SEL DE CALCIUM-POTASSIUM D'ACIDE HYDROXYCITRIQUE

Si vous avez besoin d’aide pour accéder aux formats de rechange, tels que Portable Document Format (PDF), Microsoft Word et PowerPoint (PPT), visitez la section d’aide sur les formats de rechange.

La présente monographie vise à servir de guide à l'industrie pour la préparation de demandes de licence de mise en marché (DLMM) et d'étiquettes dans le but d'obtenir une autorisation de mise en marché d'un produit de santé naturel. Elle ne vise pas à être une étude approfondie de l'ingrédient médicinal.

Nota

• Les parenthèses contiennent des éléments d’information additionnels (facultatifs) qui peuvent être inclus dans la DLMM ou sur l’étiquette du produit à la discrétion du demandeur.
• La barre oblique (/) indique que les termes ou les énoncés sont synonymes. Le demandeur peut utiliser n’importe lequel des termes ou énoncés indiqués.

Date

31 juillet 2018

Nom(s) propre(s), Nom(s) commun(s), Matière(s) d'origine

Tableau 1. Nom(s) propre(s), Nom commun(s), Matière(s) d'origine

Nom(s) propre(s)	Nom(s) commun(s)	Matière(s) d'origine
		Nom(s) propre(s)	Nom(s) commun(s)	Partie(s)	Préparation(s)
Sel de calcium/potassium d'acide hydroxycitrique Sel de calcium-potassium d'acide (-)-hydroxycitrique	Sel de calcium/potassium d'acide hydroxycitrique Sel de calcium-potassium d'acide (-)-hydroxycitrique	Garcinia gummi-guta	N/A	Pelure de fruit
		N/A	Sel de calcium-potassium d'acide (-)-hydroxycitrique	N/A	Synthétique

Références: Noms propres: Preuss et al. 2004a, Preuss et al. 2004b; Noms communs: Preuss et al. 2004a, Preuss et al. 2004b; Matières d'origine: Hayamizu et al. 2008, Preuss et al. 2004a, Preuss et al. 2004b.

Voie d'administration

Orale

Forme(s) posologique(s)

Cette monographie exclut les aliments et les formes posologiques semblables aux aliments tel qu’indiqué dans le document de référence Compendium des monographies.

Les formes posologiques acceptables pour les catégories d’âge listées dans cette monographie pour la voie d'administration spécifiée sont indiquées dans le document de référence Compendium des monographies.

Usage(s) ou fin(s)

Pourrait aider à augmenter temporairement la sensation de satiété/d'être rassasié (Westerterp-Plantega et Kovacs 2002).

Dose(s)

Sous-population

Adultes 18 ans et plus

Quantité(s)

1500 à 5000 milligrammes, par jour; Ne pas dépasser 500 à 2000 milligrammes par dose unique (Preuss et al. 2004a; Preuss et al. 2004b; Westerterp-Plantega et Kovacs 2002).

Activité :

• 60 % d'acide hydroxycitrique
• 11 % de calcium
• 16 % de potassium

Mode(s) d'emploi

Prendre avant les repas, quelques heures avant ou après la prise d'autres médicaments ou produits de santé naturels (Martindale 2009; ASHP 2005; CPhA 2001).

Durée(s) d'utilisation

Énoncé non requis.

Mention(s) de risque

Précaution(s) et mise(s) en garde

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant d’en faire l’usage si vous êtes enceinte ou si vous allaitez.

Contre-indication(s)

Produits fournissant de 350 à 747 mg de potassium par jour ou plus de 200 mg de potassium par dose :

Ne pas utiliser ce produit si vous souffrez d’obstruction ou d’ulcération gastro-intestinale (Martindale 2009; CPhA 2001).

Réaction(s) indésirable(s) connue(s)

Produits fournissant de 350 à 747 mg de potassium par jour ou plus de 200 mg de potassium par dose :

Peut causer des nausées, des vomissements ou des crampes abdominales; cesser l’utilisation et consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si les symptômes sont sévères (Martindale 2009; CPhA 2001).

Ingrédients non médicinaux

Doivent être choisis parmi ceux de la version actuelle de la Base de données des ingrédients des produits de santé naturels (BDIPSN) et respecter les restrictions mentionnées dans cette base de données.

Conditions d'entreposage

Énoncé non requis.

Spécifications

• Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la Direction des produits de santé naturels et sans ordonnance (DPSNSO).
• L'ingrédient médicinal doit être conforme aux exigences mentionnées dans la (BDIPSN).

Références citées

• ASHP 2005 : American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005
• CPhA 2001: Canadian Pharmacists Association. Compendium of Nonprescription Products: Companion to CPS. Ottawa (ON): Canadian Pharmacists Association; 2001
• Hayamizu K, Tomi H, Kaneko I, Shen M, Soni MG, Yoshino G. Effects of Garcinica cambogia extract on serum sex hormones in overweight subjects. Fitoterapia 2008; 79: 255-261
• Martindale 2009: Sweetman SC (ed), Martindale:  The Complete Drug Reference. [Internet] London (GB): Pharmaceutical Press; Copyright 1933-2010. [Consulté le 14 juin 2018].
• Preuss HG, Bagchi D, Bagchi M, Rao CVS, Dey DK, Satyanarayana S. Effects of a natural extract of (-)-hydroxycitric acid (HCA-SX) and a combination of HCA-SX plus niacin-bound chromium and Gymnema sylvestre extract on weight loss. Diabetes, Obesity and Metabolism 2004a; 6: 171-180
• Preuss HG, Bagchi D, Bagchi M, Rao CVS, Satyanarayana S, Dey DK. Efficacy of a novel, natural extract of (-)-hydroxycitrica acid (HCA-SX) and a combination of HCA-SX, niacin-bound chromium and Gymnema sylvestre extract in weight management in human volunteers: A pilot study. Nutrition Research 2004b; 24: 45-58
• Westerterp-Plantenga MS, Kovacs EMR. The effect of (-)-hydroxycitrate on energy intake and satiety in overweight humans. International Journal of Obesity. 2002; 870-872

Références consultées

• Antonio J, Colker M, Torina GC, Shi Q, Brink W, Kalman D. Effects of a standardized guggulsterone phosphate supplement on body composition in overweight adults: a pilot study. Current Therapeutic Research 1999; 60: 220-227
• ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005
• Asghar M, Monjok E, Kouamou G, Ohia SE, Bagchi D, Lokhandwala MF. Super CitriMax (HCA-SX) attenuates increases in oxidative stress, inflammation, insulin resistance, and body weight in developing obese Zucker rats. Molecular and Cellular Biochemistry 2007; 304(1-2): 93-99
• Badmaev V, Majeed M. Open field, physician controlled, clinical evaluation of botanical weight loss formula citrin. Presented at: Nutracon 1995: Nutriceuticals, Dietary Supplements and Functional Foods; July 11-13, 1995; Las Vegas, Nev. [tel que revu dans Heymsfield et al. 1998 et Soni et al. 2004]
• Behne D, Kyriakopoulos A, Gessner H, Vormann J, Gunther T. Sex-related effects of zinc deficiency on the selenium metabolism in rats. Journal of trace elements and electrolytes in health and disease 1992 Mar;6(1):21-5.
• Burdock G, Bagchi M. Letter to the editor: Garcinia cambogia toxicity is misleading. Food and Chemical Toxicology 2005; 43: 1683-1684
• Brinker F. 2010.  Final updates and additions for Herb Contraindications and Drug Interactions, 3^rd edition. including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Consulté le 9 janvier 2012].
• Brinker F. Herb Contraindications and Drug Interactions. 3^rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
• Cheema-Dhadli S, Halperin ML, Leznoff CC: Inhibition of enzymes which interact with citrate by (-)hydroxycitrate and 1,2,3,- tricarboxybenzene. European journal of biochemistry 1973, 38:98-102.
• Conte AA. A non-prescription alternative on weight reduction therapy. American Journal of Bariatric Medicine. Summer 1993:17-19. [tel que revu dans Heymsfield et al. 1998; Jena et al. 2002; Soni et al. 2004]
• Conte AA. How I do it in my bariatric practice: A non-prescription alternative in weight reduction therapy. Bariatrician. 1993:7-19. [tel que revu dans Kriketos et al. 1999]
• Conte AA. The effects of (-)-hydroxycitrate and chromium (GTF) on obesity. Journal of the American College of Nutrition 1994: 13: 535 [Résumé 60]
• Downs BW, Bagchi M, Subbaraju GV, Shara MA, Preuss HG, Bagchi D. Bioefficacy of a novel calcium-potassium salt of (-)-hydroxycitric acid. Mutation Research 2005; 579(1-2): 149-162
• Fukuoka M, Kobayashi T, Hayakawa T. Mechanism of testicular atrophy induced by di-n-butyl phthalate in rats. Part 5. Testicular iron depletion and levels of ferritin, haemoglobin and transferrin in the bone marrow, liver and spleen. Journal of Applied Toxicology 1995 Sep-Oct;15(5):379-86
• Gatta B, Zuberbuehler C, Arnold M, Aubert R, Langhans W, Chapelot D. Acute effects of pharmacological modifications of fatty acid metabolism on human satiety. British Journal of Nutrition 2009; 101: 1867-1877
• Girola M, De Bernardi M, Contos S, et al. Dose effect in lipid-lowering activity of a new dietary integrator (chitosan, Garcinia cambogia extract, and chrome). Acta Toxicol Ther. 1996; 17:25-40 [tel que revu dans Heymsfield et al. 1998 et Soni et al. 2004]
• Glykon Technologies Group, LCC.  Inherent Safety of HCA Salts. 2006 [Consulté le 11 juillet 2012].
• Graff L, Muller G, Burnel D. In vitro and in vivo evaluation of potential aluminum chelators. Veterinary and Human Toxicology. 1995;37(5):455-461.
• HC 2011: Health Canada. Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Consulté le 9 janvier 2012].
• Hayamizu K, Ishii Y, Kaneko I, Shen M, Sakaguchi H, Okuhara Y, Shigematsu N, Miyazaki S, Shimaski H. Effects of long-term administration of Garcinia cambogia extract on visceral fat accumulation in humans: A placebo-controlled double blind trial. Journal of Oleo Science 2001; 50(10): 805-812
• Hayamizu K, Ishii Y, Kaneko I, Shen M, Okuhara Y, Sakaguchi H, SHigematsu N, Shimasaki H. No-observed-adverse-effect level (NOAEL) and sequential-high-doses administration study on Garcinia cambogia extract in humans. Journal of Oleo Science 2002; 51: 365-9
• Hayamizu K, Ishii Y, Shigematsu N, Okuhara Y, Tomi H, Furuse M, Yoshino G, Shimasaki H. Safety of Garcinia cambogia extract in healthy men: high-doses administration study I. Journal of Oleo Science. 2003a; 52(9): 499-504
• Hayamizu K, Ishii Y, Kaneko I, Shen M, Okuhara Y, Shigematsu N, Tomi H, Furuse M, Yoshino G, Shimasaki H. Effects of Garcinia cambogia (Hydroxycitric acid) on visceral fat accumulation: A double-blind, randomized, placebo-controlled trial. Current Therapeutic Research 2003b; 64 (8): 551-567
• Heymsfield SB, Allison DB, Vasselli JR, Pietrobelli A, Greenfield D, Nunez C. Garcinia cambogia (Hydroxycitric acid) as a potential antiobesity agent, a randomized controlled trial. Journal of the American Medical Association 1998; 280(18): 1596-1600
• IOM 2005: Institute of Medicine. Panel on Dietary Reference Intakes for Electrolytes and Water, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington (DC): National Academies Press.
• Ishii Y, Kaneko I, Shen M, Hayamizu K, Shigematsu N, Tomi H, Yoshino G, Shimaski H. Safety of Garcinia cambogia extract in healthy volunteers: High-dose administration study II. Journal of Oleo Science 2003; 52(12): 663-671
• Jena BS, Jayaprakasha GK, Singh RP, Sakariah KK. Chemistry and biochemistry of (-)-hydroxycitric acid from Garcinia. Journal of agricultural and food chemistry 2002; 50: 10-22
• Kaats G, Pullin D, Parker L, Keith S. 1996 [tel que revu dans Heymsfield et al. 1998 et Soni et al. 2004]
• Kim JE, Jeon SM, Park KH, Lee WS, Jeong TS, McGregor RA, Choi MS. Does Glycine max leaves or Garcinia Cambogia promote weight-loss or lower plasma cholesterol in overweight individuals: a randomized control trial. Nutrition Journal 2011; 10: 94
• Kiyose C, Ogino S, Kubo K, Takeuchi M, Saito M. Relationship between Garcinia cambogia-induced impairment of spermatogenesis and meiosis-activating sterol production in rat testis. Journal of clinical biochemistry and nutrition 2006; 38: 180-187
• Kovacs EMR, Westerterp-Plantenga MS. Effects of (-)-hydroxycitrate on net fat synthesis as de novo lipogenesis. Physiology & Behaviour 2006; 88(4-5): 371-381
• Kovacs EM, Westerterp-Plantenga MS, Saris WH. The effects of 2-week ingestion of (-)-hydroxycitrate and (-)-hydroxycitrate combined with medium-chain triglycerides on satiety, fat oxidation, energy expenditure and body weight. International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity 2001a; 25(7): 1087-94
• Kriketos AD, Thompson HR, Greene H, Hill JO. (-)-hydroxycitric acid does not affect energy expenditure and substrate oxidation in adult males in a post-absorptive state. International Journal of Obesity 1999; 23: 867-873
• Lewis YS, Neelakantan S. (-)-Hydroxycitric acid - the principal acid in the fruits of Garcinia cambogia. Phytochemistry 1965; 4: 619-625
• Lim K, Ryu S, Nho HS, Choi SK, Kwon T, Suh H, So J, Tomita K, Okuhara Y, Shigematsu N. (-)-Hydroxycitric acid ingestion increases fat utilization during exercise in untrained women. Journal of Nutritional Science and Vitaminology (Tokyo) 2003; 49(3): 163-7
• Lim K, Ryu S, Ohishi Y, Watanabe I, Tomi H, Suh H, Lee WK, Kwon T. Short-term (-)-hydroxycitrate ingestion increases fat oxidation during exercise in athletes. Journal of Nutritional Science and Vitaminology (Tokyo). 2002; 48(2): 128-33
• Louter-van de Haar J, Wielinga PY, Scheurink AJW, Nieuwenhuizen AG. Comparison of the effects of three different (-)-hydroxycitric acid preparations on food intake in rats. Nutrition and Metabolism. 2005; 2: 23
• Mansi IA, Huang J. Rhabdomyolysis in response to weight-loss herbal medicine. The American Journal of the Medical Sciences. 2004; 327(6): 356-7
• Márquez F, Babio N, Bulló M, Salas-Salvadó J. Evaluation of the safety and efficacy of hydroxycitric acid or Garcinia cambogia extracts in humans. Critical Reviews in Food Science and Nutrition 2012; 52(7): 585-594
• Mattes RD, Bormann L. Effects of (-)-hydroxycitric acid on appetite variables. Physiology & Behaviour 2000; 71: 87-94
• Meachem SJ, Nieschlag E, Simoni M. Inhibin B in male reproduction: pathophysiology and clinical relevance. European Journal of Endocrinology. 2001; 145: 561-571
• Michno A, Skibowska A, Raszeja-Specht A, Cwikowska J, Szutowicz A. The role of adenosine triphosphate citrate lyase in the metabolism of acetyl coenzyme a and function of blood platelets in diabetes mellitus. Metabolism 2004; 53(1): 66-72
• Natural Standard. Garcinia (Garcinia cambogia L.), Hydroxycitric acid. Natural Standard Professional Monograph. Natural Standard Inc; 2012 [Consulté le 11 juillet 2012]..
• Natural Standard. Hydroxycitric acid. Natural Standard Professional Monograph. Natural Standard Inc; 2012 [Consulté le 11 juillet 2012]..
• Opala T, Rzymski P, Pischel I, Wilczak M, Wozniak J. Efficacy of 12 weeks supplementation of a botanical extract-based weight loss formula on body weight, body composition and blood chemistry in healthy, overweight subjects - A randomised double-blind placebo-controlled clinical trial. European Journal of Medicinal Research. 2006; 11: 343-350
• Pierik F, Burdorf A, de Jong F, Weber R. Inhibin B: a novel marker of spermatogenesis. Annals of Medicine 2003; 35(1): 12-20
• Preuss HG, Bagchi D, Rao CVS, Echard BW, Satayanarayana S, Bagchi M. Effect of hydroxycitric acid on weight loss, body mass index and plasma leptin levels in human subjects. FASEB Journal 2002; 16, A1020 [tel que revu dans Soni et al. 2004]
• Preuss HG, Garis RI, Bramble JD, Bagchi D, Bagchi M, Rao CV, Satyanarayana S. Efficacy of a novel calcium/potassium salt of (-)-hydroxycitric acid in weight control. International Journal of Clinical Pharmacology Research 2005; 25(3); 133-44
• Ramos R, Flores Saenz J, Alarcon D. 1996 [tel que revu dans in Heymsfield et al. 1998]
• Ramos RR, Saenz JL, Aguilar CF. Extract of Garcinia cambogia in the control of obesity [in Spanish]. Investigacion medica International 1995; 22; 97-100 [tel que revu dans Soni et al. 2004 et Preuss et al. 2004]
• Rothacker DQ, Waitman BE. Effectiveness of a Garcinia cambogia and natural caffeine combination in weight loss: a double-blind placebo-controlled pilot study. International Journal of Obesity 1997;21(suppl 2):53. [tel que revu dans Heymsfield et al. 1998 et Soni et al. 2004]
• Saito M, Ueno M, Ogino S, Kubo K, Nagata J, Takeuchi M. High dose Garcinia cambogia is effective in suppressing fat accumulation in developing male Zucker obese rats, but is highly toxic to the testis. Food and Chemical Toxicology 2005; 43: 411-419
• SC 2011: Santé Canada.  Base de données en ligne des effets indésirables de Canada Vigilance. Ottawa (ON): Direction des produits de santé commercialisés, Santé Canada; 2011. [Consulté le 9 janvier 2012].
• Shara M, Ohia SE, Schmidt RE, Yasmin T, Zardetto-Smith A, Kincaid A, Bagchi M, Chatterjee A, Bagchi D, Stohs SJ. Dose- and time-dependent effects of a novel (-)-hydroxycitric acid extract on body weight, hepatic and testicular lipid peroxidation, DNA fragmentation and histopathological data over a period of 90-days. Molecular and Cellular Biochemistry 2003; 254, 339-346
• Shara M, Ohia SE, Schmidt RE, Yasmin T, Zardetto-Smith A, Kincaid A, Bagchi M, Chatterjee A, Bagchi D, Stohs SJ Physico-chemical properties of a novel ()-hydroxycitric acid extract and its dose- and time-dependent effects on body weight, selected organ weights, hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, and histopathological changes over a period of 90-days. Molecular and Cellular Biochemistry 2004; 260, 171-186
• Soni MG, Burdock GA, Preuss HG, Stohs SJ, Ohia SE, Bagchi D. Safety assessment of (-)-hydroxycitric acid and Super CitriMax®, a novel calcium/potassium salt. Food and Chemical Toxicology 2004; 42: 1513-1529
• Thom E. A randomized, double-blind, placebo-controlled trial of new weight-reducing agent of natural origin. The Journal of International Medical Research 2000; 28: 229-233
• Thom E. Hydroxycitrate (HCA) in the treatment of obesity. International Journal of Obesity 1996; 20(suppl 4): 48 [tel que revue dans Heymsfield et al. 1998; Jena et al. 2002; Soni et al. 2004]
• Tomita K, Okuhara Y, Shigematsu N, Suh H, Lim K. (-)-Hydroxycitrate ingestion increases fat oxidation during moderate intensity exercise in untrained men. Biosci Biotechnol Biochem 2003; 67(9): 1999-2001
• Toromanyan E, Aslanyan G, Arroyan E, Gabrielyan E, Panossian A. Efficacy of Slim339 in reducing body weight of overweight and obese human subjects. Phytotherapy Research 2007; 21: 1177-1181
• Westerterp-Plantenga MS, Kovacs EMR. The effect of (-)-hydroxycitrate on energy intake and satiety in overweight humans. International Journal of Obesity. 2002; 870-872
• van Loon LJC, van Rooijen JJM, Niesen B, Verhagen H, Saris WHM, Wagenmakers AJM. Effects of acute (-)-hydroxycitrate supplementation on substrate metabolism at rest and during exercise in humans. American Journal of Clinical Nutrition. 2000; 72: 1445-14450
• Vasques CA, Rossetto S, Halmenschlager G, Linden R, Heckler E, Fernandez MS, Alonso JL. Evaluation of the pharmacotherapeutic efficacy of Garcinia cambogia plus Amorphophallus konjac for the treatment of obesity. Phytotherapy Research 2008; 22(9): 1135-40
• Venkateswara Rao G, Karunakara AC, Santhosh Babu RR, Ranjit D, Chandrasekara Reddy G. Hydroxycitric acid lactone and its salts: preparation and appetite suppression studies. Food Chemistry 2010; 120: 235-239