Mendis 2001

Methods	RCT, 2 arm, parallel (n‐6 LA vs non‐fat), 1 year Summary risk of bias: moderate to high
Participants	Healthy volunteers responding to survey. Some had hyperlipidaemia. CVD risk: low N: 30 intervention, 30 control (analysed 26 intervention, 28 control) % male: 78% (total) Mean age: not reported Age range: 20‐65 years 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 *Lipid lowering medications as well as many others were not allowed. Location: Sri Lanka Ethnicity: 100% Sri Lanakan
Interventions	Type: diet advice plus test fat supplement Comparison: n‐6 vs non‐fat (unclear if CHO, protein or both) Intervention: group B received a diet containing 20% E as fat (4.7% coconut fat) plus 7.5 g/day test fat containing soybean fat‐sesame fat (3:1, v/v containing PUFA:MUFA ratio 2). Fat intake in group B was, therefore, 24% E (test fat provided additional 5 g/d PUFA mainly LA) Control: group A received a diet containing 20% E as fat (4.7% E coconut fat) Dose aim: increase 5 g/d PUFA or 45 kcal or 2.2% E PUFA, assume˜2% E LA Baseline n‐6: unclear Compliance by biomarkers: poor, serum total cholesterol was not significantly reduced in intervention compared to control (0.16 mmol/L, 95% CI −0.18 to 0.50). The intervention group were stated as having higher dietary PUFA:SFA ratio than controls, but no blood levels of FAs were reported. Compliance by dietary intake: unclear, measured by field workers' visits and using food diaries Energy intake: intervention 7962 kJ/d (SD 1568), control 8030 kJ/d (SD 1465) Total fat intake: intervention 24% E (SD not reported), control 20% E (SD not reported) Saturated fat intake: intervention 11.4% E (SD not reported), control 11.8% E (SD not reported) PUFA intake: not reported (unsaturated fat intake intervention 12.6% E, control 8.2% E, test fat reported as mainly LA) PUFA n‐3 intake: not reported PUFA n‐6 intake: (unsaturated fat intake intervention 12.6% E, control 8.2% E, test fat reported as mainly LA) Trans fat intake: not reported MUFA intake: not reported CHO intake, % E: intervention 64 (SD not reported), control 67 (SD not reported) Sugars intake: not reported Protein intake: intervention 12.2% E (SD not reported), control 12.1% E (SD not reported) Alcohol intake: not reported Duration of intervention: 1 year
Outcomes	Main study outcome: serum lipids Dropouts: intervention 4, control 2 Available outcomes: lipids
Notes	Study funding: National Science Foundation of Sri Lanka Response to contact: no response to attempted contact
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participants were randomised to 2 groups (groups A and B). This was done in such a way that the 38 hyperlipidaemic subjects were equally divided between the 2 groups
Allocation concealment (selection bias)	Unclear risk	No details
Blinding of participants and personnel (performance bias) All outcomes	High risk	The groups had different diets with test fat added to intervention group
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details
Incomplete outcome data (attrition bias) All outcomes	High risk	6 participants dropped out at 6 months but their data is not included in the analysis at all
Selective reporting (reporting bias)	Unclear risk	No protocol or trial register entry found
Attention Bias	Low risk	Both groups had twice weekly visits by field workers
Compliance	High risk	Compliance poor when assessed by biomarkers
Other bias	Unclear risk	No details provided on the form or method of supply of diet or test fat