Tande 2016

Methods	2 arm, parallel RCT (calanus (marine) oil vs olive oil), 12 months Summary risk of bias: moderate to high
Participants	Healthy male and female volunteers with BMI 25‐35 kg/m2 N: 64 intervention, 63 control (50 intervention, 50 control analysed) Level of risk for CVD: low Men: 42% intervention, 43 % control Mean age in years (SD): 50.7 (7.7) intervention, 49 (9.4) control Age range: unclear (18 years and older) Smokers: not reported Hypertension: not reported Medications taken by at least 50% of those in the control group: not reported Medications taken by 20%‐49% of those in the control group: not reported Medications taken by some, but less than 20% of the control group: not reported Location: Norway Ethnicity: not reported
Interventions	Type: supplement (capsule) Comparison: EPA + DHA vs MUFA Intervention: 2 × 500 mg Calanus oil capsules twice daily to provide a daily dose of 2 g. Supplements were provided by Ayanda AS (Norway) as blister packs of 60 capsules each. The Calanus oil contained approximately 85% wax ester with a sum of neutral lipids > 90%. Dose: 2 g/d EPA + DHA Control: identical capsules of olive oil. Compositional analysis indicated that the fatty acid content of the olive oil was primarily oleic acid (76.9%), palmitic acid (10.2%), and linoleic acid (7.7%). Compliance: assessed through the return of unused capsules. Compliance rate reported for both intervention and placebo groups was good (86‐88%) Length of intervention: 12 months
Outcomes	Main study outcome: safety of Calanus oil consumption Dropouts: 14 intervention, 13 control Available outcomes: BMI, waist‐hip ratio, BP, pulse, HbA1c, ESR, CRP, lipids, glucose tolerance, insulin, clinical chemistry parameters, adverse events (no CVD events, deaths or other major health outcomes occurred according to author reply) Response to contact: author replied with methodological and event information
Notes	Study funding: Calanus AS
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization of the study subjects into the intervention group or the placebo group was performed by the University Hospital of North Norway clinical research unit and was stratified by gender." Author reply stated that "[r]andomization was performed by competent people at the drugstore affiliated to the University Hospital, with no interconnection, formally or materially with the research department from where the study was managed. Randomization was performed prior to recruiting subjects."
Allocation concealment (selection bias)	Unclear risk	As above, unclear.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants in the placebo group received identical capsules at similar daily doses as the intervention group. However, no information provided as to their smell and taste. Also unclear if investigators were blinded. Author reply stated "Each study subject was given a randomization number, which carried the name of the person, date of birth and treatment information (intervention or control). The randomization number was the only information made available to the study personnel, and the code was managed by personnel outside the research department. This code was broken after the completion of all analysis with all primary data processed." Blinding of participants only possible for fish plus supplementation vs fish plus placebo.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	As above
Incomplete outcome data (attrition bias) All outcomes	Low risk	All dropouts (˜20%) are explained
Selective reporting (reporting bias)	Unclear risk	No trials registry entry or protocol found
Attention	Low risk	Appear to be similar in both groups
Compliance	Unclear risk	Quote: "levels of DHA and EPA in the blood were generally higher in the Calanus oil group over baseline values relative to the placebo controls" but no data provided
Other bias	Low risk	None noted