GLUCOMANNAN
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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.
Notes
- Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
- The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
Date
December 30, 2022
Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | |||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||
Glucomannan |
Glucomannan |
|
Tuber |
Isolate |
References: Proper name: NIH 2019, O'Neil et al. 2009; Common names: NIH 2019, Chua et al. 2010, O'Neil et al. 2009; Source information: USDA 2019, O'Neil et al. 2009.
Route of administration
Oral
Dosage Form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
The acceptable dosage forms are limited to capsules and powder.
Use(s) or Purpose(s)
- Helps to lower cholesterol levels (by reducing cholesterol absorption from the gastrointestinal tract) (EFSA 2009; Sood et al. 2008; Martino et al. 2005; Chen et al. 2003; Arvill and Bodin 1995; Walsh et al. 1984).
- (Used in Herbal Medicine as a) bulk-forming laxative (Chua et al. 2010; Chen et al. 2008; Chen et al. 2006; González Canga et al. 2004; Loening-Baucke et al. 2004).
- (Used in Herbal Medicine to) promote(s) bowel movements (by increasing bulk volume and water content) (Chua et al. 2010; Chen et al. 2008; Chen et al. 2006; González Canga et al. 2004; Loening-Baucke et al. 2004).
- (Used in Herbal Medicine to) provide(s) gentle relief of constipation and/or irregularity (Chua et al. 2010; Chen et al. 2008; Chen et al. 2006; González Canga et al. 2004; Loening-Baucke et al. 2004).
The following combined use(s) or purpose(s) is/are also acceptable:
(Used in Herbal Medicine as a) bulk-forming laxative to provide gentle relief of constipation or irregularity and promote bowel movements (by increasing bulk volume and water content) (Chua et al. 2010; Chen et al. 2008; Chen et al. 2006; González Canga et al. 2004; Loening-Baucke et al. 2004).
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Lowering of cholesterol
1 - 1.5 grams of glucomannan, 3 times per day (EFSA 2009; Martino et al. 2005; Chen et al. 2003; Arvill and Bodin 1995; Walsh et al. 1984)
Laxative; Promotion of bowel movement; Constipation relief
0.5 - 5 grams of glucomannan, 3 times per day (Chen et al. 2008; Chen et al. 2006; González Canga et al. 2004; Loening-Baucke et al. 2004)
Direction(s) for use
All products
- Take 2 hours before or after taking other medications or natural health products (Sweetman 2007; Keithley and Swanson 2005).
- Taking this product with insufficient liquid may result in choking, or blockage/obstruction of the throat, esophagus or intestine (FDA 2009; Sweetman 2007; Vanderbeek et al. 2007; Henry et al. 1986).
- Take during the day (not immediately prior to bedtime) (Sweetman 2007).
Lowering of cholesterol
Take 0.5-1 hour before meals (Chen et al. 2003; Arvill and Bodin 1995; Walsh et al. 1984).
Laxative; Promotion of bowel movement; Constipation relief
- Take with meals (Chen et al. 2008; Chen et al. 2006; González Canga et al. 2004; Loening-Baucke et al. 2004).
- Effects observed 12-24 hours after first dose, but may take 2-3 days (Berardi et al. 2002).
Optional: For products with a dosage range
- Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
For capsules
Take with at least 240 milliliters of liquid (e.g. water, milk, fruit juice or other similar beverage) (FDA 2018; Martino et al. 2005; Chen et al. 2003; Arvill and Bodin 1995; Walsh et al. 1984).
For powder
For each gram of glucomannan, mix well with at least 240 milliliters of liquid (e.g. water, milk, fruit juice or other similar beverage). Stir briskly and drink immediately. Maintain adequate fluid intake (FDA 2018).
Duration(s) of use
Cholesterol-lowering products
Consult a healthcare practitioner/health care provider/health care professional/doctor/physician for use beyond 8 weeks (Martino et al. 2005; Walsh et al. 1984).
Risk Information
Caution(s) and warning(s)
All products
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have diabetes (Chen et al. 2003; Vuksan et al. 2001).
Laxative; Promotion of bowel movement; Constipation relief
- Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen or if laxative effect does not occur within 7 days (Pray 2006; Repchinsky 2002).
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are experiencing a sudden change in bowel habits that has persisted for more than 2 weeks, undiagnosed rectal bleeding, or have failed to defecate following the use of a laxative product (Pray 2006).
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have symptoms such as abdominal pain, nausea, vomiting or fever (as these could be signs of other serious conditions) (Pray 2006; Berardi et al. 2002).
Contraindication(s)
Do not use this product if you have difficulty swallowing (FDA 2018; Sweetman 2007; Vanderbeek et al. 2007; Henry et al. 1986).
Known adverse reaction(s)
- Seek immediate medical attention if you experience chest pain, vomiting, or difficulty swallowing or breathing after taking the product (FDA 2018).
- May cause temporary gas and/or bloating (Sood et al. 2008).
Non-medicinal ingredients
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
Storage conditions
Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).
Specifications
- The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
- The medicinal ingredient must comply with the requirements outlined in the NHPID.
References Cited
- Arvill A, Bodin L. 1995. Effect of short-term ingestion of konjac glucomannan on serum cholesterol in healthy men. American Journal of Clinical Nutrition 61(3):585-589.
- Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self- Care, 13th edition. Washington (DC): American Pharmaceutical Association.
- Chen HL, Cheng HC, Wu WT, Liu YJ, Liu SY. 2008. Supplementation of konjac glucomannan into a low-fibre Chinese diet promoted bowel movement and improved colonic ecology in constipated adults: a placebo-controlled, diet controlled trial. Journal of the American College of Nutrition 27:102-108.
- Chen HL, Cheng HC, Liu YJ, Liu SY, Wu WT. 2006. Konjac acts as a natural laxative by increasing stool bulk and improving colonic ecology in healthy adults. Nutrition 22:1112-1119.
- Chen HL, Sheu WH, Tai TS, Liaw YP, Chen YC. 2003. Konjac supplement alleviated hypercholesterolemia and hyperglycemia in type 2 diabetic subjects—a randomized double-blind trial. Journal of American College of Nutrition 22(1):36-42.
- Chua M, Baldwin TC, Hocking TJ, Chan K. 2010. Traditional uses and potential health benefits of Amorphophallus konjac K. Koch ex N.E.Br. Journal of Ethnopharmacology 128(2):268-278.
- EFSA 2009: European Food Safety Authority. 2009. EFSA Panel on Dietetic Products, Nutrition and Allergies; Scientific Opinion on the substantiation of health claims related to glucomannan and maintenance of normal blood cholesterol concentrations (ID 836, 1560) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 7(9): 1258. doi:10.2903/j.efsa.2009.1258. [Accessed 2019 July 5]. Available from: www.efsa.europa.eu.
- FDA 2018: United States Food and Drug Administration. 2018. Specific Labeling Requirements for Specific Drug Products. Code of Federal Regulations Title 21, Volume 4 (21CFR201.319). Rockville (MD): United States Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2019 July 5]. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.319
- González Canga A, Fernández Martínez N, Sahagún AM, García Vieitez JJ, Díez Liébana MJ, Calle Pardo AP, Castro Robles LJ, Sierra Vega M. 2004. Glucomanano: propiedades y aplicaciones terapéuticas [Glucomannan: properties and therapeutic applications] Nutrición Hospitalaria 19(1):45-50.
- Henry DA, Mitchell AS, Aylward J. 1986. Glucomannan and risk of esophageal obstruction. British Medical Journal 292:591-592.
- Keithley J, Swanson B, 2005. Glucomannan and obesity: a critical review. Alternative Therapies in Health and Medicine 11:30-34.
- Loening-Baucke V, Miele E, Staiano A. 2004. Fiber (glucomannan) is beneficial in the treatment of childhood constipation. Pediatrics 113(3 Pt 1):e259-e264.
- Martino F, Martino E, Morrone F, Carnevali E, Forcone R, Niglio T. 2005. Effect of dietary supplementation with glucomannan on plasma total cholesterol and low density lipoprotein cholesterol in hypercholesterolemic children. Nutrition, Metabolism & Cardiovascular Diseases (3):174-180.
- NIH 2019: National Institutes of Health. ChemIDplus advanced [online]. Glucomannan. Bethesda (MD): Specialized Information Services, United States National Library of Medicine, National Institutes of Health, United States Department of Health & Human Services. [Accessed 2019 July 5]. Available from: https://chem.nlm.nih.gov/chemidplus/
- O'Neil MJ, Heckelman PE, Koch CB, Roman KJ, editors. 2009. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edition. 2006, 2009. Electronic version [online]. Whitehouse Station (NJ): Merck & Co., Inc. [Accessed 201 July 5]. Available at: http://www.medicinescomplete.com/#/
- Pray WS. 2006. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins.
- Repchinsky C, editor. 2002. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association.
- Sood N, Baker WL, Coleman CI. 2008. Effect of glucomannan on plasma lipid and glucose concentrations, body weight, and blood pressure: systematic review and meta-analysis. American Journal of Clinical Nutrition 88(4):1167-1175.
- Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press.
- USDA 2019: Germplasm Resources Information Network (GRIN), Amorphophallus konjac K. Koch. United States Department of Agriculture. [Accessed 2019 July 5]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
- Vanderbeek PB, Fasano C, O'Malley G, Hornstein J. 2007. Esophageal obstruction from a pharmacobezoar containing glucomannan. Clinical Toxicology 45(1):80-82.
- Vuksan V, Sievenpiper JL, Xu Z, Wong EYY, Jenkins AL, Beljan-Zdravkovic U, Leiter LA, Josse RG, Stavro M.P. 2001. Konjac-mannan and American ginsing: emerging alternative therapies for type 2 diabetes mellitus. Journal of the American College of Nutrition 20:370S- 380S.
- Walsh DE, Yaghoubian V, Behforooz A. 1984. Effect of glucomannan on obese patients: a clinical study. International Journal of Obesity 8(4):289-293.
References Reviewed
- Al-Ghazzewi FH, Khanna S, Tester RF, Piggott J. 2007. The potential use of hydrolysed konjac glucomannan as a prebiotic. Journal of the Science of Food and Agriculture 87:1758-1766.
- Alonso-Sande M, Teijeiro-Osorio D, Remuñán-López C, Alonso MJ. 2009. Glucomannan, a promising polysaccharide for biopharmaceutical purposes. European Journal of Pharmaceutics and Biopharmaceutics 72:453-462.
- Australian Competition and Consumer Commission. Commonwealth of Australia Gazette No. S 667, Monday 22 December 1986. Notice of Permanent Ban: Glucomannan in tablet form. Canberra (AU): Australian Government Publishing Service. [Accessed 2009-05-26]. Available from: www.accc.gov.au/content/index.phtml/itemId/780157
- Birketvedt GS, Shimshi M, Thom E, Florholmen J. 2005. Experiences with three different fiber supplements in weight reduction. Medical Science Monitor 11(1):15-18.
- Chen HL, Fan YH, Chen ME, Chan Y. 2005. Unhydrolyzed and hydrolyzed konjac glucomannans modulated cecal and fecal microflora in Balb/c mice. Nutrition 21:1059-1064.
- EC-SCF 1997: European Commission 1997 Reports of the Scientific Committee for Food (forty- first series): Opinion on the safety in use of konjac glucomannan as a food additive. Brussels (LU): Office for Official Publications of the European Communities [Accessed 2009-12-23]. Available from: http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_41.pdf
- EC-SCF 1997: European Commission 1997. Reports of the Scientific Committee for Food (forty-first series): Opinion on the safety in use of konjac gum as a food additive. Brussels (LU): Office for Official Publications of the European Communities [Accessed 2009-12-23]. Available from: http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_41.pdf
- EMA 2013. European Medicines Agency. Final Community Herbal Monograph on Plantago afra L. et Plantago indica L., semen. London (UK): EMA Committee on Herbal Medicinal Products (HMPC), 14 May 2013. [Accessed 2019 July 5]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-plantago-afra-l-et-plantago-indica-l-semen_en.pdf
- Facciola S. 1998. Cornucopia II: A Source Book of Edible Plants. Vista CA: Kampong Publications.
- FDA 1994: United States Food and Drug Administration. 1994. Dietary Supplement Health and Education Act of 1994. [Accessed 2009-12-24]. Available from: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCA ct/SignificantAmendmentstotheFDCAct/ucm148003.htm
- FDA 1993: United States Food and Drug Administration. 1993. 21 CFR Part 201. Warning Statements Required for Over-the-Counter Drugs Containing Water-soluble Gums as Active Ingredients. Final Rule. Federal Register Volume 58, No. 164, August 26, 1993. [Accessed 2009-12-29]. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Ov er-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm085690.pdf
- HC 2010: Health Canada. 2010. Licensed Natural Health Products Database. [Accessed 2010- 01-07]. Available from: http://webprod.hc-sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?language- langage=english
- HC 2010: Health Canada. 2010. Drug Product Database. [Accessed 2010-01-07]. Available from: http://webprod.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp
- HC 2009: Health Canada. 2009. Canada Vigilance Search REF: 09-137593-955 - Glucomannan.
- HC 1999. Health Canada. 1999. Listing of drugs currently regulated as new drugs. [Accessed 2008-04-11]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic- demande/guide-ld/newdrug-drognouv/index_e.html.
- JC 2009: Justice Canada 2009. Food and Drugs Act. [Accessed 2009-10-28]. Available from: http://laws.justice.gc.ca/en/F-27/index.html
- Livieri C, Novazi F, Lorini R. 1992. The use of highly purified glucomannan-based fibers in childhood obesity. La Pediatria medica e chirurgica 14(2):195-198.
- Natural Health Products Directorate. 2009. Natural Health Products Ingredients Database. [Accessed 2009-06-22]. Available from: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search- rechercheReq.do
- Roberts A, O'Brien M, Subak-Sharpe G. 2001. Glucomannan, The Official American Nutraceutical Association Guide, Nutraceuticals The Complete Encyclopedia of Supplements, Herbs, Vitamins, and Healing Foods.
- Saper RB, Eisenberg DM, Phillips RS. 2004. Common dietary supplements for weight loss. American Family Physician 70(9):1731-178.
- Vasques CAR, Rossetto S, Halmenschlager G, Linden R, Heckler E, Fernandez MSP, Alonso JLL. 2008. Evaluation of the pharmacotherapeutic efficacy of Garcia cambogia plus Amorphophallus konjac for the treatment of obesity. Phototherapy Research 22:1135-1140.
- Villaverde AF, Benlloch S, Berenguer M, Rayon JM, Pina R, Berenguer J. 2004. Acute hepatitis of cholestatic type possibly associated with the use of glucomannan (Amorphophallus konjac). Journal of Hepatology 41:1061-1067.
- Vuksan V, Sievenpiper JL, Owen R, Swilley JA, Spadafora P, Jenkins FJA, Vidgen E, Brighenti F, Josse RG, Leiter LA, Xu Z, Novokmet R. 2000. Beneficial effects of viscous dietary fibre from konjac-mannan in subjects with the insulin resistance syndrome. Diabetes Care 23:9-14.
- Vuksan V, Jenkins DJA, Spadafora P, Sievenpiper JL, Owen R, Vidgen E, Brighenti F, Josse R, Leiter LA, Thompson CB. 1999. Konjac-mannan (glucomannan) improves glycemia and other associated risk factors for coronary heart disease in type 2 diabetes. Diabetes Care 22:913-919.
- Yoshida M, Vanstone CA, Parsons WD, Zawistowski J, Jones PJ. 2006. Effect of plant sterols and glucomannan on lipids in individuals with and without type II diabetes. European Journal of Clinical Nutrition 60(4):529-537.