Dodin 2005

Methods	RCT, parallel, (n‐3 ALA vs n‐6 LA), 12 months Summary risk of bias: moderate or high
Participants	Healthy menopausal women N: 101 intervention, 98 control. (analysed, intervention: 85 control: 94) Level of risk for CVD: low Men: 0% intervention, 0% control Mean age in years (SD): 54.0 (4.0) intervention, 55.4 (4.5) control Age range: 49‐65 Smokers: 8% intervention, 6% control 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: Canada Ethnicity: French Canadian
Interventions	Type: food supplement (flaxseed) Comparison: ALA vs unclear (probably includes lipids, CHO and protein, but not clear) Intervention: 40 g/d flaxseed incorporated into diets (providing 21,071 g total lignans, 180 calories, 16 g lipids (57% ALA), and 11 g total dietary fibre). Dose: 9.1 g/d ALA Control: 40 g/d wheat germ incorporated into diets (providing 196 g total lignans, 144 calories, 4 g lipids (6.9% ALA), and 6 g total dietary fibre Compliance: first morning urine collection was performed at randomisation and at month 12 to measure urinary lignin levels. In addition, study participants recorded their daily intake of seeds on diary cards and were asked to return unused bread and packages of seeds at each visit. Good compliance reported Duration of intervention: 12 months
Outcomes	Main study outcome: bone mineral density Dropouts: 26 intervention, 17 control (but 13/17 had an endpoint evaluation) Available outcomes: weight, BMI, QoL, blood pressure, lipids, glucose, adverse events, dietary intake, plasma fatty acids Response to contact: yes
Notes	Auhors replied to tell us that there were no deaths or CV events during the study Study funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation schedule was prepared by the clinical unit of the research centre using computer generated randomisation in blocks of 4‐8
Allocation concealment (selection bias)	Unclear risk	No details
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants, investigators, staff, and statisticians were blinded to dietary assignments for the duration of the study. Quote: "a local baker prepared loaves of bread. Each week, the loaves of bread were delivered in sealed, opaque unmarked wrappers to the Department of Food and Nutrition Sciences at Laval University. The seeds were ground up and vacuum‐packed in the same laboratory. The Department of Food and Nutrition Sciences was responsible for labelling the bags of bread and packages of seeds with the subject's randomization number. Bread and packages of seeds were provided on a 3‐month basis. The foods that both groups received was similar in appearance and packaging and was kept frozen until consumption to avoid essential fatty acid
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Participants, investigators, staff, and statisticians were blinded to dietary assignments for the duration of the study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat analysis. Loss to follow‐up 10%, reasons given
Selective reporting (reporting bias)	Unclear risk	No protocol or clinical trial registry entry found
Attention	Low risk	All participants had same number of visits
Compliance	Low risk	First morning urine collection was performed at randomisation and at month 12 to measure urinary lignin levels. In addition, study participants recorded their daily intake of seeds on diary cards and were asked to return unused bread and packages of seeds at each visit. Good compliance reported
Other bias	Low risk	None noted