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Clinical safety evaluation of marine oil derived from Calanus finmarchicus
Institution:1. Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA;2. Department of Medicine, University of North Carolina, Chapel Hill, NC, USA;3. Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA
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.
Keywords:Calanus oil  Clinical trial  Safety  ALP"}  {"#name":"keyword"  "$":{"id":"kwrd0030"}  "$$":[{"#name":"text"  "_":"alkaline phosphatase  ALT"}  {"#name":"keyword"  "$":{"id":"kwrd0040"}  "$$":[{"#name":"text"  "_":"alanine aminotransferase  APO"}  {"#name":"keyword"  "$":{"id":"kwrd0050"}  "$$":[{"#name":"text"  "_":"apolipoprotein  AST"}  {"#name":"keyword"  "$":{"id":"kwrd0060"}  "$$":[{"#name":"text"  "_":"aspartate aminotransferase  BMI"}  {"#name":"keyword"  "$":{"id":"kwrd0070"}  "$$":[{"#name":"text"  "_":"body mass index  DHA"}  {"#name":"keyword"  "$":{"id":"kwrd0080"}  "$$":[{"#name":"text"  "_":"docosahexaenoic acid  EFSA"}  {"#name":"keyword"  "$":{"id":"kwrd0090"}  "$$":[{"#name":"text"  "_":"European Food Safety Authority  EPA"}  {"#name":"keyword"  "$":{"id":"kwrd0100"}  "$$":[{"#name":"text"  "_":"eicosapentaenoic acid  ESR"}  {"#name":"keyword"  "$":{"id":"kwrd0110"}  "$$":[{"#name":"text"  "_":"erythrocyte sedimentation rate  GGT"}  {"#name":"keyword"  "$":{"id":"kwrd0120"}  "$$":[{"#name":"text"  "_":"γ-glutamyl transferase  HACCP"}  {"#name":"keyword"  "$":{"id":"kwrd0130"}  "$$":[{"#name":"text"  "_":"hazard analysis and critical control point  HbA1c"}  {"#name":"keyword"  "$":{"id":"kwrd0140"}  "$$":[{"#name":"text"  "_":"hemoglobin A1c  HDL"}  {"#name":"keyword"  "$":{"id":"kwrd0150"}  "$$":[{"#name":"text"  "_":"high-density lipoprotein  HS-CRP"}  {"#name":"keyword"  "$":{"id":"kwrd0160"}  "$$":[{"#name":"text"  "_":"high sensitivity C-reactive protein  PTH"}  {"#name":"keyword"  "$":{"id":"kwrd0170"}  "$$":[{"#name":"text"  "_":"parathyroid hormone  PUFAs"}  {"#name":"keyword"  "$":{"id":"kwrd0180"}  "$$":[{"#name":"text"  "_":"polyunsaturated fatty acids  T4"}  {"#name":"keyword"  "$":{"id":"kwrd0190"}  "$$":[{"#name":"text"  "_":"free thyroxine  TSH"}  {"#name":"keyword"  "$":{"id":"kwrd0200"}  "$$":[{"#name":"text"  "_":"thyroid stimulating hormone  WH"}  {"#name":"keyword"  "$":{"id":"kwrd0210"}  "$$":[{"#name":"text"  "_":"waist-hip
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