Methods	RCT
Participants	Healthy postmenopausal women with above median serum testosterone (Italy) CVD risk: low Control: randomised 57, analysed at 6 months 55 Intervention: randomised 58, analysed at 6 months 51 Mean years in trial: control 4.38, intervention 4.28 % male: 0 Age: mean unclear (age range 48-69)
Interventions	Reduced and modified fat vs usual diet Control aims: advised to increase fruit and vegetable intake Intervention aims: taught Sicilian diet including reduced total, saturated and omega–6 fats, increased blue fish (high in omega 3), increased whole cereals, legumes, seeds, fruit and vegetables Control methods: advice Intervention methods: taught Sicilian diet and cooking by professional chefs, with a weekly cooking course including social dinners Total fat intake (at 6 months): low & mod fat 30.9 (sd 11.4), cont 34.0 (sd 11.8)%E Saturated fat intake (at 6 months): low & mod fat 8.4 (sd 3.0), cont 11.2 (sd 5.0)%E Style: diet advice Setting: community
Outcomes	Stated trial outcomes: breast cancer, weight, lipids, wellbeing Data available on total mortality? yes (no events) Cardiovascular mortality? yes (no events) Events available for combined cardiovascular events: cardiovascular deaths, non fatal MI, stroke, ventricular fibrillation, ventricular overload Secondary outcomes: total and non-fatal MI, stroke, cancer diagnoses and deaths (events only for stroke and cancer diagnoses) Tertiary outcomes: none
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“individually randomised”
Allocation concealment (selection bias)	Unclear risk	Randomisation method not clearly described
Blinding (performance bias and detection bias) All outcomes	High risk	Participants were aware of assignment, researchers unclear
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear, deaths, cancer and CV events are drop-outs, trialists asked for data - unclear if any data missing
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists asked for data
Other bias	Low risk
Free of systematic difference in care?	High risk	Intensive cookery course with social element compared with briefadvice. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies
Free of dietary differences other than fat?	High risk	Both groups encouraged to increase fruit and vegetables, but intervention group also encouraged to increase fish, pulses, seeds, whole grains