Granted Patent
B2
US 12,186,297 · App. 17/394,649 · Granted Jan 7, 2025
Compositions and methods for increasing lean-to-fat mass ratio
Assignee:
AXCESS GLOBAL SCIENCES, LLC
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Abstract
Disclosed herein are “ketone body-HMB” or “KB-HMB” compositions including a combination of: (1) hydroxymethyl butyrate; (2) a ketone body component such as beta-hydroxybutyrate (BHB) and/or acetoacetate; and (3) optionally a dietetically or pharmaceutically acceptable carrier. Also disclosed herein are methods of using such compositions for producing desired physiological effects, such as fat loss, in a mammal. The compositions beneficially enhance fat loss through ketosis while also reducing or eliminating muscle wasting and/or promoting muscle formation.
Claims (34)
1. A composition comprising:
an exogenous ketone body component selected from the group consisting of beta-hydroxybutyrate (BHB) salts, BHB esters, beta-hydroxybutyric acid, and combinations thereof; and
exogenous hydroxymethyl butyrate (HMB),
wherein the composition includes a ratio of exogenous ketone body component to exogenous HMB from about 4.5:1 to about 2.5:1 so as to be effective to increase lean mass to fat mass ratio in a mammal.
2. The composition of claim 1 , wherein the exogenous ketone body component includes an exogenous BHB salt or ester.
3. The composition of claim 1 , further comprising one or more of 1,3-butanediol, acetoacetate salt, acetoacetate ester, acetoacetic acid, or an exogenous fatty acid or an ester thereof.
4. The composition of claim 3 , wherein the exogenous fatty acid or ester thereof is a medium chain fatty acid or ester thereof, or a short chain fatty acid or ester thereof.
5. The composition of claim 1 , wherein the composition comprises an ester formed between a ketone body and HMB.
6. The composition of claim 1 , wherein the composition comprises a mixed anion salt comprising a multivalent cation, an exogenous ketone body anion, and an exogenous HMB anion.
7. The composition of claim 1 , wherein the composition comprises a mixed salt comprising a plurality of exogenous cations selected from the group consisting of lithium ions, sodium ions, potassium ions, magnesium ions, calcium ions, and amino acid cations, exogenous ketone body anions, and exogenous HMB anions.
8. The composition of claim 1 , wherein the composition is provided in solid or powder form.
9. The composition of claim 1 , wherein the composition is provided in liquid form.
10. The composition of claim 1 , wherein the composition is in a dosage form that provides from about 0.5 gram to about 50 grams, or about 1 gram to about 40 grams, or about 2 grams to about 30 grams, or about 3 grams to about 25 grams, or about 4 grams to about 20 grams, of the exogenous ketone body component.
11. The composition of claim 1 , wherein the composition is in a dosage form that provides about 0.25 gram to about 10 grams, or about 0.5 grams to about 5 grams, or about 1 gram to about 3 grams, of the exogenous HMB.
12. The composition of claim 1 , further comprising a pharmaceutically or dietetically acceptable carrier.
13. A mixed salt composition comprising:
a plurality of exogenous cations selected from alkali metal cations, alkaline earth metal cations, transition metal cations, and amino acid cations; and
a plurality of anions comprising exogenous ketone body anions and exogenous HMB anions,
wherein at least a portion of the mixed salt composition comprises a multivalent cation forming a salt with at least one exogenous ketone body anion and at least one exogenous HMB anion,
wherein the mixed salt composition includes a ratio of exogenous ketone body anions to exogenous HMB anions from about 4.5:1 to about 2.5:1 so as to be effective to increase lean mass to fat mass ratio in a mammal.
14. A method for administering exogenous ketone bodies and exogenous HMB to a mammal to increase lean mass to fat mass ratio in the mammal, comprising:
administering about 0.5 gram to about 50 grams of an exogenous ketone body component selected from beta-hydroxybutyrate (BHB) salts, BHB esters, beta-hydroxybutyric acid, and combinations thereof; and
administering about 0.25 gram to about 10 grams of exogenous HMB,
wherein a ratio of the exogenous ketone body component to the exogenous HMB is in a range of about 4.5:1 to about 2.5:1 so as to be effective to increase lean mass to fat mass ratio in the mammal.
15. The method of claim 14 , wherein administering comprises administering multiple doses per day.
16. The method of claim 14 , wherein the method is effective to provide one or more of homeostasis promotion, neuroprotection, memory enhancement, an anxiolytic effect, an anti-depressant effect, an anti-inflammatory effect, an analgesic effect, an antioxidant effect, blood pressure modulation, heart rate modulation, or a longevity promoting effect.
17. The method of claim 14 , wherein the ketone body component is effective to increase the pharmacokinetic utilization of the HMB relative to pharmacokinetic utilization of the HMB in the absence of the ketone body component.
18. The method of claim 14 , wherein the method is effective to accelerate the production of endogenous ketones in the mammal as a result of increased availability of ketone body precursors.
19. The method of claim 14 , wherein administering comprises one or more of ingestion, intragastric, injection, topical, inhalation, oral mucosal, rectal, vaginal, or parenteral.
20. A composition comprising:
an exogenous ketone body component selected from the group consisting of beta-hydroxybutyrate (BHB) salts, BHB esters, beta-hydroxybutyric acid, and combinations thereof; and
exogenous hydroxymethyl butyrate (HMB),
wherein the composition is in a dosage form that provides from about 0.5 gram to about 50 grams of the exogenous ketone body component and about 0.25 gram to about 10 grams of the exogenous HMB,
wherein a ratio of the exogenous ketone body component to the exogenous HMB is in a range of about 4.5:1 to about 2.5:1 so that the composition is effective to increase lean mass to fat mass ratio in a mammal.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 5, 2021
From: MILLET, GARY
To: AXCESS GLOBAL SCIENCES, LLC
Reel/Frame 057103/0137 →
Continuity (2)
Provisional Application
63070532
· Aug 26, 2020
References Cited (376)
US 2238149A
· Aeckerle
· 1941
[cited by applicant]
US 2976073A
· Russell et al.
· 1961
[cited by applicant]
US 4139761A
· Obrowski
· 1979
[cited by applicant]
US 4224503A
· Gijzel et al.
· 1980
[cited by applicant]
US 4292499A
· Kleinschmidt et al.
· 1981
[cited by applicant]
US 4627808A
· Hughes
· 1986
[cited by applicant]
US 4771074A
· Lammerant et al.
· 1988
[cited by applicant]
US 4969393A
· Mahlich et al.
· 1990
[cited by applicant]
US 4997976A
· Brunengraber et al.
· 1991
[cited by applicant]
US 5093044A
· Wretlind et al.
· 1992
[cited by applicant]
US 5100677A
· Veech
· 1992
[cited by applicant]
US 5116868A
· Chen et al.
· 1992
[cited by applicant]
US 5288512A
· Seiden
· 1994
[cited by applicant]
US 5292774A
· Hiraide et al.
· 1994
[cited by applicant]
US 5654266A
· Chen et al.
· 1997
[cited by applicant]
US 5700670A
· Yamagishi et al.
· 1997
[cited by applicant]
US 6207856B1
· Veech
· 2001
[cited by applicant]
US 6217915B1
· Luchansky et al.
· 2001
[cited by applicant]
US 6232345B1
· Hiraide et al.
· 2001
[cited by applicant]
US 6316038B1
· Veech
· 2001
[cited by applicant]
US 6323237B1
· Veech
· 2001
[cited by applicant]
US 6380244B2
· Martin et al.
· 2002
[cited by applicant]
US 6613356B1
· Vlahakos
· 2003
[cited by applicant]
US 6706756B1
· Fitzpatrick et al.
· 2004
[cited by applicant]
US 6835750B1
· Henderson
· 2004
[cited by applicant]
US 7351736B2
· Veech
· 2008
[cited by applicant]
US 7807718B2
· Hashim et al.
· 2010
[cited by applicant]
US 7891287B2
· Miller
· 2011
[cited by applicant]
US 8101653B2
· Veech
· 2012
[cited by applicant]
US 8124589B2
· Henderson
· 2012
[cited by applicant]
US 8344896B2
· Ozanne
· 2013
[cited by applicant]
US 8426468B2
· Henderson
· 2013
[cited by applicant]
US 8642654B2
· Clarke et al.
· 2014
[cited by applicant]
US 8748400B2
· Henderson
· 2014
[cited by applicant]
US 9138420B2
· D'Agostino et al.
· 2015
[cited by applicant]
US 9211275B2
· Clarke et al.
· 2015
[cited by applicant]
US 9435566B2
· Hill et al.
· 2016
[cited by applicant]
US 9675577B2
· D'Agostino et al.
· 2017
[cited by applicant]
US 9717767B2
· Carpenter et al.
· 2017
[cited by applicant]
US 9795580B2
· Weeber et al.
· 2017
[cited by applicant]
US 9808481B2
· Ritter et al.
· 2017
[cited by applicant]
US 9925164B1
· Hashim
· 2018
[cited by applicant]
US 9957246B2
· Stinchcomb et al.
· 2018
[cited by applicant]
US 20010014696A1
· Veech
· 2001
[cited by applicant]
US 20010018866A1
· Fischer
· 2001
[cited by applicant]
US 20010041736A1
· Veech
· 2001
[cited by applicant]
US 20020013339A1
· Martin et al.
· 2002
[cited by applicant]
US 20030022937A1
· Veech
· 2003
[cited by applicant]
US 20040138293A1
· Werner et al.
· 2004
[cited by applicant]
US 20050129783A1
· McCleary et al.
· 2005
[cited by applicant]
US 20060275253A1
· Ushida et al.
· 2006
[cited by applicant]
US 20070135376A1
· Henderson
· 2007
[cited by applicant]
US 20070179197A1
· Henderson
· 2007
[cited by applicant]
US 20080058416A1
· Greenwood et al.
· 2008
[cited by applicant]
US 20090253781A1
· Veech
· 2009
[cited by applicant]
US 20100041751A1
· Henderson
· 2010
[cited by applicant]
US 20100056631A1
· Hisamura et al.
· 2010
[cited by applicant]
US 20120053240A1
· Rathmacher et al.
· 2012
[cited by applicant]
US 20120071548A1
· Veech
· 2012
[cited by applicant]
US 20120202891A1
· Stinchcomb et al.
· 2012
[cited by applicant]
US 20130079406A1
· Veech
· 2013
[cited by applicant]
US 20130337116A1
· Petralia
· 2013
[cited by applicant]
US 20140256808A1
· Henderson
· 2014
[cited by applicant]
US 20140329893A1
· Veech
· 2014
[cited by applicant]
US 20140352728A1
· Svensson
· 2014
[cited by applicant]
US 20150065571A1
· Clarke et al.
· 2015
[cited by applicant]
US 20150363750A1
· Svensson et al.
· 2015
[cited by applicant]
US 20170298339A1
· Hanson et al.
· 2017
[cited by applicant]
US 20180021281A1
· Berger
· 2018
[cited by applicant]
US 20180055797A1
· Llosa et al.
· 2018
[cited by applicant]
US 20180057846A1
· Llosa et al.
· 2018
[cited by applicant]
US 20190099394A1
· Ari et al.
· 2019
[cited by applicant]
US 20190209501A1
· Tinsley et al.
· 2019
[cited by applicant]
US 20190313682A1
· Nagel
· 2019
[cited by applicant]
US 20200268701A1
· D'Agostino et al.
· 2020
[cited by applicant]
US 20210106168A1
· Cingolani et al.
· 2021
[cited by applicant]
CA 2990927A1
· 2018
[cited by applicant]
CN 86108978A
· 1987
[cited by applicant]
CN 1256629A
· 2000
[cited by applicant]
CN 1347319A
· 2002
[cited by applicant]
CN 1972698A
· 2007
[cited by applicant]
CN 101674730A
· 2010
[cited by applicant]
CN 101678043A
· 2010
[cited by applicant]
CN 101969769A
· 2011
[cited by applicant]
CN 102164884A
· 2011
[cited by applicant]
CN 104224823A
· 2014
[cited by applicant]
CN 105050594A
· 2015
[cited by applicant]
CN 106038532A
· 2016
[cited by applicant]
CN 106459646A
· 2017
[cited by applicant]
CN 106858066A
· 2017
[cited by applicant]
CN 108253621A
· 2018
[cited by applicant]
CN 109480284A
· 2019
[cited by applicant]
DE 102017210992A1
· 2019
[cited by applicant]
EP 0008700A1
· 1980
[cited by applicant]
EP 1112711A1
· 2001
[cited by applicant]
EP 1178748A1
· 2002
[cited by applicant]
EP 1827412A1
· 2007
[cited by applicant]
EP 1915144A2
· 2008
[cited by applicant]
EP 2283834A2
· 2011
[cited by applicant]
EP 2976073A1
· 2016
[cited by applicant]
EP 3094321A1
· 2016
[cited by applicant]
EP 3366173A2
· 2018
[cited by applicant]
EP 3446045A1
· 2019
[cited by applicant]
FR 2997302A1
· 2014
[cited by applicant]
GB 2391493A
· 2004
[cited by applicant]
ID 201701176
· 2017
[cited by applicant]
JP 11060434A
· 1999
[cited by applicant]
JP 2002521330A
· 2002
[cited by applicant]
JP 2004035417A
· 2004
[cited by applicant]
JP 2015042644A
· 2015
[cited by applicant]
JP 2015514104A
· 2015
[cited by applicant]
JP 2015102323A
· 2015
[cited by applicant]
JP 2016514725A
· 2016
[cited by applicant]
JP 2016121128A
· 2016
[cited by applicant]
JP 2017046688A
· 2017
[cited by applicant]
JP 2020502652A
· 2020
[cited by applicant]
JP 2020527583A
· 2020
[cited by applicant]
JP 2021504476A
· 2021
[cited by applicant]
JP 2021506294A
· 2021
[cited by applicant]
RU 2345546C2
· 2009
[cited by applicant]
WO 8703808A1
· 1987
[cited by applicant]
WO 9841200A1
· 1998
[cited by applicant]
WO 0069315A1
· 2000
[cited by applicant]
WO 0370823A2
· 2003
[cited by applicant]
WO 2005107724A1
· 2005
[cited by applicant]
WO 2006061624A1
· 2006
[cited by applicant]
WO 2007115282A2
· 2007
[cited by applicant]
WO 2008005818A1
· 2008
[cited by applicant]
WO 2008021394A2
· 2008
[cited by applicant]
WO 2008024408A2
· 2008
[cited by applicant]
WO 2009089144A1
· 2009
[cited by applicant]
WO 2010021766A1
· 2010
[cited by applicant]
WO 2011101171A1
· 2011
[cited by applicant]
WO 2012019295A1
· 2012
[cited by applicant]
WO 2013057506A1
· 2013
[cited by applicant]
WO 2013150153A1
· 2013
[cited by applicant]
WO 2014153416A1
· 2014
[cited by applicant]
WO 2015071811A1
· 2015
[cited by applicant]
WO 2015156865A1
· 2015
[cited by applicant]
WO 2016123229A1
· 2016
[cited by applicant]
WO 2016149687A1
· 2016
[cited by applicant]
WO 2017156446A1
· 2017
[cited by applicant]
WO 2017165443A1
· 2017
[cited by applicant]
WO 2017165445A1
· 2017
[cited by applicant]
WO 2017182664A1
· 2017
[cited by applicant]
WO 2017208217A2
· 2017
[cited by applicant]
WO 2018055388A1
· 2018
[cited by applicant]
WO 2018089863A1
· 2018
[cited by applicant]
WO 2018114309A1
· 2018
[cited by applicant]
WO 2018175879A1
· 2018
[cited by applicant]
WO 2018187324A1
· 2018
[cited by applicant]
WO 2018187852A1
· 2018
[cited by applicant]
WO 2019018683A1
· 2019
[cited by applicant]
WO 2019108683A1
· 2019
[cited by applicant]
WO 2019204148A1
· 2019
[cited by applicant]
WO 2019237152A1
· 2019
[cited by applicant]
WO 2020041871A1
· 2020
[cited by applicant]
Sorensen et al. (“Simultaneous determination of ≢-hydroxybutyrate and β-hydroxy-β-methylbutyrate in human whole blood using hydrophilic interaction liquid chromatography electrospray tandem mass spectrometry”, Clinical …
[cited by examiner]
A New Toy Measuring Blood Ketones. Diet Doctor, Aug. 21, 2012. Downloaded Apr. 1, 2015. http://www.dietdoctor.com/a-new-toy-measuring-blood-ketoones.
[cited by applicant]
Acetoacetate, Acetone, and Dibenzylamine (A Contaminant in L-(+)-Beta-Hydroxybutyrate) Exhibit Direct Anticonvulsant Actions in Vivo, Epilepsia, Raven Press Ltd, New York, US, vol. 43, No. 4, Apr. 1, 2002 (Apr. 1, 2002)…
[cited by applicant]
Amazon, “Perfect Keto Perform Pre Workout Powder—Burn Fat for Fuel Energy Supplement Drink Mix for Men and Women—Keto Friendly with Ketone Salts, BCAA, Nitric Oxide & MCT”, Sep. 25, 2017 entire document especially p. 1 …
[cited by applicant]
Arendash et al. “Caffeine and Coffee as Therapeutics Against Alzheimer's Disease”, Journal of Alzheimer's Disease 20, 2010, S117-S126.
[cited by applicant]
Bastin et al., “Salt Slection and Optimisation Procedures for Pharmaceutical New Chemical Entities”, American Chemical Society and The Royal Society of Chemistry, vol. 4, No. 5, 2000, pp. 427-435.
[cited by applicant]
Blazquez et al. Journal of Neurochemistry, 1999, vol. 72 No. 4, pp. 1759-1768. (Year: 1999).
[cited by applicant]
Clarke, et al., Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. Regul Toxicol Pharmacol. Aug. 2012; 63(3):401-8.
[cited by applicant]
Craciun, S. et al. Microbial conversion of choline to trimethylamine requires a glycyl radical enzyme, 2012, PNAS, 109(52): 21307-21312 (Year: 2012).
[cited by applicant]
Cresci, G. et al., Lactobacillus GG and Tributyrin Supplementation Reduce Antibiotic-Induced Intestinal Injury, 2013, Journal of Parenteral and Enteral Nutrition, 37(6), 1-20 (Year: 2013).
[cited by applicant]
Dietary Guidelines Recommendations at https://health.gov/our-work/food-nutrition/2015-2020-dietary-guidelines/guidelines/ appendix-7/ (2010) (retrieved from the internet Oct. 20, 2020) (Year: 2010).
[cited by applicant]
Dolson, Laura. How to Test Your Blood for Ketones. Downloaded Apr. 1, 2015. http://lowcarbdiets.about.eom/od/KetogenicDiets/a/How-to-Test-Blood-For-Ketones.htm.
[cited by applicant]
Extended European Search Report issued in PCT/US2017021886 dated Oct. 17, 2019.
[cited by applicant]
First Examination Report for New Zealand Patent Application No. 711433 issued by the New Zealand Intellectual Property Office dated Mar. 10, 2016.
[cited by applicant]
First Office Action issued by the Chinese State Intellectual Property Office on Nov. 4, 2016 for corresponding Chinese Patent Application No. 201480016818.0.
[cited by applicant]
Haces M L et al: “Antioxidant capacity contributes to protection of ketone bodies against oxidative damage induced during hypoglycemic conditions”, Experimental Neurology, Elsevier, Amsterdam, NL, vol. 211, No. 1, May 1…
[cited by applicant]
Hashim, Sami A., et al., “Ketone body therapy: from the ketogenic diet to the oral administration of ketone ester”, Journal of Lipid Research, vol. 55, 2014.
[cited by applicant]
Haywood A, Glass BD. Pharmaceutical excipients—where do we begin? Australian Prescriber. 2011; 34: 112-114.
[cited by applicant]
Henderson, Samuel T. “Ketone Bodies as a Therapeutic for Alzheimer's Disease.” Neurotherapeutics. Jul. 2008; 5(3):470-80.
[cited by applicant]
Holtzman et al., “Role of adenosine receptors in caffeine tolerance”, J. Pharmacol. Exp. Ther., 1991 ; 256(1 ):62-68.
[cited by applicant]
Ichim, T. et al., Experimental support for the effects of a probiotic/digestive enzyme supplement on serum cholesterol concentrations and the intestinal microbiome, 2016, Journal of Translational Medicine, 14(184), 1-9 …
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2020/016952, mailed on Aug. 26, 2021, 7 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/048364, mailed on Mar. 11, 2021, 7 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2020/017552, mailed on Aug. 26, 2021, 7 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2020/017555, mailed on Aug. 26, 2021, 7 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2020/017556, mailed on Aug. 26, 2021, 7 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2020/033159, mailed on Nov. 25, 2021, 6 pages.
[cited by applicant]
International Search Report and Written Opinion issued in PCT/US19/48357 dated Nov. 18, 2019.
[cited by applicant]
International Search Report and Written Opinion issued in PCT/US19/48364 dated Nov. 15, 2019.
[cited by applicant]
International Search Report and Written Opinion issued in PCT/US20/16952 dated Apr. 22, 2020.
[cited by applicant]
International Search Report and Written Opinion issued in PCT/US20/17552 dated May 4, 2020.
[cited by applicant]
International Search Report and Written Opinion issued in PCT/US20/17555 dated May 4, 2020.
[cited by applicant]
International Search Report and Written Opinion issued in PCT/US20/17556 dated May 4, 2020.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US20/017555, mailed on May 4, 2020, 8 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US20/37289, mailed or Sep. 30, 2020, 8 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2020/033159, mailed on Aug. 12, 2020, 9 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US21/17078, mailed on Apr. 23, 2021, 9 pages.
[cited by applicant]
International Search Report cited in PCT/US18/62093 dated Feb. 1, 2019.
[cited by applicant]
International Search Report cited in PCT/US19/27214 dated Jun. 25, 2019.
[cited by applicant]
It Really is in Your Blood: Glucose to Ketone Ratios. Greymadder, Sep. 15, 2014. Downloaded Apr. 1, 2015. http://greymadder.net/2014/09/15/it-really-is-in-your-blood-glucose-to-ketone-ratios/.
[cited by applicant]
James, “Optical Purity and Enantiomeric Excess” at https://www.masterorganicchemistry.com/2017/02/24/optical-purity-and-enantiomeric-excess/. (Retrieved from the internet Nov. 6, 2018) (Year. 2018).
[cited by applicant]
Karppanen et al, J. Human Hypertension (2005), vol. 19, pp. S10-S19. (Year: 2005).
[cited by applicant]
Kesl, et al., “Effects of exogenous ketone supplementation on blood ketone, glucose, triglyceride, and lipoprotein levels in Spraque-Dawley rats”, Nutrition & Metabolism (2016).
[cited by applicant]
Kirsch, JR et al. “Butanediol Induced Ketosis Increases Tolerance to Hypoxia in the Mouse.” Stroke. 1980. vol. 11, No. 5, pp. 506-513.
[cited by applicant]
Kossoff, Eric H. et al. “Optimal Clinical Management of Children Receiving the Ketogenic Diet: Recommendations of the International Ketogenic Diet Study Group.” Epilepsia, Feb. 2009; 50(2):304-17. Epub Sep. 23, 2008.
[cited by applicant]
European Search Report received for EP Patent Application No. 20805593.9, mailed on Dec. 16, 2022, 9 pages.
[cited by applicant]
Maguire et al., “Gut dysbiosis, leaky gut, and intestinal epithelial proliferation in neurological disorders: towards the development of a new therapeutic using amino acids, prebiotics, probiotics, and postbiotics”, Rev…
[cited by applicant]
Rich A.J., “Ketone Bodies as Substrates,” Proceedings of the Nutrition Society (1990), vol. 49, 361-373.
[cited by applicant]
Wu et al., “Medium-Chain Triglycerides in Infant Formulas and Their Relation to Plasma Ketone Body Concentrations,” Pediatric Research, vol. 20, No. 4, (1986), pp. 338-341.
[cited by applicant]
Yang Y. et al., Role of Adherent-Invasive
[cited by applicant]
European Search Report received for EP Patent Application No. 20755289.4, mailed on Oct. 11, 2022, 7 pages.
[cited by applicant]
European Search Report received for EP Patent Application No. 20755994.9, mailed on Sep. 21, 2022, 6 pages.
[cited by applicant]
Extended European Search Report received for EP Patent Application No. 20755770.3, mailed on Sep. 1, 2022, 7 pages.
[cited by applicant]
Grootaert, C. Comparison of prebiotic effects of arabinoxylan oligosaccharides and inulin in a simulator of the human intestinal microbial ecosystem, 2009, FEMS Microbiology Ecology, 69: 231-242 (Year: 2009).
[cited by applicant]
Holscher, H. Dietary fiber and prebiotics and the gastrointestinal microbiota, 2017, Gut Microbes, 8(2): 172-184 (Year: 2017).
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2021/017078, mailed on Aug. 18, 2022, 7 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2021/063559, mailed on Mar. 18, 2022, 9 pages.
[cited by applicant]
John C Newman et al: “beta-Hydroxybutyrate: A Signaling Metabolite”, Annual Review of Nutrition, vol. 37, Aug. 21, 2017 (Aug. 21, 2017), pp. 51-76, XP055771586.
[cited by applicant]
Lile et al. Drug Alcohol Depend. 2012, 122 (1-2), 61-69.
[cited by applicant]
National Center for Biotechnology Information. PubChem Compound Summary for CID 441, 3-Hydroxybutyric acid, https://pubchem.ncbi.nlm.nih.gov/compound/3-Hydroxybutyric-acid. (Year: 2005).
[cited by applicant]
Parker, Steve, “Ketogenic Mediterraanean Diet: Version 2.3,” Nov. 23, 2010, pp. 1-3. (Year: 2010).
[cited by applicant]
Sanchez, J. I. et al. Arabinoxylan-oligosaccharides (AXOS) affect the protein/carbohydrate fermentation balance and microbial population dynamics of the Simulator of Human Intestinal Microbial Ecosystem, 2009, Microbial…
[cited by applicant]
Slavin, J. Fiber and Prebiotics: Mechanisms and Health Benefits, 2013, Nutrients, 5: 1417-1425 (Year: 2013).
[cited by applicant]
The Medical Republic, 2018, Sustained Release Sodium Butyrate Supplement Now Available to Support Management of GI Disorders, https://medicalrepublic.com.au/sustained-release-sodium-butyrate-supplement-now-available-sup…
[cited by applicant]
Walton, G. et al. A randomised, double-blind, placebo controlled cross-over study to determine the gastrointestinal effects of consumption of arabinoxylan-oligosaccharides enriched bread in healthy volunteers, 2012, Nut…
[cited by applicant]
Zaleski, A. et al., Butyric acid in irritable bowel syndrome, 2013, Prz Gastroenterol, 8(6), 350-353 (Year: 2013).
[cited by applicant]
Extended European Search Report received for EP Patent Application No. 19788264.0, mailed on Dec. 20, 2021, 11 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US20/37289, mailed on Dec. 30, 2021, 6 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US21/045186, mailed on Nov. 22, 2021, 10 pages.
[cited by applicant]
Kim Do Young et al., “Ketone bodies are protective against oxidative stress in neocortical neurons,” Journal of Neurochemistry, vol. 101, Issue 5, Jun. 1, 2007, pp. 1316-1326.
[cited by applicant]
Maalouf Met al., “Ketones inhibit mitochondrial production of reactive oxygen species production following glutamate excitotoxicity by increasing NADH oxidation,” Neuroscience, New York, NY, US, vol. 145, Issue 1, Mar. …
[cited by applicant]
Maalouf Met al., “The neuroprotective properties of calorie restriction, the ketogenic diet, and ketone bodies,” Brain Research Reviews, Elsevier, NL, vol. 59, No. 2, Mar. 1, 2009, pp. 293-315.
[cited by applicant]
Pete J Cox et al., “Acute nutritional ketosis: implications for exercise performance and metabolism,” Extreme Physiology & Medicine, vol. 3, Issue 1, Dec. 1, 2014, pp. 1-9.
[cited by applicant]
Krotkiewski, “Value of VLCD Supplementation with Medium Chain Triglycerides”, Int J Obes Relat Metab Disord, Sep. 2001, 25(9), pp. 1393-1400.
[cited by applicant]
Malo, M. S. et. al., Intestinal alkaline phosphatase preserves the normal homeostasis of gut microbiota, 2010, Gut, 59, 1476-1484 (Year: 2010).
[cited by applicant]
Murray, Andrew J., et al. “Novel ketone diet enhances physical and cognitive performance”, The FASEB Journal, No. Dec. 30, 2016.
[cited by applicant]
Nova Max Plus Glucose and Ketone Testing with One Monitor. Downloaded Apr. 1, 2015. http://www.novacares.com/nova-max-plus/.
[cited by applicant]
Optical Purity and Enantiomeric Excess at https://www.masterorganicchemistry.com/2017/02/24/optical-purity-and-enantiomeric-excess/. (Retrieved from the internet Nov. 6, 2018) (Year: 2018).
[cited by applicant]
Parker, Steve, “Ketogenic Mediterranean Diet: Version 2.3,” Nov. 23, 2010, pp. 1-3. (Year: 2010).
[cited by applicant]
PCT International Search Report and Written Opinion issued by the International Searching Authority on Jul. 15, 2014 or International Patent Application No. PCT/US2014/031237.
[cited by applicant]
Precision Xtra vs. NovaMax Plus: Ketone Meter Evaluation. Jimmy Moore's Livin' La Vida Low Garb Blog. Downloaded Apr. 1, 2015. http://livinlavidalowcarb.com/blog/precision-xtra-vs-novamax-plus-ketone-meter-evaluation/15…
[cited by applicant]
Pubchem, “Acetoacetic acid” Electronic Resource: https://pubchem.ncbi.nim.nih.gov/compound/Acetoacetic-acid, Retrieved on Sep. 3, 2019.
[cited by applicant]
Robson et al. Expert Opin. Drug Saf. (2011), vol. 10, pp. 675-685 (Year: 2011).
[cited by applicant]
Roeder, Lois M., et al. The Effects of Ketone Bodies, Bicarbonate, and Calcium on Hepatic Mitochondrial Ketogenesis. Archives of Biochemistry and Biophysics, vol. 217, No. 2, Sep. pp. 460-467, 1982.
[cited by applicant]
Sajewicz et al. In Journal of Liquid Chromatography & Related Technologies, 33:1047-1057 (2010) (Year: 2010).
[cited by applicant]
Serum Ketones Test. MedlinePlus Medical Encyclopedia. Downloaded Apr. 1, 2015. http://www.nlm.nih.gov/medlineplus/ency/article/003498.htm.
[cited by applicant]
Shigeno et al. In Biosci. Biotech. Biochem., 56(2), 320-323 (1992) (Year: 1992).
[cited by applicant]
Stubbs et al., “On the Metabolism of Exogenous Ketones in Humans”, frontiers in Physiology, vol. 8, 2017, 13 pages.
[cited by applicant]
Tanaka, J., et al., “Significance of Blood Ketone Body Ration as an indicator of Hepatic Cellular Energy Status in Jaundiced Rabbits”, Gastroenterology, 1979, vol. 76, No. 4, pp. 691-696.
[cited by applicant]
Tisdale, “Reduction of weight loss and tumour size in a cachexia model by a high fat diet”, British Journal of Cancer, Jul. 1987, vol. 56, p. 39-43.
[cited by applicant]
Tsai et al., “Stereoselective effects of 3-hydroxybutyrate on glucose utilization of rat cardiomyocytes” life Sciences 78(2006) pp. 1385-1391.
[cited by applicant]
Vandenberghe et al. In Can. J. Physiol. Pharmacol. 95: 455-458 (2017) (Published at www.nrcresearchpress.com/cjpp on Nov. 25, 2016). (Year: 2016).
[cited by applicant]
Veech, et al., “Ketone Bodies Mimic the Life Span Extending Properties of Caloric Restriction”, IUBMB Life Feb. 8, 2017.
[cited by applicant]
Veech, Richard L. “The Therapeutic Implications of Ketone Bodies: The Effects of Ketone Bodies in Pathological Conditions: Ketosis, Ketogenic Diet, Redox States, Insulin Resistance, and Mitochondrial Metabolism.” Prosta…
[cited by applicant]
Vorgerd, M. And J. Zange. Treatment of glycogenosys type V (McArdle disease) with creatine and ketogenic diet with clinical scores and with 31P-MRS on working leg muscle. Acta Myologica, 2007; XXVI; pp. 61-63.
[cited by applicant]
Anonymous: “Blue Lemon Ice Advanced Formula”, MINTEL, Database accession No. 4315637, 2016, pp. 3.
[cited by applicant]
Anonymous: “Strawberry Pineapple Flavour Pre-Exertion Performance Optimizer”, MINTEL, Database accession No. 5661617, 2018, pp. 4.
[cited by applicant]
Budin. N. et al., “Efficient synthesis of the ketone body ester (R)-3-hydroxybutyryl-(R)-3-hydroxybutyrate and its (S, S) enantiomer,” Bioorganic Chemistry, vol. 80, Oct. 2018, pp. 560-564.
[cited by applicant]
Huang Dexiang, “Clinical Parenteral nutrition”, Jan. 31, 1994, pp. 1-20.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2018/062093, mailed on Jun. 4, 2020, 6 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2021/045186, mailed on Mar. 9, 2023, 7 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2021/050302, mailed on Mar. 2, 2023, 8 pages.
[cited by applicant]
Kaster M.P. et al, “Caffeine acts through neuronal adenosine A2A receptors to prevent mood and memory dysfunction triggered by chronic stress”, Proceedings of the National Academy of Sciences, vol. 112, No. 25, Jun. 8, …
[cited by applicant]
Lonza, Duocap Capsules, Feb. 16, 2018, https ://web .archive.org/web/20180216001656/https://www.capsugel.com/consumer-health-nutrition-products/duocap-capsules (Year: 2018).
[cited by applicant]
Luis Villasenor, “Supplements and Ketogenic Diets—Facts and Myths”, Retrieved from https://www.ketogains.com/2015/09/supplements-and-ketogenic-diets-facts-and-myths/, Sep. 18, 2015, pp. 15.
[cited by applicant]
Lytra. G. et al., “Distribution and Organoleptic Impact of Ethyl 3-Hydroxybutanoate Enantiomers in Wine,” J. Agric. Food Chem, vol. 63, Issue 48, 2015, pp. 10484-10491.
[cited by applicant]
Mangels D.R. et al, “Catechins as Potential Mediators of Cardiovascular Health”, Translational Sciences, vol. 37, No. 5, May 1, 2017, pp. 757-763.
[cited by applicant]
Arnold, Instant Ketosis?, (2013), Aug. 4, 2013 (retrieved on Apr. 21, 2017), p. 1-3. Retrieved from the internet; URL: < http:// patrickarnoldblog.com/instant-ketosis/. (Year: 2013).
[cited by applicant]
Bala et al. Drug Invention Today. Jun. 1, 2018;10(6), 929-931.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2014/031237, mailed on Oct. 1, 2015, 8 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2017/021886, mailed on Sep. 20, 2018, 9 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2018/062096, mailed on Jul. 2, 2020, 8 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/027214, mailed on Oct. 29, 2020, 09 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/048357, mailed on Mar. 11, 2021, 08 pages.
[cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2021/063559, mailed on Jul. 6, 2023, 6 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2014/031237, mailed on Jul. 15, 2014, 11 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2017/021886, mailed on Jun. 1, 2017, 15 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2018/062096, mailed on Feb. 11, 2019, 13 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/027214, mailed on Jun. 25, 2019, 14 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/048357, mailed on Nov. 18, 2019, 13 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2020/016952, mailed on Apr. 22, 2020, 9 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2020/017552, mailed on May 4, 2020, 9 pages.
[cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2020/017556, mailed on May 4, 2020, 12 pages.
[cited by applicant]
Lang Chaochun, “Healthy fitness and exercise prescription”, Nov. 30, 2013, p. 201.
[cited by applicant]
O'Meara, Cyndi, Changing Habits, Ketosis—Can we achieve it in a pill?, https://changinghabits.com.au/ketosis-can-we-achieve-it-in-a-pill/, 12 pages, (Jan. 13, 2017).
[cited by applicant]
Sara, How do you know which product is right for you? How to choose exogenous ketones, https://ketosupplements.co.uk/how-to-choose-exogenous-ketones/, 10 pages, (Sep. 25, 2017).
[cited by applicant]
Short, Jay, Effects of A Ketone/Caffeine Supplement On Cycling and Cognitive Performance, Master's thesis, Ohio State University, 61 pages, (Jan. 1, 2017).
[cited by applicant]
Yang Yue et al., “Research on sarcopenic obesity”, Chinese Journal of Modern Medicine, vol. 20, No. 3, Mar. 25, 2018, pp. 98-101.
[cited by applicant]
Yang Zeyi, “Biochemistry of sports nutrition scientific research progress”, Mar. 31, 2004, vol. 23, No. 2, pp. 158-165.
[cited by applicant]
Zeng Jing et al., “B-hydroxy-3-methyl—The clinical effects and mechanism”, vol. 2, No. 2, Jun. 9, 2015, pp. 57-62.
[cited by applicant]
European Search Report received for EP Patent Application No. 21750261.6, mailed on Feb. 2, 2024, 10 pages.
[cited by applicant]
O'Mailey et al, Appl. Physiol. Nutr. Metab. 42: 1031-1035 (2017) Published at www.NRCRESEARCHPRESS.com/APNM on Jul. 27, 2017.
[cited by applicant]
Office Action received for European Patent Application No. 19788264.0, mailed on Mar. 13, 2024, 5 pages.
[cited by applicant]
Office Action received for European Patent Application No. 20805593.9, mailed on Dec. 22, 2023, 7 pages.
[cited by applicant]
WO2009045481, Pan et al. Published Apr. 9, 2009 Listed in this section as citation type “foreign” does not allow for any appropriate country code for “WO” documents.
[cited by applicant]
European Search Report received for EP Patent Application No. 21862356.9, mailed on Jul. 1, 2024, 10 pages.
[cited by applicant]