Vincent‐Baudry 2005.

Methods	RCT of parallel‐group design
Participants	Medi‐RIVAGE study conducted in France. Participants recruited from Center for Detection and Prevention of Arteriosclerosis at La Timone University Hospital. 232 were invited and 212 were randomised. Inclusion criteria: at least 1 of the following criteria: fasting plasma cholesterol concentration of 6.5 to 7.7 mmol/L; triacylglycerol concentration of 2.1 to 4.6 mmol/L; glucose concentration of 6.1 to 6.9 mmol/L; SBP and DBP between 140 to 180 and 90 to 105 mmHg respectively; BMI > 27; smoking; sedentary; or family history of CVD Participants treated by hypolipaemic or hypoglycaemic drugs were excluded 102 participants were randomised to the Mediterranean diet group; mean age 50.8; 42% men 110 participants were randomised to the low‐fat diet group; mean age 51.6; 39.5% men
Interventions	The Mediterranean diet recommended nuts, wholemeal bread, cereals and a variety of raw or cooked, fresh or dried fruit and vegetables and legumes, with up to 35% to 38% of total energy intake as fat. Olive oil was recommended as the main source of added fat, and 50% of the energy provided by fat was to come from MUFAs, 25% from PUFAs and 25% from SFAs. Fish was recommended 4 times/week and red meat only 1 time/week. The recommended fibre intake was 25 g/day. The suggested red wine intake was 1 to 2 glasses per day. Dairy intake was limited by giving participants a calcium limit of 800 mg/day. The target for carotenoid intake was at 7 mg/day as a marker of fruit and vegetable intake. Dietary advice was given by physicians and dieticians and participants received a booklet with nutritional recommendations. In addition, participants were provided with oat‐bran enriched pasta, tomato sauce and olive oil. A commonly prescribed low‐fat American Heart Association–type diet was adapted for the low‐fat diet group. Recommendations were to eat more poultry than mammal meat, to avoid offal and saturated fat–rich animal products, and to eat fish 2 to 3 times/week. The consumption of raw and cooked fruit and vegetables, low‐fat dairy products and vegetable oils was recommended. Low‐fat diet recommendations limited fat intake to 30% of total energy, with 33% of energy from MUFAs, PUFAs and SFAs. The recommended fibre intake was 20 g/day and alcohol was to be avoided, especially for hypertriglyceridaemic participants. Cholesterol was restricted to 200 to 300 mg/day in both diets. To ensure adequate compliance with dietary recommendations, 3‐day food records (at inclusion and after 3 months) and 24‐hour unscheduled dietary recalls (once a month) were used by dieticians.The physical activity of the participants was recorded on questionnaires and did not differ at inclusion or at 3 months between the 2 groups. Follow‐up was at 3 months
Outcomes	Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, SBP, DBP
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states randomly assigned
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	43 participants dropped during 3 months. The characteristics of the dropouts were not significantly different from those of the other participants, but there was differential dropout, with 15.9% in the Mediterranean diet group and 35.8% in the low‐fat diet group.
Selective reporting (reporting bias)	Low risk	All outcomes stated are reported
Other bias	Unclear risk	Insufficient information to judge