Sofi 2018.

Methods	RCT of cross‐over design (cross‐over at 3 months)
Participants	Clinically healthy participants (18 to 75 years of age) with a low‐to‐moderate cardiovascular risk profile (< 5% at 10 years according to the European Society of Cardiology) recruited through advertisements in local media, newspapers, social media and websites from the Clinical Nutrition Unit of Careggi University Hospital, Florence, Italy, from March 2014 to June 2015. Eligibility criteria included being overweight (BMI ≥ 25) and the simultaneous presence of ≥ 1 of the following criteria: total cholesterol levels > 190 mg/dL, LDL cholesterol levels > 115 mg/dL, triglyceride levels > 150 mg/dL and glucose levels > 110 but < 126 mg/dL Participants were excluded if they were taking medications for any reason, had a serious illness or an unstable condition, were pregnant or nursing, were participating or had participated in a weight loss treatment programme in the last 6 months, or were following or had followed a food profile which, to a certain extent, excluded meat, poultry or fish in the last 6 months Median age 50 (range 21 to 75); 22% men; 118 participants randomised
Interventions	2 dietary interventions: Mediterranean diet and lacto‐ovo vegetarian diet Interventions were delivered through face‐to‐face, individual counselling sessions at the Clinical Nutrition Unit. Participants were provided with a detailed, 1‐week menu plan as well as tips and information on the food groups that could be included and those that could not. Both of the diets were low‐calorie in nature and acted as dietary interventions to reduce body weight or the risk parameters for cardiovascular disease. The vegetarian diet included recipes for preparing meals. Both diets were hypo caloric with respect to the energy requirements of the participants, but isocaloric between them, and consisted of ≈50% to 55% of energy from carbohydrate, 25% to 30% from total fat (≤ 7% of energy from saturated fat, < 200 mg/day of cholesterol) and 15% to 20% from protein. The vegetarian diet was characterised by abstinence from the consumption of meat and meat products, poultry, fish and seafood, and the flesh of any other animal. It included eggs and dairy products, as well as all the other food groups. The Mediterranean diet was characterised by the consumption of all the food groups, including meat and meat products, poultry and fish. There were no substantial differences in the frequency of servings per week for cereals, fruits and vegetables, potatoes, sweets and olive oil between the diets. As expected, a higher frequency of consumption, per week, of legumes (5 versus 2.5 servings), nuts (2 versus 1), eggs (2 versus 1), and dairy products (21.5 versus 18.5) was reported for the vegetarian diet compared to the Mediterranean diet. Follow‐up at 3 months
Outcomes	Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Notes	The 2 diets are very similar in terms of the components of the Mediterranean diet with the exception of low consumption of meat and meat products and increased consumption of fish for the Mediterranean diet Analysed as a parallel‐group design for the first 3‐month phase
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Used a web‐based online randomisation procedure
Allocation concealment (selection bias)	Low risk	Used a centralised service and it was not possible for the investigators to know the allocation sequence in advance
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	States that blinding of participants and dieticians is not possible because of obvious differences between the intervention diets. Blinding of participants and personnel for behavioural interventions is difficult and often not possible so we have not judged this as at high risk of bias.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Trial personnel who enrolled participants, outcome assessors and data analysts were blinded to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	9% and 10% loss to follow‐up in the intervention and comparison group respectively with reasons given
Selective reporting (reporting bias)	Low risk	Outcomes reported as detailed in the protocol
Other bias	Unclear risk	Insufficient information to judge