title: Clinical safety evaluation of marine oil derived from Calanus finmarchicus.
abstract: Marine oils are rich in polyunsaturated fatty acids (PUFAs), including docosahexaenoic and eicosapentaenoic acid. These PUFAs are associated with health benefits and additional sustainable sources of marine oils are desirable. One of the source organisms is Calanus finmarchicus, a copepod endemic to the North Atlantic. PUFAs in the lipid fraction of this organism are largely in the form of wax esters. To assess the safety of these wax esters as a source of PUFAs, a randomized, double-blinded, placebo-controlled clinical trial was conducted whereby 64 subjects consumed 2 g Calanus oil in capsule form daily for a period of one year. A group of 53 subjects consumed placebo capsules. At baseline, 6-, and 12-months, series of evaluations were conducted, including: vital signs, clinical chemistry and hematological evaluations, and adverse event reporting. Food intake and physical exercise were controlled by means of a questionnaire. There were no effects on Calanus oil treatment on any of the safety parameters measured. A slight increase in the incidence of eczema was reported in the Calanus oil group, but the response was minor in nature, not statistically significant after controlling for multiple comparisons, and could not be attributed to treatment.
authors.affiliation: Calanus AS, Stakkevollveien 65, N-9010, Tromsø, Norway. Electronic address: kurt.tande@calanus.no.
authors.forename: Kurt S
authors.initials: KS
authors.lastname: Tande
authors.affiliation: Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario, L5N 2X7, Canada.
authors.forename: Trung D
authors.initials: TD
authors.lastname: Vo
authors.affiliation: Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario, L5N 2X7, Canada.
authors.forename: Barry S
authors.initials: BS
authors.lastname: Lynch
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000818:Animals; D002214:Capsules; D033342:Copepoda / Q000737:chemistry*; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D004952:Esters / Q000008:administration & dosage / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D005231:Fatty Acids, Unsaturated / Q000008:administration & dosage / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D008297:Male; D008875:Middle Aged; D009664:Norway; D061214:Patient Safety; D018570:Risk Assessment; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014885:Waxes / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D002214:Capsules; D004952:Esters; D005231:Fatty Acids, Unsaturated; D014885:Waxes
keywords: Calanus oil; Clinical trial; Safety