CONJUGATED LINOLEIC ACID

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Monograph: CONJUGATED LINOLEIC ACID (English) (PDF Version - 36 K)

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

July 31, 2018

Background

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Common(s) name(s) Preparation(s)
Conjugated linoleic acid
  • Conjugated linoleic acid
  • CLA
    		•  Conjugated linoleic acid Synthetic

    References: Proper name: Pariza 2004, Pariza et al. 2001; Common names: Pariza 2004, Pariza et al. 2001; Source material: FDA 2007, Pariza et al. 2001.

    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 form for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

    Use(s) or Purpose(s)

    The following combined use(s) or purpose(s) is/are also acceptable

    Dose(s)

    Subpopulation(s)

    Adults 18 years and older

    Quantity(ies)

    3-5 grams of CLA, per day (Raff et al. 2009; Gaullier et al. 2007; Watras et al. 2007; Pinkoski et al. 2006; Gaullier et al. 2004; Kamphuis et al. 2003).

    Notes
    Additional information not to be submitted with the compendial PLA (although the quantity of CLA-rich oil may be requested at the NNHPD's discretion): Approximately 4-6.5 g CLA-rich oil provides 3-5 g CLA.

    Direction(s) for use

    Optional: Take with food (Watras et al. 2007; Kamphuis et al. 2003).

    Duration(s) of use

    Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 6 months (Gaullier et al. 2007; Watras et al. 2007; Gaullier et al. 2005; Gaullier et al. 2004).

    Risk information

    Caution(s) and warning(s)

    Contraindication(s)

    Do not use this product if you have cardiovascular disease (CVD), diabetes, metabolic syndrome or insulin resistance (Tholstrup et al. 2008; Gaullier et al. 2007; Steck et al. 2007; Larsen et al. 2006; Taylor et al. 2006; Gaullier et al. 2005; Smedman et al. 2005; Gaullier et al. 2004; Moloney et al. 2004; Basu et al. 2000a; Basu et al. 2000b).

    Known adverse reaction(s)

    Some people may experience gastrointestinal upset (Gaullier et al. 2007; Pinkoski et al. 2006; Berven et al. 2000; Blankson et al. 2000).

    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

    No statement required.

    Specifications

    References cited

    References reviewed