Giacco 2013.

Study characteristics
Methods	Setting: Finland (Kuopio) and Italy (Naples) Design: parallel groups (with stratification for sex, age, and BMI). Dates: March 2008 to May 2014 Intervention duration: 12 weeks Follow‐up: no postintervention follow‐up Focus: to compare the effects of diets containing whole grain rye or wheat cereals compared to refined grains on markers of metabolic syndrome in people with metabolic syndrome.
Participants	N: 146 randomised (62/71 completers in the whole grain intervention group and 61/75 in the control group). Inclusion criteria: male and female, aged 40 to 65 years, with metabolic syndrome (diagnosed on National Cholesterol Education Program criteria). Exclusion criteria: diabetes and/or renal failure (serum creatinine > 1.5 mg/dL), liver abnormalities (ALT/AST ratio 2 times above normal values), anaemia (haemoglobin < 12 g/dL), any other chronic disease, or if they used any drug able to influence glucose and lipid metabolism and inflammation (corticosteroid hormones other than inhaled corticosteroids, hypolipidaemic and/or anti‐inflammatory drugs); however, in the Kuopio study centre the use of cholesterol lowering medications (statins) was allowed. Age (years): 40 to 65 years, otherwise not reported. Sex (% men): whole grain intervention: 46.9%; control: 47.5% Ethnicity: Italian and Finnish (ethnic composition not reported) Baseline cardiovascular risk status: BMI (kg/m2): whole grain intervention: 31.6 (4.6); control: 31.3 (4.4) Total cholesterol (mmol/L): whole grain intervention: 5.15 (1.09); control: 5.28 (0.93) HDL cholesterol (mmol/L): whole grain intervention: 6 (0.36); control: 4 (0.31) LDL cholesterol (mmol/L): whole grain intervention: 3.26 (0.98); control: 3.41 (0.80) Systolic blood pressure (mmHg): whole grain intervention: 133 (15); control: 135 (14) Diastolic blood pressure (mmHg): whole grain intervention: 84 (9); control: 86 (8) Medications used: in the Kuopio study centre, some individuals were using cholesterol‐lowering medication (10 in the whole grain intervention group and 10 in the control group), however sensitivity analyses were conducted after excluding these people.
Interventions	Whole grain diet group: (wheat and rye whole grain) Control: (refined cereal foods), differed between centres Description of dietary intervention: whole grain wheat and rye products (and smaller amounts of oat and barley), most with a low postprandial glucose and/or insulin response. The only difference between the whole grain and the control diet was the inclusion of a fixed amount of whole grain or refined cereal products as the main carbohydrate source. Aimed to include 90% sourdough bread and 10% endosperm rye bread. Naples ‐ whole grain products including whole wheat bread (plus some endosperm rye bread), whole wheat pasta, barley kernels, whole grain oat biscuits and breakfast cereals (all bran sticks and flakes). Kuopio ‐ whole grain and control diets aimed to include 20% to 25% of the total daily energy intake as study breads. The type of bread consumed by the Kuopio participants was 50% commercial whole grain rye bread, 40% endosperm rye bread, and 10% sourdough whole wheat bread, and participants were advised to replace their habitual potato consumption with 210 g dry weight of whole wheat pasta per week, and were given whole oat biscuits for snacks. Test products in both diets provided free of charge on a weekly basis. Also given written instructions and recipes. Incentives: not reported Co‐interventions in both groups: none Assessment of dietary adherence: 4‐day and 7‐day food records and plasma alkylresorcinols Was the diet energy reduced? no Comparability of diet composition: energy intake increased in intervention and control groups P < 0.02 from baseline, but no significant difference between groups at 12 wks. Significant increased protein, PUFA, total fibre, and cereal fibre between WG group and control at 12 wks (P < 0.05). (See Table 2.) Change in diet over time: not reported
Outcomes	Peripheral insulin sensitivity assessed by FSIGT, lipids and inflammatory markers, body weight, blood pressure, waist circumference, short‐chain fatty acids
Funding/conflicts of interest	European Commission (6th Framework Programme, project HEALTHGRAIN FOOD‐CT‐2005‐514008), Raisio plc Research Foundation (Raisio is a commercial organisation that makes cereal products), the Nordic Centre of Excellence (projects HELGA and SYSDIET). Barilla G&R F.lli.SpA, Parma, Italy and Raisio Nutrition Ltd, Finland provided some of the cereal products for the study participants.
Notes	Stable body weight, body fat composition, and waist circumference maintained during the intervention.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was carried out by means of a computerised random allocation list.
Allocation concealment (selection bias)	Low risk	Allocation was carried out by personnel not involved in the study.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Anthropometric data collection does not appear to have been blind (secondary outcome). Lipid analysis appears to have been blind.
Incomplete outcome data (attrition bias) All outcomes	High risk	Differential rates of attrition between groups, and characteristics of those lost to follow‐up not reported (62/71 completers in the whole grain intervention group and 61/75 in the control group).
Intention to treat analysis	Unclear risk	Not reported. Only outcomes for completers reported, so probably not done.
Selective reporting (reporting bias)	Unclear risk	Reports all relevant outcomes, but not enough information to judge.
Groups comparable at baseline	Low risk	Comparable for lipids (total, HDL, LDL, TAG), blood pressure, anthropometry, and age
Other bias	Unclear risk	Power calculations used insulin sensitivity as outcome variable (not a primary outcome of this review). Power relevant to lipids, blood pressure, or BMI not reported. The 2 centres had different nutritional constituent parts and respective controls. 10 participants in each group had lipid‐lowering medications.