexyl, etc.
• Ester derivatives may include as one or more esters, such as mono-, di-, tri-, oligo-, and/or polyesters.
• the C5 ketone bodies may include esters such as mono-esters of ethanol, mono-ester of 1 -propanol, mono-ester of 1,2-propanediol, di-ester of 1,2-propanediol, mono-ester of 1,3 -propanediol, di-ester of 1,3-propanediol, mono-ester of S-, R-, or S — R- 1,3 -butanediol, di-ester of S-, R-, or S — R- 1,3 -butanediol, mono-ester of glycerin, mono-ester, di-ester of glycerin, tri-ester of glycerin, and/or combinations thereof.
• esters such as mono-esters of ethanol, mono-ester of 1 -propanol, mono-ester of 1,2-propanediol, di-ester of 1,2-propanedio
• C5 ketone bodies may be naturally formed in the liver from the partial oxidation of odd chain fatty acids (e.g. C-7, heaptanoic acid, like macadamia nut oil).
• C5 ketones have been shown to occur in trace amounts in human plasma and most plants. They are derived from the oxidation in liver of the R-moiety of R,S-l,3-pentanediol, a potential nutrient. Whether administered by bolus or constant infusion, the two substrates are interconverted and rapidly metabolized in an animal model.
• C5 ketone bodies may be interconverted by mitochondrial BHB dehydrogenase.
• C5 ketone bodies may be at least partially converted to propionyl- CoA (which is anaplerotic).
• Peripheral tissues may have a high capacity to utilize exogenous C5 ketone bodies, especially heart, kidney, and brain, which have high activities of 3-oxoacid-CoA transferase.
• C5 ketone bodies may provide a unique benefit in promoting increases in mental and physical performance, aiding Kreb cycle function, and contributing as a unique aide in various diseased populations (e.g., obesity, diabetes, cancer, cardiovascular disease, epilepsy, Alzheimer's, Parkinson's, etc.) and anaplerotic scenarios.
• C5 ketone bodies may improve weight loss/fat loss.
• the C5 composition may include approximately 0.5 g to approximately 50 g of one or more C5 ketone bodies.
• the C5 ketone bodies of the C5 composition may include one or more C5 ketone bodies such as BHP and/or BKP.
• a C5 ketone body may include salts, esters, chelates, complexes, other appropriate forms, and/or combinations thereof of one or more C5 ketone bodies.
• a C5 ketone body may include salts, esters, chelates, complexes, other appropriate forms, and/or combinations thereof of BHP.
• a C5 ketone body may include salts, esters, chelates, complexes, other appropriate forms, and/or combinations thereof of BKP.
• a C5 ketone body may include free C5 ketone bodies such as free BHP and/or free BKP.
• the C5 ketone bodies may include racemic mixtures and/or enriched mixtures (e.g., one form may be predominant) to produce a predetermined effect during administration.
• the C5 ketones utilized in the methods and compositions may be provided in an isolated or purified form. Synthetic variants of the C5 ketones may be utilized, either individually or in combination with other synthetic C5 ketone variants, or in combination with non-synthetic variants.
• the C5 composition may include C5 ketone body salts.
• the cation associated with the C5 ketone body salts may be any appropriate cation such as sodium, potassium, magnesium, calcium, zinc, selenium, chromium, other appropriate minerals, and/or combinations thereof.
• the cations may be chosen to produce a specific effect in the body.
• one or more of the cations in the C5 composition may operate in a similar manner as an electrolyte drink (e.g., by utilizing a predetermined amount of sodium, potassium, calcium, and/or magnesium).
• two or more, three or more, and/or four or more different C5 ketone body salts may be selected to produce a predetermined effect in the body (e.g., high initial spike in blood ketone levels, approximately even increase in blood ketone levels for a predetermined period of time such as 60 and/or 90 minutes, etc., a combination with low magnesium to reduce GI issues, a combination with relatively higher magnesium to facilitate sleep while maintaining C5 composition administration schedule(s), etc.).
• a predetermined effect in the body e.g., high initial spike in blood ketone levels, approximately even increase in blood ketone levels for a predetermined period of time such as 60 and/or 90 minutes, etc., a combination with low magnesium to reduce GI issues, a combination with relatively higher magnesium to facilitate sleep while maintaining C5 composition administration schedule(s), etc.
• the C5 composition may include isomers and/or polymers of C5 ketone bodies, as appropriate.
• a pharmaceutically effective amount of the C5 composition including one or more C5 ketone bodies may be administered in an individual to promote and/or maintain ketosis, cause weight loss and/or manage weight, and/or increase blood ketone levels.
• approximately 0.1 g to approximately 50 g of BHP and/or BKP may be administered to a subject.
• approximately 0.1 g to approximately 15 g of BHP and/or BKP may be administered to an individual.
• approximately 1 g to approximately 10 g of BHP and/or BKP may be administered, for example, once a day to 5 times a day.
• less than 3 g of C5 ketone bodies may be administered to the subject (e.g., approximately 0.1 to approximately 3 g of BHP and/or BKP).
• the administration may cause weight loss and/or maintenance; elevated beta-hydroxybutyrate levels in the blood; elevated, reduced, and/or maintenance of blood ketone levels; induction and/or maintenance of ketosis; and/or reduction; improve mental acuity; improve focus; improve energy; improve cognitive function; reduce traumatic brain injury; improve diabetes; improve glucose tolerance; decrease blood glucose levels; reduce neurological disorders and/or symptoms thereof; improve cancer and/or symptoms thereof; improve inflammatory conditions; suppressing appetite; improve symptoms associated with aging; provide anti-glycation affects; improve epilepsy and/or symptoms thereof; improve depression and/or symptoms thereof; improve performance; improve strength; increase muscle mass; increase fat loss; improve body composition; improve energy; improve focus; improve cognitive function; improve mood and/or well-being; and/or combinations thereof.
• the C5 composition that includes one or more C5 ketone bodies may be administered in healthy and not healthy individuals (e.g., individuals with diseases and/or disorders).
• blood ketone levels and/or blood glucose levels may be reduced and/or maintained within a predetermined range when a pharmaceutically effective amount of the C5 composition is administered.
• a health of an individual e.g., strength, symptoms of disease, mental acuity, fasting glucose levels, etc.
• the C5 compositions comprising one or more C5- ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, as the active ingredient.
• the compositions described can also be in the form of a pharmaceutical composition comprising one or more pharmaceutically acceptable carriers described herein.
• the compounds and compositions of the disclosure can be used to treat, alleviate, inhibit or prevent the diseases and conditions further described herein. Further, the compounds and compositions of the disclosure can be used for increasing mental and/or physical performance levels in a subject or for aiding in weight loss.
• the C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 50 grams.
• the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof concentration is from about 1 gram to about 40 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 30 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 20 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 10 grams.
• the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 10 grams to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 20 grams to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 30 grams to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 40 grams to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is about 10 grams.
• the C5 composition may include one or more additional compounds.
• the C5 composition may include and/or may be administered with, and/or coupled to a compound such as an amino acid.
• the C5 composition may include one or more amino acids such as leucine, taurine, purine, lysine, arginine, histidine, ornithine, creatine, agmatine, citrulline and/or combinations thereof.
• Administration of C5 ketone bodies with amino acids may reduce the intake of cations associated with salts (e.g., which may inhibit side effects associated with administration) and/or allow administration of another compound that has health benefits (e.g., administration of some amino acid may promote smooth muscle growth and/or cell repair).
• approximately 0.5 g to approximately 10 g of amino acid may be administered with one or more C5 ketone bodies.
• less than approximately 50 g of C5 ketone body may be administered with less than approximately 60 mg of an amino acid, such as leucine, may be administered daily.
• approximately 0.5 g to approximately 2 g of an amino acid, such as leucine may be administered with a C5 ketone body.
• approximately the composition administered may include approximately 0.1 to approximately 7 g C5 ketone body and approximately 1-3 g of leucine.
• the C5 ketone body and the leucine may be a mixture; administered separately and proximate in timing; a complex, and/or administered in any other appropriate manner.
• the C5 composition may include C5 ketone body salt and one other slower blood ketone elevating C5 ketone body.
• an individual may be administered a first weight amount of BHP salt and/or BKP salt and a second weight amount of ester of C5 ketone body and/or a polymer of C5 ketone body.
• the first amount and the second amount may be different or the same.
• the C5 composition may include one or more betahydroxybutyrates.
• R-beta-hydroxybutyrate may be administered to manage glucose tolerance, reducing fasting glucose levels, and/or maintain and/or promote ketosis (e.g., maintain and/or increase blood ketone levels).
• ketosis e.g., maintain and/or increase blood ketone levels.
• C5 composition may include one or more additional compounds that may or may not be capable of independently increasing ketone levels, maintaining ketone levels, inducing ketosis, and/or maintaining ketosis.
• additional compounds capable of independently increasing blood ketone levels may include short chain fatty acids (e.g., fatty acid with between 2 carbons than 6 carbons), short chain triglycerides (e.g., triglycerides with less than 6 carbons), medium chain fatty acids (e.g., fatty acid with 6-12 carbons), medium chain triglycerides (e.g., triglycerides with 7-12 carbons), long chain fatty acids (e.g., fatty acids with more than 12 carbons), long chain triglycerides (e.g., triglycerides with more than 12 carbons), and/or combinations thereof.
• short chain fatty acids e.g., fatty acid with between 2 carbons than 6 carbons
• short chain triglycerides e.g., triglycerides with less than 6 carbons
• medium chain fatty acids e.g., fatty acid with 6-12 carbons
• medium chain triglycerides e.g.,
• short chain fatty acids and/or triglycerides may include acetate, propionate, and/or butyrate.
• Medium chain fatty acids and/or triglycerides may include lauric acid and/or coconut oil, coconut milk powder, fractionated coconut oil, isolated hexanoic acid, isolated octanoic acid, isolated decanoic acid, ethoxylated triglyceride, triglyceride derivatives thereof, aldehyde triglyceride derivatives thereof, monoglyceride derivatives thereof, diglyceride derivatives thereof, triglyceride derivatives thereof, and/or alkyl esters thereof.
• Long chain fatty acids and/or triglycerides may include dairy products and/or palm oil.
• a composition including C5 ketone bodies and an additional compound that is independently capable of increasing ketone levels may increase ketone levels greater than merely the capability of each component individually (e.g., greater than an additive increase).
• the C5 composition may include C-5 ketone bodies and/or and an additional compound independently capable of increasing ketone levels such as caffeine.
• the C5 composition may include C5 ketone bodies, R-beta-hydroxybutyrate, and/or and an additional compound independently capable of increasing ketone levels such as caffeine.
• the composition may include approximately 0.5 mg to approximately 50 g of C5 ketone bodies (e.g., BHP salt and/or BKP salt) and caffeine.
• the C5 composition may include approximately 0.5 mg to approximately 15 g of C5 ketone bodies and less than approximately 500 mg of caffeine.
• the C5 composition may include approximately approximately 0.5 mg to approximately 15 g of C5 ketone bodies and approximately 5 mg to approximately 500 mg of caffeine.
• the composition may include approximately 0.5 mg to approximately 15 g of C5 ketone bodies and approximately 10 mg to approximately 150 mg of caffeine.
• the composition may include approximately 0.5 mg to approximately 15 g of C5 ketone bodies and approximately 10 mg to approximately 50 mg of caffeine.
• the C5 composition with C5 ketone bodies may increase and or maintain ketosis, weight loss, fat loss, and/or mental acuity.
• the C5 composition with caffeine may increase mental processes (e.g., acuity including cognitive functioning, mood, energy, alertness, focus, performance, effects of aging, etc.); improve and/or maintain body composition; function as a therapeutic for one or more of the described conditions or disorders (e.g., treat neurological disorders); and/or combinations thereof.
• the C5 composition may include an additional compound independently capable of increasing ketone levels, such as 1,3,7,9-Tetramethyluric acid (commercially available as theacrine; and/or commerically available as TeaCrine® from Compound Solutions, California, USA).
• the composition may include approximately 0.5 mg to approximately 15 g of C5 ketone bodies and less than approximately 500 mg of 1,3,7,9-Tetramethyluric acid.
• the C5 composition may include approximately 5 mg to approximately 15 g of C5 ketone bodies and less than approximately 500 mg of 1,3,7,9-Tetramethyluric acid.
• the C5 composition may include approximately 0.5 to approximately 50 g of C5 ketone bodies and 0.5 to 20 g of beta-hydroxybutyrate (e.g., free BHB, free RBHB, sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, etc.).
• beta-hydroxybutyrate e.g., free BHB, free RBHB, sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, etc.
• the combination of the C5 ketone bodies and the beta- hydroxybutyrate may provide unexpected increase in blood ketone levels when compared to the components individually and/or at least partially enter the Krebs cycle.
• the C5 composition may include one or more fatty acids, esters, or triglycerides.
• the C5 composition may include a short chain compound (e.g., short chain fatty acid and/or short chain triglyceride) may unexpectedly increase ketone concentrations in the blood more than the administration of similar amounts of C5 ketone bodies and medium chain compounds (e.g., short chain fatty acid and/or short chain triglyceride) and/or may increase ketone concentrations in the blood more than each component individually.
• a short chain compound e.g., short chain fatty acid and/or short chain triglyceride
• medium chain compounds e.g., short chain fatty acid and/or short chain triglyceride
• the C5 composition may include odd chain fatty acids.
• the administration of C5 compositions with odd chain fatty acids may increase C5 production in the liver.
• a pharmaceutically effective amount of C5 composition may include a pharmaceutically effective amount of long chain fatty acid and/or triglyceride.
• 0.1-50 g of C5 ketone bodies and 0.1 to 50 g of long chain fatty acid may be administered to an individual between 1-5 times a day.
• approximately 1 g to approximately 3 g of C5 ketone bodies and approximately 1 g of long chain fatty acid and/or triglyceride may be administered from once a day to approximately 5 times a day.
• C5 ketone bodies, short chain compound(s) (e.g., fatty acids and/or triglycerides, butyrate), and/or medium chain compound(s) (e.g., fatty acids and/or triglycerides) may be administered approximately simultaneously and/or sequentially to an individual.
• short chain compound(s) e.g., fatty acids and/or triglycerides, butyrate
• medium chain compound(s) e.g., fatty acids and/or triglycerides
• approximately 0.1g to approximately 50 g C5 ketone bodies, approximately 0.1g to approximately 50 g short chain triglyceride, and approximately 0.1g to approximately 50 g medium chain fatty acid such as lauric acid and/or coconut oil may be administered between 1-5 times a day.
• the C5 ketone bodies may include or be administered with one or more other compounds such as, but not limited to, amino acids, amino acid metabolites, proteins (e.g., dairy proteins such as whey and/or casein; vegan proteins such as pea protein and/or pumpkin protein; egg protein; meat derived proteins; any other appropriate protein; and/or combinations thereof), vitamins, minerals, herbs and/or extracts of herbs, coconut milk (e.g., powder), flavorings, colorings, binders, electrolytes, tetrahydrobiopeterin, nucleic acids, alpha-ketoglutaric acid, alpha lipoic acid, nutritional co-factors, beta-methyl- beta- hydroxybutyrate, arginine alpha-ketoglutarate, R-alpha lipoic acid, thiamine, NAD+, NADH, riboflavin, FAD+, FADH, riboflavin-5-phosphate, niacin, nicotinic acid,
• proteins e.g.,
• the C5 composition may include and/or be administered in a bone broth (e.g., powdered and/or in fluid form).
• the inclusion of bone broth may increase satiety and/or palatability.
• the bone broth and C5 ketone bodies may increase and/or facilitate maintenance of ketosis.
• C5 composition may include approximately 0.5 to approximately 50 g of C5 ketone bodies compounds and approximately 1 g to approximately 50 g of bone broth.
• C5 composition may include approximately 0.5 to approximately 20 g of C5 ketone bodies and approximately 1 g to approximately 30 g of bone broth.
• C5 composition may include approximately 0.5 to approximately C5 ketone bodies and approximately 1 g to approximately 10 g of bone broth.
• the C5 composition that includes bone broth may include additional compounds such as caffeine, vitamins, collagen peptides, etc.
• the C5 composition that includes bone broth may cause greater user satisfaction when compared with conventional bone broths (e.g., due to the pleasant saltiness provided by the C5 salts, ability to increase ketone delivery without increasing fat intake, the appetite suppressant of the C5 ketone bodies, etc.).
• administration of the C5 composition may improve and/or maintain health markers such as C-reactive protein and/or fasting glucose.
• Administration of the C5 composition may decrease inflammation (e.g., as shown by C-reactive protein levels).
• Administration of C5 composition may decrease fasting glucose.
• administration of approximately 0.5 to 50 g of C5 ketone bodies may cause a reduction in and/or maintain a low fasting glucose.
• the C5 composition may include and/or be administered with one or more other of the described additional compounds to decrease glucose levels and/or sensitivity.
• a berberine such as dihydroberberine, may cause reduce and/or maintain low fasting glucose.
• the C5 composition may include a long-acting component and/or be long-acting.
• the delivery of C5 ketone bodies may be slower than a digestion of a C5 ketone body salts.
• the composition may include a C5 ketone body salt and a long-acting C5 ketone body form (e.g., polymer, ester, coated and/or processed form to provide slow release).
• a first dose(s) may include at least one non-long-acting form of C5 ketone body and a second dose(s) may include at least one long-acting form of C5 ketone body.
• the first dose(s) may be administered to cause a predetermined health impact and the second dose(s) may be administered to maintain the caused predetermined health impact.
• users may select the appropriate dose based on user preference and/or properties (e.g., a user on a ketogenic diet may chose the second dose since the user may already be in ketosis).
• the C5 composition may include one or more amino acids (e.g., leucine), caffeine, flavors, vitamins, minerals, herb extracts (e.g., extract of Uncaria tomentosa), and/or pharmaceutically acceptable binders (e.g., fluid and/or solid binders).
• the C5 composition may include bone broth.
• the C5 composition may include fatty acids, esters, or triglycerides (e.g., short chain, long chain, and/or medium chain).
• the C5 composition may include 0.5 to 3g of C5 ketone bodies, caffeine, and/or fatty acids, esters, and/or triglycerides (e.g., medium, short, and/or long chain).
• the C5 composition may include one or more NAD, ketone esters, Sweeteners (e.g., natural and/or synthetic), Flavors, Vitamins, CMED 100, AcAc, Caffeine, MCTs, SCFA, Creatine, Protein, Glucose, Glutamine, Electrolytes (e.g., additionally and/or from the salt of the C5 ketone bodies and/or beta-hydroxybutyrate), Pyruvate, Lactate, and/or combinations thereof.
• NAD ketone esters
• Sweeteners e.g., natural and/or synthetic
• Flavors e.g., natural and/or synthetic
• Vitamins e.g., CMED 100, AcAc, Caffeine, MCTs, SCFA, Creatine, Protein, Glucose, Glutamine
• Electrolytes e.g., additionally and/or from the salt of the C5 ketone bodies and/or beta-hydroxybutyrate
• Pyruvate
• the C5 composition may include cannabidiol (CBD) with or without R-beta-hydroxybutyrate.
• CBD cannabidiol
• the C5 composition may include approximately 0.5 to approximately 50 g of C5 ketone bodies and approximately 5 mg to approximately 300 mg CBD.
• the C5 composition may include approximately 0.5 to approximately 50 g of C5 ketone bodies, approximately 0.5 to approximately 20 g of beta-hydroxybutyrate, and approximately 5 mg to approximately 300 mg CBD.
• ADD Attention Deficit Hyperactivity Disorder
• CVD Cardiovascular Disease
• CAD Coronary Artery Disease
• Chronic Pain Pain
• neuralgia depression
• amyotrophic lateral sclerosis ALS
• epilepsy Insufficient Cellular Energy (ICE) and mitochondrial dysfunction
• administering a therapeutically effective amount of a C5 composition that includes one or more C5 ketone bodies, or pharmaceutically acceptable salt, ester, or chelate thereof to a subject (e.g., a mammal and/or a human).
• administration of a pharmaceutically acceptable amount of the C5 composition may decrease the neurological decline and/or the symptoms of neurological decline related to age and/or disease (e.g., brain function, energy, focus, mood, motor control, etc.)
• administration of a pharmaceutically acceptable amount of the C5 composition may reduce inflammation.
• C5 ketones have potential to work directly on the mitochondria, therefore, in some implementations, the C5 ketones and related methods described by this disclosure are useful for treating mitochondrial dysfunction. As such, C5 ketones are particularly useful in treating cancers that result from mitochondrial dysfunction, such as, for example, glioblastoma.
• aspects of the present disclosure may also be directed to methods for increasing blood ketone levels in a subject, comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, 3-hydroxypentanoate (BHP).
• a C5 ketone body or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, 3-hydroxypentanoate (BHP).
• a further aspect of the present disclosure may be directed to methods for decreasing blood glucose levels in a subject, comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, 3 -ketopentanoate (BKP).
• a C5 ketone body or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, 3 -ketopentanoate (BKP).
• aspects of the present disclosure are also directed to methods for increasing mental and/or physical performance levels which involve administering a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, or pharmaceutical compositions of the present disclosure, to a subject, preferably a mammal, and most preferably a human.
• the C5 ketone body is(3- ketopentanoate.
• the mental performance level being increased may be a measure of wellbeing and/or focus.
• the physical performance level being increased may be a measure of energy.
• the subject disclosure provides methods for aiding in weight loss in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
• the subject disclosure provides methods for lowering exertion during exercise in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 ketone body (e.g., 3 -ketopentanoate), or pharmaceutically acceptable salt, ester, or chelate thereof.
• a C5 ketone body e.g., 3 -ketopentanoate
• the exercise is moderate intensity exercise and in other implementations, the exercise is high intensity exercise.
• Moderate intensity exercise includes, for example, running, cycling, rowing, circuit training, and yogo.
• High intensity exercise includes, for example, sprinting, hockey, soccer, baseball, football, basketball, resistance training and boxing.
• the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 40 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 30 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 20 grams.
• the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 10 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 10 grams to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 20 grams to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 30 grams to about 50 grams.
• the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 40 grams to about 50 grams. In some implementations, the C5 ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is about 10 grams.
• Administration can be locally (confined to an area of body) and/or systemically in the subject. It may be desirable to administer the C5 ketones, or pharmaceutical compositions comprising same, locally to the area in need of treatment.
• This method of administration may be achieved by, for example, and not by way of limitation, local infusion, topical application, by injection, by catheter, or by means of an implant (e.g., a porous membrane).
• Administration may also be orally, such as but not limited to, by way of pills, capsules, liquid, vapors, or powders.
• aspects of this disclosure can provide more than two active ingredient components in the mixtures of compositions herein disclosed.
• the disclosed methods can comprise the simultaneous or separate administration of multiple active ingredients.
• implementations may further include the administration of a third, fourth, etc. active ingredient, wherein the third, fourth, etc. active ingredient is administered separately, but at the same time as the other active ingredients, or hours or days after the first administration of active ingredients.
• the C5 ketones, or pharmaceutical composition containing them can be delivered in a controlled release system.
• Such methods may include the use of a pump for administration (e.g., use of an intravenous drip).
• compositions of the invention may also be utilized in pharmaceutically acceptable compositions in the methods provided herein. It would also be understood by a skilled artisan how to use the compositions described herein for therapeutic purposes without undue experimentation based on the teachings provided throughout the specification.
• the amount of active ingredients or pharmaceutical compounds of the invention which will be effective in the treatment, inhibition and/or prevention of the diseases and/or conditions described herein can be determined by standard clinical techniques. Additionally, in vitro assays may be employed to help identify optimal dosage ranges. The precise dose to be utilized will also depend on the route of administration, and the seriousness of the disease or condition, and should also be decided according to the sound medical judgment of the clinician and each patient's individual circumstances.
• the specific therapeutically effective dosage level for any particular patient will depend upon a variety of factors including: the type and degree of the response to be achieved; the specific composition and other agent(s), if any, employed; the age, weight, general health, sex and diet of the patient; the time of administration, route of administration, and rate of excretion of the composition; the duration of the treatment; other drugs used in combination or coincidental with the composition; and any other factors well known in the medical arts.
• Effective dosages may also be extrapolated from dose-response curves derived from in vitro or animal model testing systems.
• the mental performance level being increased is a measure of well-being and/or focus.
• the physical performance level being increased is energy.
• the subject disclosure provides methods for increasing blood ketone levels in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof
• the C5 ketone body is 3-hydroxypentanoate.
• the subject disclosure provides methods for treating and/or preventing one or more of obesity, diabetes, metabolic syndrome, Alzheimer's disease, Chronic Fatigue Syndrome (CFS), aging, fibromyalgia, dyslipidemia, hypercholesterolemia, dyslipidemia, Parkinson's disease, migraines, Traumatic Brain Injury (TBI), Attention Deficit Disorder (ADD)/ Attend on Deficit Hyperactivity Disorder (ADHD), Cancer, Cardiovascular Disease (CVD)/ Coronary Artery Disease (CAD), Chronic Pain, neuralgia, depression, amyotrophic lateral sclerosis (ALS), epilepsy, Insufficient Cellular Energy (ICE) and mitochondrial dysfunction in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
• CFS Chronic Fatigue Syndrome
• fibromyalgia dyslipidemia
• hypercholesterolemia dyslipidemia
• Parkinson's disease migraines
• Traumatic Brain Injury (TBI) Attention Deficit Disorder
• the subject disclosure provides methods for decreasing blood glucose levels and/or increasing BHB levels in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof
• the C5 ketone body is 3 -ketopentanoate.
• the subject disclosure provides methods for aiding in weight loss in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
• the subject disclosure provides methods for lowering exertion during exercise in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
• compositions comprising a therapeutically effective amount of C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
• Example 1 BHP and BKP effects on subject blood glucose and ketone levels; and subject well-being, energy and focus
• VAS visual analog scales
• Table 4 VAS of Energy following BHP and BKP administration.
• Table 5 VAS of Focus foilowing BHP and BKP administration.
• Example 2 C5 ketone administration as a method to lower exertion during exercise
• the amount of C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, and other carbon length ketone, individually may or may not be therapeutically effective.

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• 2023
  • 2023-04-20 WO PCT/US2023/019245 patent/WO2023211755A1/en not_active Ceased
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