WO2021240461A1 - Compléments alimentaires - Google Patents

Compléments alimentaires Download PDF

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Publication number
WO2021240461A1
WO2021240461A1 PCT/IB2021/054699 IB2021054699W WO2021240461A1 WO 2021240461 A1 WO2021240461 A1 WO 2021240461A1 IB 2021054699 W IB2021054699 W IB 2021054699W WO 2021240461 A1 WO2021240461 A1 WO 2021240461A1
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Prior art keywords
component
composition
turmeric
cinnamon
curcumin
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PCT/IB2021/054699
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English (en)
Inventor
Diane Clayton
Mark James LOWMAN
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Neolife International LLC
Hgf Limited
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Publication of WO2021240461A1 publication Critical patent/WO2021240461A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/121—Ketones acyclic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/062—Ascomycota
    • A61K36/064—Saccharomycetales, e.g. baker's yeast
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
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    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis

Definitions

  • This invention relates to a composition
  • a composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; for use in the treatment, progression or prevention of (i) a disease or condition related to poor blood glucose control; (ii) a disease or condition related to a state of progressive low level chronic inflammation; and/or (iii) a disease or condition treatable by reducing triglyceride levels.
  • this invention relates to a composition
  • a composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; for use in the treatment, progression or prevention of (i) a disease or condition selected from the group consisting of obesity, pre-diabetes, metabolic syndrome, type II diabetes, atherosclerosis, chronic kidney disease, Alzheimer's type and related dementias (Alzheimer's disease, vascular dementia, Lewy body disease, frontotemporal dementia, mixed dementia), cardiovascular disease and arthritis.
  • a disease or condition selected from the group consisting of obesity, pre-diabetes, metabolic syndrome, type II diabetes, atherosclerosis, chronic kidney disease, Alzheimer's type and related dementias (Alzheimer's disease, vascular dementia, Lewy body disease, frontotemporal dementia, mixed dementia), cardiovascular disease and arthritis.
  • Dyslipidaemia is described as abnormal levels of circulating lipids, presenting a high risk for CVD development. Its etiology can be primary (genetic) or secondary (diet, drugs, chronic diseases and metabolic disorders, including obesity, metabolic syndrome (MetS) and type 2 diabetes (T2D).
  • DLP triglycerides
  • TC total cholesterol
  • HDL-C high-density lipoprotein-cholesterol
  • LDL-C low-density lipoprotein-cholesterol
  • non-HDL- C non-HDL- C.
  • Glycative stress caused by the accumulation of cytotoxic and irreversibly-formed sugar-derived advanced glycation end-products (AGEs), has been reported to contribute to morbidity associated with aging, age related diseases, and metabolic diseases (Rowan et al, Biochim Biophys Acta Mol Basis Dis. 2018 December; 1864(12): 3631-3643).
  • the authors report that glycotoxins (/.e. glycation products) have been shown to accumulate in aging diseases like Alzheimer’s disease, renal failure, and cardiac disease. Accumulation of AGEs is regarded as a ‘hallmark’ of many of the chronic diseases associated with high morbidity and mortality and remains a viable target for intervention.
  • Cinnamon can increase insulin sensitivity, decrease adipogenesis and lipogenesis, decrease glycogenolysis and intestinal glucose absorption, and enhance insulin secretion, thus increasing glucose uptake and glycogen synthesis (Anderson et al., 2016 J Tradit Complement Med, 6, 332-336; Hlebowicz et al., 2009 Am J Clin Nutr, 89, 815-21.; Kang et al., 2019. Nutrients, 11, 577; Ranasignhe et al., 2012 Diabetic Medicine, 29, 1480-1492).
  • Turmeric and curcumin can increase insulin secretion and glucose uptake, whilst decreasing glycogenolysis, inflammation, gluconeogenesis, and insulin resistance. Additional benefits to cognition and mood have been found with curcumin supplementation.
  • Proanthocyanidins found in components such as cinnamon have been found to aid in the reduction of the formation of advanced glycation end products, which are formed as oxidant end products in individuals with diabetes (Fujiwara et al., 2008 Diabetes Clin Practi 80, 185- 191 ; Jang et al., 2008 Metabolism 57, 1576-1583; Kang et al., 2013, Eur Rev Med Pharmacol Sci, 17, 2578-2586; Wickenberg et al. 2010. Nutrition Journal, 9, 43.; Qin et al. 2017, Nutrition Journal, 16:68.; Cox et al. 2014. J Psychopharmacol. 29, 642-651.).
  • Alpha-lipoic acid (1, 2-dithiolane-3-pentanoic acid; ALA) or thioctic acid is a natural short-chain fatty acid recognized for its antioxidant and anti-inflammatory properties and potential positive influence on lipid metabolism (Fogacci et al. 2020. Safety Evaluation of a- Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies Antioxidants (Basel). 2020;9(1G):1G11. Mousavi et al. 2019. Effect of alpha-lipoic acid supplementation on lipid profile: A systematic review and meta-analysis of controlled clinical trials. Nutrition. 2019 Mar; 59:121-130.).
  • Chromium is a trace element, which as trivative chromium (Cr3+) may play a role in normal insulin function.
  • Cr3+ trivative chromium
  • chromium supplementation improved some measure of glucose utilization and/or had beneficial effects on blood lipid profiles.
  • substantial proof of efficacy from human clinical trials remains elusive (Hua et al. 2012. Molecular mechanisms of chromium in alleviating insulin resistance. J Nutr Biochem. 2012;23(4):313-319. doi:10.1016/j.jnutbio.2011.11.001).
  • composition comprising (a) a cinnamon component; (b) a turmeric and/or curcumin component; and (c) a chromium component and/or alpha-lipoic acid; for use in the treatment, progression or prevention of a disease or condition related to poor blood glucose control; a disease or condition related to a state of progressive low level chronic inflammation; and/or a disease or condition treatable by reducing triglyceride levels.
  • composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component, wherein the ratio of cinnamon component : turmeric/curcumin component ranges from 10 : 1 to 1 : 10 w/w, for use in the treatment, progression or prevention of a disease or condition related to poor blood glucose control; a disease or condition related to a state of progressive low level chronic inflammation; and/or a disease or condition treatable by reducing triglyceride levels.
  • composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; for use in the treatment, progression or prevention of a disease or condition related to poor blood glucose control; and/or (ii) a disease or condition related to a state of progressive low level chronic inflammation.
  • a pharmaceutical or nutraceutical composition comprising the composition of the first or second aspects and a pharmaceutically acceptable excipient or an excipient that is allowed for use in a nutraceutical composition for use in the treatment, progression or prevention of a disease or condition related to poor blood glucose control; a disease or condition related to a state of progressive low level chronic inflammation; and/or a disease or condition treatable by reducing triglyceride levels.
  • a pharmaceutical or nutraceutical composition comprising the composition of the first aspect and a pharmaceutically acceptable excipient or an excipient that is allowed for use in a nutraceutical composition for use in the treatment, progression or prevention of a disease or condition related to poor blood glucose control; and/or (ii) a disease or condition related to a state of progressive low level chronic inflammation.
  • Figure 3 demonstrates that levels of triglycerides (mg/dl +/- SE) fell when taking the supplement: baseline to month 2 (p ⁇ 0.002) and month 3 (p ⁇ 0.015). With the placebo there was a significant increase at month 3 (p ⁇ 0.041). The subjects were those with poor glucose tolerance.
  • Figure 4 relates to fasting C-Reactive Protein (CRP), a serum marker of inflammation.
  • CRP C-Reactive Protein
  • Figure 6 relates to glucose profiles from the OGTT after two months visit.
  • the condition (A / P) X Visit (1 ,2,3) X Time quadratic interactions is currently p 0.3.
  • Figure 8 Effect of the cinnamon/turmeric/curcumin spice powder blend (SPB) on THP-1 cell viability by MTT test. Different concentrations of SPB (from 1.25 to 20 pg/ml) were added to the culture medium for 24 h and then cell viability was assessed by the MTT test. Results are expressed as percentages of the values detected in untreated cultures (CTRL). Data are means ⁇ SEM of three independent experiments performed in eight replicates.
  • SPB cinnamon/turmeric/curcumin spice powder blend
  • an individual described as having “poor blood glucose control” includes individuals having a baseline HbA1c value above 5.9%.
  • the composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; is for use in the treatment, progression or prevention of a condition treatable by reducing triglyceride levels.
  • a condition treatable by reducing triglyceride levels is reduced upon administration of the composition of the invention.
  • the composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; is for use in the treatment, progression or prevention of dyslipidemia (a profile of low HDL, high LDL and high triglycerides).
  • the composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; is for use in the treatment, progression or prevention of hypertriglyceridemia.
  • the composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; is for use in the treatment, progression or prevention of a disease or condition treatable by normalising blood lipid levels.
  • the composition comprising (a) a cinnamon component; and (b) a turmeric and/or curcumin component; is for use in the treatment, progression or prevention of (i) a disease or condition selected from the group consisting of obesity, pre-diabetes, metabolic syndrome, type II diabetes, atherosclerosis, chronic kidney disease, Alzheimer's type and related dementias (Alzheimer's disease, vascular dementia, Lewy body disease, frontotemporal dementia, mixed dementia), cardiovascular disease and arthritis.
  • a disease or condition selected from the group consisting of obesity, pre-diabetes, metabolic syndrome, type II diabetes, atherosclerosis, chronic kidney disease, Alzheimer's type and related dementias (Alzheimer's disease, vascular dementia, Lewy body disease, frontotemporal dementia, mixed dementia), cardiovascular disease and arthritis.
  • the composition of the present invention is administered at least once daily for a minimum period of two months. In a preferred embodiment, the composition of the present invention is administered twice daily. In a more preferred embodiment, the composition of the present invention is administered twice daily each dose being taken before eating (e.g. 30 minutes before eating).
  • the daily dosage of cinnamon component is from 100 mg to 5 g. In an embodiment, the daily dosage of cinnamon component is from 250 mg to 3 g. In an embodiment, the daily dosage of cinnamon component is from 500 mg to 1.5 g. Preferably, the daily dosage of cinnamon component is 1 g.
  • the daily dosage of turmeric component is from 20 mg to 3 g. In an embodiment, the daily dosage of turmeric component is from 50 mg to 1 g. In an embodiment, the daily dosage of turmeric component is from 50 mg to 600 mg. In an embodiment, the daily dosage of turmeric component is from 100 mg to 300mg. Preferably, the daily dosage of turmeric component is 200 mg.
  • the daily dosage of curcumin component is from 20 mg to 3 g. In an embodiment, the daily dosage of curcumin component is from 50 mg to 1 g. In an embodiment, the daily dosage of curcumin component is from 50 mg to 600 mg. In an embodiment, the daily dosage of curcumin component is from 100 mg to 300mg. Preferably, the daily dosage of curcumin component is 200 mg.
  • the composition comprises a cinnamon component and a turmeric component.
  • the composition comprises a cinnamon component and a curcumin component.
  • the composition comprises a cinnamon component, a turmeric component and a curcumin component.
  • the ratio of cinnamon component : turmeric/curcumin component ranges from 150 : 1 to 1 : 150 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 100 : 1 to 1 : 100 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 50 : 1 to 1 : 50 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 40 : 1 to 1 : 40 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 30 : 1 to 1 : 30 w/w.
  • the ratio of cinnamon component : turmeric/curcumin component ranges from 20 : 1 to 1 : 20 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 10 : 1 to 1 : 10 w/w.
  • the ratio of cinnamon component : turmeric/curcumin component ranges from 10 : 1 to 1 : 5 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 10 : 1 to 1 : 2 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 10 : 1 to 1 : 1 w/w.
  • the ratio of cinnamon component : turmeric/curcumin component ranges from 5 : 1 to 1 : 5 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 5 : 1 to 1 : 2 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 5 : 1 to 1 : 1 w/w.
  • the ratio of cinnamon component : turmeric/curcumin component ranges from 5 : 1 to 1 : 5 w/w. In an embodiment, the ratio of cinnamon component : turmeric/curcumin component ranges from 5 : 2 to 1 : 2 w/w.
  • the ratio of cinnamon component : turmeric component : curcumin component ranges from 300 : 1 : 1 to 1 : 75 : 75 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 200 : 1 : 1 to 1 : 50 : 50 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 100 : 1 : 1 to 1 : 25 : 25 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 80 : 1 : 1 to 1 : 20 : 20 w/w.
  • the ratio of cinnamon component : turmeric component : curcumin component ranges from 60 : 1 : 1 to 1 : 15 : 15 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 40 : 1 : 1 to 1 : 10 : 10 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 20 : 1 : 1 to 1 : 5 : 5 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 10 : 1 : 1 to 1 : 2.5 : 2.5 w/w.
  • the ratio of cinnamon component : turmeric component : curcumin component ranges from 20 : 1 : 1 to 1 : 2.5 : 2.5 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 20 : 1 : 1 to 1 : 1 : 1 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 20 : 1 : 1 to 1 : 0.5 : 0.5 w/w.
  • the ratio of cinnamon component : turmeric component : curcumin component ranges from 10 : 1 : 1 to 1 : 2.5 : 2.5 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 10 : 1 : 1 to 1 : 1 : 1 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 10 : 1 : 1 to 1 : 0.5 : 0.5 w/w.
  • the ratio of cinnamon component : turmeric component : curcumin component ranges from 10 : 1 : 1 to 1 : 2.5 : 2.5 w/w. In an embodiment, the ratio of cinnamon component : turmeric component : curcumin component ranges from 5 : 1 : 1 to 1 : 1 : 1 w/w.
  • the composition further comprises a chromium component, e.g. a trivalent chromium (Cr(lll)) component.
  • the composition comprises a cinnamon component, a turmeric component, a curcumin component and a trivalent chromium (Cr(lll)) component.
  • the chromium component is selected from chromium yeast, chromium chloride, chromium citrate, chromium nicotinate, chromium picolinate and chromium histidinate.
  • the chromium component is a chromium yeast.
  • the composition further comprises alpha-lipoic acid (DL-thioctic acid).
  • the composition comprises a cinnamon component, a turmeric component, a curcumin component and alpha-lipoic acid.
  • the composition comprises a cinnamon component, a turmeric component, a curcumin component, a chromium component and alpha-lipoic acid.
  • the turmeric component is selected from turmeric extract and turmeric powder. In an embodiment, the turmeric component is turmeric powder.
  • the turmeric component is a first turmeric extract.
  • the first turmeric extract is a 4:1 turmeric extract that is low in curcuminoid content, e.g. 3% or less curcuminoid content.
  • the cinnamon component is selected from cinnamon extract, cinnamon extract powder, and cinnamon powder.
  • the cinnamon component is cinnamon extract.
  • the curcumin component is selected from curcumin extract, curcumin extract powder, and curcumin powder. In an embodiment, the curcumin component is curcumin extract.
  • the curcumin component is a second turmeric extract.
  • the second turmeric extract is a turmeric extract that is high in curcuminoid content, e.g. 95% or greater curcuminoid content.
  • the cinnamon component comprises Cinnamomum cassia.
  • Cinnamomum cassia is known to include free phenolic compounds (Ali et al. 2021 Comprehensive Profiling of Most Widely Used Spices for Their Phenolic Compounds through LC-ESI-QTOF-MS2 and their Antioxidant Potential. Antioxidants 2021, 10, 721. https://doi.org/10.3390/an-tiox10050721 ; Wang et al. 2020.
  • the free phenolic compounds may be present as the below stated compound and/or as one or more derivatives including hydroxy-, methoxy-, and/or glycoside derivatives.
  • Flavan-3-ols both (+)- and/or (-)- isomers: Catechins (7,4'-di-0-methyl-(+)- catechin), Epicatechins (5,7,3'-tri-0-methyl-(-)-epicatechin),
  • Proanthocyanidins A-type (including Cinnamtannins, such as Cinnamtannin B1), Proanthocyanidins, B-type (dimers to >10-mers have been found, including Proanthocyanidin B1) and Other Catechins (including Gallocatechins, Epigallocatechins, Catechin gallates, Epicatechin gallates, and Epigallocatechin gallates).
  • Flavonols Quercetin (Rutin / quercetin-3-O-rutinoside), Myricetin (Myricetin 3-O-rhamnoside), Kaempferol (Kaempferol 3-O-glucosyl- rhamnosylgalactoside) and Isorhamnetin.
  • Flavones Apigenins (Apigenin-7-o-glucoside) and Luteolins (Luteolin-7-o- glucoside).
  • Flavanones Naringenin.
  • Other compounds including Cinnamaldehydes (2-methoxycinnamaldehyde), Coumarins, Curcumin and Demethoxycurcumin.
  • the curcumin and turmeric components comprises Curcuma longa.
  • Curcuma longa is known to include free phenolic compounds (Alafiatayo et al. 2019. Phytochemical Evaluation, Embryotoxicity, and Teratogenic Effects of Curcuma longa Extract on Zebrafish (Danio rerio)", Evidence-Based Complementary and Alternative Medicine, vol. 2019, Article ID 3807207, 10 pages, 2019. https://doi.org/10.1155/2019/3807207; Chumroenphat et al. 2021.
  • the free phenolic compounds may be present as the below stated compound and/or as one or more derivatives including hydroxy- , methoxy-, and/or glycoside derivatives.
  • Phenolic Acids Vanillic acid, Ferulic acids, Syringic acid, Sinapic acid, Caffeic acids, Coumaric acids and Other phenolic acids (including Cinnamic, Gallic, Hydroxybenzoic, Protocatechuic, and other acids).
  • Flavan-3-ols both (+)- and/or (-)- isomers: Catechins, Epicatechins. c. Flavonols: Myricetin (Myricetin 3-0 ⁇ -d-rutinoside), Quercetin (Rutin /
  • Flavones Apigenins (Apigenin 7-O-glucuronide) and Luteolins (Luteolin-7-O- glucoside).
  • Flavanones Naringenin
  • Curcuminoids Curcumin, Bismethoxycurcumin and Demethoxycurcumin.
  • Other Compounds Vanillin and Coumarin.
  • the composition comprises one or more excipients selected from the group consisting of a calcium carbonate granulation, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate, calcium stearate, calcium phosphates, cellulose powder, sodium starch glycolate, maltodextrin, corn starch, methyl cellulose, povidone (polyvinylpyrrolidone), gum Arabic, gelatine, lactose, dextrose, and sucrose (tableting sugar).
  • excipients selected from the group consisting of a calcium carbonate granulation, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate, calcium stearate, calcium phosphates, cellulose powder, sodium starch glycolate, maltodextrin, corn starch, methyl cellulose, povidone (polyvinylpyrrolidone), gum Arabic, gelatine, lactose, dextrose, and suc
  • composition consists of:
  • the composition may be in the form of a tablet, a powder, or a suspension. In an embodiment, the composition is in the form of a tablet. In an embodiment, the composition is in the form of a sustained release tablet. In an embodiment, the composition is in the form of a tablet further comprising a coating.
  • the coating comprises hydroxypropylmethylcellulose (Hypromellose), hydroxyethylcellulose, hydroxypropylcellulose, pharmaceutical/food glaze (shellac), triacetin (glyceryl triacetate), zein, povidone (polyvinylpyrrolidone), polyethylene glycol, cellulose acetate phthalate, methyl acrylate-methacrylic acid copolymers, polyvinyl acetate phthalate, medium chain triglycerides, and glycerin.
  • Hypromellose hydroxypropylmethylcellulose
  • shellac pharmaceutical/food glaze
  • triacetin glyceryl triacetate
  • zein zein
  • povidone polyvinylpyrrolidone
  • polyethylene glycol cellulose acetate phthalate
  • methyl acrylate-methacrylic acid copolymers polyvinyl acetate phthalate
  • medium chain triglycerides and glycerin.
  • composition in the form of a tablet consisting of: [0058] In an embodiment, the composition is in the form of a tablet consisting of:
  • composition in the form of a tablet consisting of:
  • the composition may be in the form of a lozenge e.g. a hard lozenge or a soft lozenge; a bar e.g. a protein bar, an energy bar, a nutritional bar; a blend e.g. an instant tea dry blend; a syrup e.g. a sugar-free syrup; a ready-to-drink tea; a capsule e.g. a soft gelatin capsule or a 2-piece hard shell capsule; or a dry protein mix powder.
  • the composition may be in the form of a soft gelatin capsule comprising vegetable oil, Cinnamon Extract Powder, Turmeric Extract, Yellow Beeswax, Alpha Lipoic Acid and Chromium Yeast.
  • composition may be enclosed in a soft gelatin capsule e.g. a size 14 oblong soft gelatin capsule shell comprising Gelatin, e.g. bovine/porcine/fish/vegetable, Glycerin 99.7% and purified water.
  • a soft gelatin capsule e.g. a size 14 oblong soft gelatin capsule shell comprising Gelatin, e.g. bovine/porcine/fish/vegetable, Glycerin 99.7% and purified water.
  • the composition may be in the form of a hard shell capsule comprising Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid, stearic acid, silicon dioxide and chromium yeast.
  • the composition may be enclosed in a hard shell capsule e.g. a Size #1 bovine/porcine/fish/veggie 2-piece hard shell.
  • the composition may be in the form of a hard lozenge comprising sugar solids, corn syrup solids, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid, chromium yeast, flavourings and colour paste.
  • the composition may be in the form of a soft lozenge comprising polyethylene glycol e.g. polyethylene glycol 1000, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid, chromium yeast, stevia extract, flavourings and colourings.
  • polyethylene glycol e.g. polyethylene glycol 1000, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid, chromium yeast, stevia extract, flavourings and colourings.
  • the composition may be in the form of a sustained release tablet comprising Cinnamon Extract Powder, dicalcium phosphate dihydrate, Turmeric Extract, stearic acid, hydroxypropyl methylcellulose, Alpha Lipoic Acid, chromium yeast, magnesium stearate, silicon dioxide.
  • the composition may be coated with a coating comprising hydroxypropyl methylcellulose, glycerin and purified water.
  • the composition may be in the form of an instant tea dry blend comprising fructose, black tea instant, green tea, flavourings, tea caffeine, honey powder, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid and chromium yeast.
  • the composition may be in the form of a ready to drink tea comprising water, fructose, black tea, green tea, white tea, tea caffeine, stevia, honey powder, citric acid, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid and chromium yeast.
  • the composition may be in the form of a syrup comprising distilled water, glycerin, sorbitol solution, xanthan gum, flavouring, potassium sorbate, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid and chromium yeast.
  • the composition may be in the form of a protein/energy/nutritional bar comprising soy or whey protein crisp, oat fibre, oats, tapioca syrup, pumpkin seeds, raisins, cane juice syrup, cranberries, cashews, almonds, soy protein isolate, brown rice syrup, milled flaxseed, sunflower seeds, sunflower oil, flavourings, blueberries, salt, mixed tocopherols, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid and chromium yeast.
  • a protein/energy/nutritional bar comprising soy or whey protein crisp, oat fibre, oats, tapioca syrup, pumpkin seeds, raisins, cane juice syrup, cranberries, cashews, almonds, soy protein isolate, brown rice syrup, milled flaxseed, sunflower seeds, sunflower oil, flavourings, blueberries, salt, mixed tocopherols, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid and
  • the composition may be in the form of a dry protein mix powder comprising soy protein isolate, whey protein isolate, fructose, soy fibre, oat fibre, calcium/sodium caseinate, milk instant nonfat, guar gum, soluble fibre, lecithin, potassium chloride, dicalcium phosphate anhydrous, flavouring, sodium chloride, safflower oil, magnesium oxide, Cinnamon Extract Powder, Turmeric Extract, cellulose powder, Alpha Lipoic Acid and chromium yeast.
  • carrier includes a diluent, excipient, and/or vehicle with which an active compound is administered.
  • the pharmaceutical compositions of the invention may contain combinations of more than one carrier.
  • Such pharmaceutical carriers can be sterile liquids, such as water, saline solutions, aqueous dextrose solutions, aqueous glycerol solutions, and oils, including those of petroleum, animal, vegetable or synthetic origin, such as peanut oil, soybean oil, mineral oil, sesame oil and the like.
  • an organic solvent such as ethanol, DMA (dimethylacetamide), NMP (N-methyl pyrrolidine), DMSO (dimethyl sulphoxide) etc. may be used alone or in combination with water as a carrier.
  • Water or aqueous solution saline solutions and aqueous dextrose and glycerol solutions are preferably employed as carriers, particularly for injectable solutions.
  • Suitable pharmaceutical carriers are described in “Remington’s Pharmaceutical Sciences” by E.W. Martin, 18 th Edition.
  • pharmaceutically acceptable includes molecular entities and compositions that are generally regarded as safe.
  • pharmaceutically acceptable carriers used in the practice of this invention are physiologically tolerable and do not typically produce an allergic or similar untoward reaction (for example, gastric upset, dizziness and the like) when administered to a patient.
  • pharmaceutically acceptable means approved by a regulatory agency of the appropriate governmental agency or listed in the U.S. Pharmacopoeia or other generally recognized pharmacopoeia for use in animals, and more particularly in humans.
  • a “pharmaceutically acceptable excipient” includes an excipient that is useful in preparing a pharmaceutical composition that is generally safe, non-toxic and neither biologically nor otherwise undesirable, and includes an excipient that is acceptable for veterinary use as well as human pharmaceutical use.
  • a “pharmaceutically acceptable excipient” as used in the present application includes both one and more than one such excipient.
  • the term “treating” includes: (1) preventing the appearance of clinical symptoms of the state, disorder or condition developing in an animal that may be afflicted with or predisposed to the state, disorder or condition but does not yet experience or display clinical or subclinical symptoms of the state, disorder or condition; (2) inhibiting the state, disorder or condition (e.g., arresting, reducing or delaying the development of the disease, or a relapse thereof in case of maintenance treatment, of at least one clinical or subclinical symptom thereof); and/or (3) relieving the condition (i.e., causing regression of the state, disorder or condition or at least one of its clinical or subclinical symptoms).
  • the benefit to a patient to be treated is either statistically significant or at least perceptible to the patient or to the physician.
  • subject includes humans and other mammals, such as domestic animals (e.g., dogs and cats).
  • each component of the combination of the present invention may be administered as the bulk substance(s)
  • it is advantageous to present each ingredient in a pharmaceutical formulation e.g., wherein each agent is in admixture with a pharmaceutically acceptable carrier selected with regard to the intended route of administration and standard pharmaceutical practice.
  • compositions of the present invention are presented in unit dosage form.
  • the composition comprises at least one component of the combination of the invention, and at least one pharmaceutically acceptable excipient or carrier.
  • at least one component of the combination of the invention is present in the composition in a therapeutically effective amount.
  • compositions of the invention may be immediate-release dosage forms, i.e., dosage forms that release the combination (or each component of the combination) at the site of absorption immediately, or controlled-release dosage forms, i.e., dosage forms that release the combination (or each component of the combination) over a predetermined period of time.
  • Controlled release dosage forms may be of any conventional type, e.g., in the form of reservoir or matrix-type diffusion-controlled dosage forms; matrix, encapsulated or enteric-coated dissolution-controlled dosage forms; or osmotic dosage forms. Dosage forms of such types are disclosed, e.g., in Remington, The Science and Practice of Pharmacy, 20 th Edition, 2000, pp. 858-914.
  • the compositions of the present invention can be administered from one to twelve times daily, depending on the dosage form and dosage.
  • compositions comprising a combination of the invention (or each component of the combination) adapted for use in human or veterinary medicine.
  • Such compositions may be presented for use in a conventional manner with the aid of one or more suitable carriers.
  • Acceptable carriers for therapeutic use are well known in the pharmaceutical art, and are described, for example, in Remington’s Pharmaceutical Sciences, Mack Publishing Co. (A. R. Gennaro edit. 1985).
  • the choice of pharmaceutical carrier can be selected with regard to the intended route of administration and standard pharmaceutical practice.
  • the pharmaceutical compositions may comprise as, in addition to, the carrier any suitable binder(s), lubricant(s), suspending agent(s), coating agent(s), and/or solubilising agent(s).
  • Preservatives, stabilizers, dyes and even flavouring agents may be provided in the pharmaceutical composition.
  • preservatives include sodium benzoate, ascorbic acid and esters of p-hydroxybenzoic acid.
  • Antioxidants and suspending agents may also be used.
  • the combinations of the present invention may be milled using known milling procedures such as wet milling to obtain a particle size appropriate for tablet formation and for other formulation types.
  • Finely divided (nanoparticulate) preparations of the compounds may be prepared by processes known in the art, see, e.g., International Patent Application No. WO 02/00196 (SmithKIine Beecham).
  • Suitable examples of pharmaceutically acceptable buffers useful herein include, but are not limited to, citric acid, sodium citrate, sodium bicarbonate, dibasic sodium phosphate, magnesium oxide, calcium carbonate and magnesium hydroxide.
  • Suitable examples of pharmaceutically acceptable surfactants useful herein include, but are not limited to, sodium lauryl sulfate and polysorbates.
  • Suitable examples of pharmaceutically acceptable preservatives include, but are not limited to, various antibacterial and antifungal agents such as solvents, for example ethanol, propylene glycol, benzyl alcohol, chlorobutanol, quaternary ammonium salts, and parabens (such as methyl paraben, ethyl paraben, propyl paraben, etc.).
  • Suitable examples of pharmaceutically acceptable stabilizers and antioxidants include, but are not limited to, ethylenediaminetetraacetic acid (EDTA), thiourea, tocopherol and Butyl hydroxyanisole.
  • compositions of the invention may contain from 0.01 to 99% weight per volume of the combinations encompassed by the present invention (or each component of the combinations of the invention).
  • Appropriate patients to be treated according to the methods of the invention include any human or animal in need of such treatment.
  • Methods for the diagnosis and clinical evaluation of the disease condition including its severity in an animal or human will be well known in the art.
  • the patient is preferably a mammal, more preferably a human, but can be any subject or animal, including a laboratory animal in the context of a clinical trial, screening, or activity experiment employing an animal model.
  • the methods and compositions of the present invention are particularly suited to administration to any animal or subject, particularly a mammal, and including, but not limited to, domestic animals, such as feline or canine subjects, farm animals, such as but not limited to bovine, equine, caprine, ovine, and porcine subjects, research animals, such as mice, rats, rabbits, goats, sheep, pigs, dogs, cats, etc., avian species, such as chickens, turkeys, songbirds, etc.
  • domestic animals such as feline or canine subjects
  • farm animals such as but not limited to bovine, equine, caprine, ovine, and porcine subjects
  • research animals such as mice, rats, rabbits, goats, sheep, pigs, dogs, cats, etc.
  • avian species such as chickens, turkeys, songbirds, etc.
  • a physician or integrative medicine provider will determine the actual dosage which will be most suitable for an individual subject.
  • the specific dose level and frequency of dosage for any particular individual may be varied and will depend upon a variety of factors including the activity of the specific compound employed, the metabolic stability and length of action of that compound, the age, body weight, general health, sex, diet, mode and time of administration, rate of excretion, drug combination, the severity of the particular condition, and the individual undergoing therapy.
  • a suitable therapeutically effective and safe dosage can be administered to subjects.
  • the daily dosage level of the composition may be in single or divided doses.
  • the duration of treatment may be determined by one of ordinary skill in the art, and should reflect the nature of the condition and/or the rate and degree of therapeutic response to the treatment. Typically, a physician will determine the actual dosage which will be most suitable for an individual subject.
  • the specific dose level and frequency of dosage for any particular individual may be varied and will depend upon a variety of factors including the activity of the specific compound employed, the metabolic stability and length of action of that compound, the age, body weight, general health, sex, diet, mode and time of administration, rate of excretion, drug combination, the severity of the particular condition, and the individual undergoing therapy.
  • Example 1 the impact of the formulations of the present invention on glycemic control in older adults.
  • OGTT oral glucose tolerance test
  • the stable baseline design allows smaller samples to be used. Essentially the start of treatment occurs at different times. Thus, if there is a consistent finding that a change occurs in different groups when the treatment started, it may be concluded that the change reflects the treatment rather than a chance factor. If there is a significant change in all participants, it may be concluded that the treatment is effective. This design can establish the time needed for an effect to occur, given that some previous studies have looked only after three months of administration.
  • the primary outcome measure will be area under the curve from the OGTT. Detailed procedure
  • Figure 3 demonstrates that levels of triglycerides (mg/dl +/- SE) fell when taking the supplement: baseline to month 2 (p ⁇ 0.002) and month 3 (p ⁇ 0.015). With the placebo there was a significant increase at month 3 (p ⁇ 0.041). The subjects were those with poor glucose tolerance.
  • Hemoglobin A1c is the protein in the red blood cells that carries oxygen around the body. HbA1c is an average measure of the level of blood glucose over the previous three months (the time it takes for red blood cells to turnover). The greater the level of blood sugar, the higher the HbA1c.
  • HbA1c less than 6% is good; 6-6.4% pre-diabetic; over 6.5% diabetic.
  • the data are total cholesterol as mg/dL (standard deviation) in those who at baseline had a HbA1c > 5.9% (that is blood glucose levels are above recommended levels). A cholesterol value of less than 200 mg/dL is considered good.
  • Ingredients are placed into suitable rotary blender in specified order and mixed for a proscribed and validated amount of time to ensure thorough blending. Prior to charging into the rotary blender, all ingredients are passed through a US Standard 12 Mesh screen. Certain ingredients may be milled using a suitable rotary hammer mill prior to charging into the rotary blender. The blended product is discharged into clean, polybag lined, tared, labeled drums. Total blended weight is recorded and verified.
  • the blended batch is compressed into oval shaped tablets using a suitable rotary tablet press with compression force and die table rotation speed set to produce tablets of acceptable weight, thickness and shape.
  • tablet samples are removed, and critical quality parameters are measured - tablet weight, thickness, hardness and friability.
  • Compressed tablets are discharged into clean, polybag lined, tared, labeled drums. Total compressed tablet batch weight is recorded and verified. Compressed tablet samples are taken for QC lab testing.
  • the compressed tablets are coated in a suitable perforated pan spray coater with an aqueous solution of a modified cellulosic polymer mixed with an appropriate plasticizer.
  • Coater air temperature, pan rpm speed, venturi spray gun air pressure and spray fan shape are set at predetermined and validated settings to ensure complete, even and acceptable coating of all tablets charged into the coating pan.
  • the spray time is set at a predetermined, validated setting that ensures all tablets are coated to a specific coating thickness.
  • Coated tablets are discharged into clean, polybag lined, tared, labeled drums. Total coated tablet batch weight is recorded and verified. Coated tablet samples are taken for QC lab testing and for batch retain.
  • Test formulation according to the invention Example 6 - Additional formulations
  • Figure 8 shows that the exposure to increasing concentrations of SPB in THP-1 cells for 24 hours did not induce any sign of toxicity, as assessed by the MTT assay, a widely used method to evaluate the mitochondrial activity of living cells and hence their viability. This test is widely used in the in vitro evaluation of the biosafety of plant extracts. (Saad B, Abu-Hijleh G, Suter UW. Polymer biocompatibility assessment by cell culture techniques. In: Arshady R (ed). The PMB Series Volume 1: Introduction Polymeric Biomaterials. The Citus Books, 2003, 263-99).

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Abstract

La présente invention concerne une composition comprenant (a) un composant de cannelle ; et (b) un composant de curcuma et/ou de curcumine ; pour une utilisation dans le traitement, la progression ou la prévention (i) d'une maladie ou d'une affection liée à une mauvaise régulation du glucose sanguin ; (ii) d'une maladie ou d'une affection liée à un état d'inflammation chronique à faible niveau de progression ; et/ou (iii) d'une maladie ou d'une affection pouvant être traitée par réduction des taux de triglycérides.
PCT/IB2021/054699 2020-05-29 2021-05-28 Compléments alimentaires WO2021240461A1 (fr)

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