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Drugs and Health Products

Monograph: Chlorella - Chlorella Vulgaris

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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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

November 18, 2014

Proper Name(s)

Chlorella vulgaris Beyerinck (Guiry and Guiry 2014)
Synonym: Chlorella pyrenoidosa Chick (Guiry and Guiry 2014; Misurcova et al. 2014)

Common Name(s)

Chlorella (Lee et al. 2010; Tiberg et al. 1995)

Source Material(s)

Broken cell (Becker 2007)

Route(s) of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules,chewables (e.g. tablets), liquids, powders, strips or tablets
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of
All products
Source of/Provides antioxidants (Lee et al. 2010).
Uses based on constituent potency, provided at or above the minimum doses indicated in the dose section below:
Constituents: Vitamins and Minerals
  • Source of vitamins and/or minerals for the maintenance of good health.
  • Ingredient-specific uses or purposes as per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.
Constituents: Proteins/Essential amino acids/Non-essential amino acids
  • Source of protein for the maintenance of good health (IOM 2005; Lubitz 1963).
  • Source of protein which helps build and repair body tissues (IOM 2005; Lubitz 1963)
  • Source of (an) (essential) amino acid(s) involved in muscle protein synthesis (Misurcova 2014; IOM 2002).
  • Source of (an) essential amino acid(s) for the maintenance of good health (Misurcova 2014; IOM 2002).

Dose

Sub population

Adults (≥ 18 years)

Quantities

Dry, Powder, Non-standardized ethanolic extracts (fluid extract, tincture), decoction
Up to 6 g per day (Lee et al. 2010).
Constituents: Vitamins and Minerals
As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph
Constituents: Proteins/Essential amino acids/Non-essential amino acids
As per the NNHPD Workout Supplement Monograph
Notes
  • For a use or purpose based on a particular constituent (e.g. beta-carotene, iron, protein), the name and the amount of the constituent must be provided in the potency section of the Product License Application form.
  • The minimum and maximum daily doses of the constituent must be within the range of the doses listed on the NNHPD Multi-Vitamin/Mineral Supplements Monograph or the NNHPD Workout Supplements Monograph.
  • If ingredients such as vitamins and minerals are added to the product they should be listed as separate medicinal ingredients on the Product Licence Application form and label. In this case, it would be considered a Class II or III application.

Direction of Use

Statement(s) to the effect of
Products providing ≥ 250 mg chlorella per day
Take a few hours before or after taking other medications or natural health products (Sweetman 2007; ASHP 2005).

Duration of Use

No statement required

Risk Information

Statement(s) to the effect of

Caution(s) and Warning(s)

All products
If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
Products providing ≥ 250 mg chlorella per day or ≥ 6 μg vitamin K per day
If you are taking blood thinners, consult a health care practitioner prior to use (Ohkawa et al. 1995; Current NNHPD Multi-Vitamin/Mineral Supplements monograph).
Products providing chlorella enriched with selenium
If you have a history of non-melanoma skin cancer, consult a health care practitioner prior to use (Doucha et al. 2009; Current NNHPD Selenium monograph).

Contraindication(s)

No statement required

Known Adverse Reaction(s)

Hypersensitivity/allergy can occur, in which case discontinue use and consult your healthcare practitioner (Tiberg et al. 1995).

Storage Condition(s)

No statement required

Non Medicinal Ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide..
  • The raw material tolerance limit for microcystins is 1 ppm. Note that Health Canada has published an article comparing various methods available to determine microcystin concentration levels (Gilroy 2001; Lawrence et al. 2001).
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID).

References Cited

ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.

Becker EW. Micro-algae as a source of protein. Biotechnology Advances 2007;25:207-210.

Doucha J, Livansky K, Kotrbacek V, Zachleder V. Production of Chlorella biomass enriched by selenium and its use in animal nutrition: a review. Applied Microbiology and Biotechnology2009;83(6):1001-8.

Guiry, MD, Guiry GM. AlgaeBase. 2014. Next link will take you to another Web site . World-wide electronic publication, National University of Ireland, Galway. Algaebase taxon LSID: urn:lsid:algaebase.org:taxname:47342 [Accessed 2014 January 21].

IOM 2005: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board, Institute of Medicine. Washington (DC): National Academy Press; 2005.

IOM 2002: 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, Institute of Medicine. Washington (DC): National Academy Press; 2002.

Lee SH, Kang HJ, Lee HJ, Kang MH, Park YK. Six-week supplementation with Chlorella has favorable impact on antioxidant status in Korean male smokers. Nutrition 2010;26(2):175-83.

Lubitz JA. The Protein Quality, Digestibility, and Composition of Algae, Chlorella 71105. Journal of Food Science 1963;28(2):229-232.

Misurcova L, Bunka F, Vavra Ambrozova J, Machu L, Samek D, Kracmar S. Amino acid composition of algal products and its contribution to RDI. Food Chemistry 2014;151:120-125.

Ohkawa S, Yoneda Y, Ohsumi Y, Tabuchi M. Warfarin therapy and chlorella. Rinsho Shinkeigaku 1995;35(7):806-807.

Sweetman SC, editor. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press; 2007.

Tiberg E, Dreborg S, Bjorksten B. Allergy to green algae (Chlorella) among children. Journal of Allergy and Clinical Immunology 1995;96(2):257-259.

References Reviewed

Halperin SA, Smith B, Nolan C, Shay J, Kralovec J. Safety and immunoenhancing effect of a Chlorella-derived dietary supplement in healthy adults undergoing influenza vaccination: randomized, double-blind, placebo-controlled trial. Canadian Medical Association Journal 2003;169(2):111-7.

Mandalam RK, Palsson BO. Elemental balancing of biomass and medium composition enhances growth capacity in high-density Chlorella vulgaris cultures. Biotechnology Bioengineering 1998;59(5):605-611.

Merchant RE, Andre CA, Sica DA. Nutritional Supplementation with Chlorella pyrenoidosa for Mild to Moderate Hypertension. Journal of Medicinal Food. September 2002;5(3):141-152.

Merchant RE, Andre CA. A review of recent clinical trials of the nutritional supplement Chlorella pyrenoidosa in the treatment of fibromyalgia, hypertension, and ulcerative colitis. Alternative Therapies in Health and Medicine 2001;7(3):79-91.

Merchant RE, Carmack CA, Wise CM. Nutritional supplementation with Chlorella pyrenoidosa for patients with fibromyalgia syndrome: a pilot study. Phytotherapy Research 2000;14(3):167-73.

Nakano S, Noguchi T, Takekoshi H, Suzuki G, Nakano M. Maternal-fetal distribution and transfer of dioxins in pregnant women in Japan, and attempts to reduce maternal transfer with Chlorella (Chlorella pyrenoidosa) supplements. Chemosphere 2005;61(9):1244-1255.