Inulin
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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
October 29, 2021Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | Source information | Preparation(s) | |
---|---|---|---|---|
Source material(s) | Part(s) | |||
Inulin |
Inulin |
Cichorium intybus |
Root |
Isolate |
Helianthus tuberosus |
Tuber |
References: Proper name: CFIA 2016, IOM 2005; Common name: CFIA 2016, IOM 2005; Source information: USDA 2019a,b, CFIA 2016, IOM 2005, McGuffin et al. 2000.
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.
Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.
Use(s) or Purpose(s)
- Source of fiber for the maintenance of good health (CFIA 2016; FCC 8 2012; IOM 2005).
- Helps support and maintain a healthy digestive system (CFIA 2016; FCC 8 2012; IOM 2005).
- Helps stimulate the growth of healthy bacteria (such as bifidobateria) in the intestine/gut (Marteau et al. 2011; Roberfroid 2007a; Menne et al. 2000; Gibson et al. 1995).
- Prebiotic (Marteau et al. 2011; Roberfroid 2007a,b; Menne et al. 2000; Gibson et al. 1995).
- Helps provide gentle relief of constipation and/or irregularity (Marteau et al. 2011; IOM 2005; Kleessen et al. 1997).
The following combined use(s) or purpose(s) is/are also acceptable:
Prebiotic which helps stimulate the growth of healthy bacteria (such as bifidobacteria) in the intestine/gut (Marteau et al. 2011; Roberfroid 2007a,b; Menne et al. 2000; Gibson et al. 1995).
Dose(s)
Subpopulation(s)
Adults 18 years and olderQuantity(ies)
Source of fiber, healthy digestive system, constipation/irregularity2-15 grams of Inulin, per day (Kolida and Gibson 2007; IOM 2005; Menne et al. 2000; Coussement 1999).
Prebiotic, healthy bacteria5-15 grams of Inulin, per day (Kolida and Gibson 2007; Menne et al. 2000; Coussement 1999).
Direction(s) for use
Products providing 5 g or more of Inulin, per dose
Powder- Mix well with at least 240 milliliters of liquid (e.g. water, milk, fruit juice or similar aqueous beverage). Stir briskly and drink immediately (Pray 2006).
- Take 2 hours before or after taking other medications or natural health products (Pray 2006).
- Optional: Take during the day (not immediately prior to bedtime) (Sweetman 2007).
- Take with at least 240 milliliters of liquid (e.g. water, milk, fruit juice or similar aqueous beverage)(Pray 2006).
- Take 2 hours before or after taking other medications or natural health products (Pray 2006).
- Optional: Take during the day (not immediately prior to bedtime) (Sweetman 2007).
Duration(s) of use
No statement required.Risk information
Caution(s) and warning(s)
Products for constipation/irregularity- 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).
- 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).
- 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 diabetes (Pray 2006).
Contraindication(s)
No statement required.Known adverse reaction(s)
All productsStop use if hypersensitivity/allergy occurs (Brinker 2010; Hendler and Rorvik 2008; Franck et al. 2005; Gay-Crosier et al. 2000).
Products providing 5 g or more of Inulin, per dayMay cause temporary gas and/or bloating (Marteau et al. 2011; Kolida and Gibson 2007; Menne et al. 2000; Coussement 1999; Klessen et al. 1997).
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
Store in a well-closed container at room temperature (USP 35 2012).
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
- Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
- CFIA 2016: Canadian Food Inspection Agency, Food Labelling for Industry, Chapter 6: Elements Within the Nutrition Facts Table Section 6.8.1 Dietary Fibre. [Accessed 2019 June 26]. Available from: http://www.inspection.gc.ca/food/requirements-and-guidance/labelling/industry/eng/1383607266489/1383607344939
- Coussement PAA 1999. Inulin and Oligofructose: safe intakes and legal status. The Journal of Nutrition 1999;129:1412S-1417S.
- FCC 8: Food Chemicals Codex. Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
- Franck P, Moneret-Vautrin DA, Morisset M, Kanny G, Mégret-Gabeaux ML, Olivier JL. Anaphylactic reaction to inulin : first identification of specific IgEs to an inulin protein compound. International Archives of Allergy and Immunology 2005;136:155-158.
- Gay-Crosier F, Schreiber G, Huaser C. Anaphylaxis from inulin in vegetables and processed food. The New England Journal of Medicine 2000;342(18):1372.
- Gibson GR, Beatty ER, Wang X, Cummings JH. Selective stimulation of bifidobacteria in the human colon by oligofructose and inulin. Gastroenterology 1995;108(4):975-82.
- Hendler SS, Rorvik DM, editors. Physician Desk References (PDR) for Nutritional Supplements, 2nd edition. Montvale (NJ): Thomson Reuters, 2008.
- IOM 2005: Institute of Medicine of the National Academies. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board. [Accessed 2019 June 26]. Available from: https://www.nap.edu/read/10490/chapter/12#680
- Kleessen B, Sykura B, Zunft H-J, Blaut M. Effects of inulin and lactose on fecal microflora, microbial activity, and bowel habit in elderly constipated persons. American Journal of Clinical Nutrition 1997;65(5):1397-1402.
- Kolida S, Gibson GR. 2007. Prebiotic capacity of inulin-type fructans. The Journal of Nutrition 2007;137:2503S-2506S.
- Marteau P, Jacobs H, Cazaubiel M, Signoret C, Prevel J-M, Housez B. Effects of chicory inulin in constipated elderly people: a double-blind controlled trial. International of Food Sciences and Nutrition 2011;62(2):164-170.
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- Menne E, Guggenbuhl, Roberfroid M. Fn-type chicory inulin hydrolysate has a prebiotic effect in humans. Journal of Nutrition 2000;130:1197-1199.
- Pray WS. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
- Ramnani P, Gaudier E, Bingham M, van Bruggen P, Tuohy KM, Gibson GR. Prebiotic effect of fruit and vegetable shots containing Jerusalem artichoke inulin: a human intervention study. British Journal of Nutrition 2010;104(2):233-240.
- Roberfroid MB. Inulin-type fructans: functional food ingredients. The Journal of Nutrition 2007a;137:2493S-2502S.
- Roberfroid M. Prebiotics: The Concept Revisited. The Journal of Nutrition 2007b;137:830S-837S.
- USDA 2019a: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Cichorium intybus L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 June 26]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
- USDA 2019b: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Helianthus tuberosus L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 June 26]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
- USP 35: United States Pharmacopeia and the National Formulary (USP 35 - NF 30). Rockville (MD): The United States Pharmacopeial Convention; 2012.
References reviewed
- BHC 1992: Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs—Companion to Volume 1 of the British Herbal Pharmaocopeia. Bournemouth (GB): British Herbal Medicine Association; 1992.
- Brighenti F, Casiraghi MC, Canzi E, Ferrari A. Effect of consumption of a ready-to-eat breakfast cereal containing inulin on the intestinal milieu and blood lipids in healthy male volunteers. European Journal of Clinical Nutrition 1999;53(9):726-33.
- Causey JL, Feirtag JM, Gallaher DD, Tungland BC, Slavin JL. Effects of dietary inulin on serum lipids, blood glucose and the gastrointestinal environment in hypercholesterolemic men. Nutrition Research 2000;20:191-201.
- Den Hond E, Geypens B, Ghoos Y. Effect of high performance chicory inulin on constipation. Nutrition Research 2000;20(5):731-736.
- ESCOP 2003: E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products. 2nd edition. Exeter (GB): ESCOP, the European Scientific Cooperative on Phytotherapy in collaboration with Georg Thieme Verlag and Thieme; 2003.
- Kim SH, Lee DH, Meyer D, Supplementation of infant formula with native inulin has a prebiotic effect in formula-fed babies. Asia Pacific Journal of Clinical Nutrition 2007;16(1):172-177.
- Pourghassem GB, Dehghan P, Aliasgharzadeh A, Asghari J-AM. Effects of high performance inulin supplementation on glycemic control and antioxidant status in women with type 2 diabetes. Diabetes Metabolism Journal 2013;37(2):140-148.
- Rao AV. Dose-Response effects of inulin and oligofructose on intestinal bifidogenesis effects. Journal of Nutrition 1999;129:1442S-1445S.
- Roberfroid MB, Van Loo JAE, Gibson GR. The bifidogenic nature of chicory inulin and its hydrolysis products journal of nutrition 1998;128:11-19.
- Szajewska H, Wizman Z, Abu-Zekry M, Kekez A, Braegger C, Kolacek S, Micetic-Turk D, Ruszczynski M, Vukavic T. Inulin and fructo-oligosaccharides for the prevention of antibiotic-associated diarrhea in children: report by the ESPHGAN working group on probiotics and prebiotics. Journal of Pediatric Gastroenterology and Nutrition 2012;54(6):828-829.
- Van Dokkum W, Wezendonk B, Srikumar TS, van den Heuvel EGHM. Effect of nondigestible oligosaccharides on large-bowel functions, blood lipid concentrations and glucose absorption in young healthy male subjects. European Journal of Clinical Nutrition 1999;53(1):1-7.
- Yap WKW, Mohamed S, Jamal MH, Meyer D, Manap YA. Changes in infant faecal characteristics and microbiota by inulin supplementation. Journal of Clinical Biochemistry Nutrition 2008;43:159-166.
- WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.