title: Risk assessment for carnitine.
abstract: Carnitine is a conditionally essential amino acid-like compound involved in the transport of long-chain fatty acids into the mitochondria during the beta-oxidation process. Carnitine has become an increasingly popular ingredient in dietary supplements, especially weight loss and some sports nutrition products. A number of clinical trials have been conducted examining the effect of carnitine supplementation on weight loss and energy balance. Regarding safety, systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 2000mg/day l-carnitine equivalents for chronic supplementation, and this level is identified as the OSL. Although much higher levels have been tested without adverse effects and may be safe, the data for intakes above 2000mg/day are not sufficient for a confident conclusion of long-term safety.
authors.affiliation: Council for Responsible Nutrition, 1828 L St., NW, Suite 900, Washington, DC 20036-5114, USA. jhathcock@crnusa.org
authors.forename: John N
authors.initials: JN
authors.lastname: Hathcock
authors.forename: Andrew
authors.initials: A
authors.lastname: Shao
mesh_terms: D002331:Carnitine / Q000009:adverse effects*; D019587:Dietary Supplements / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods
chemical_list: D002331:Carnitine