Lankinen 2014.

Study characteristics
Methods	Setting: Finland Design: parallel‐group RCT Dates: recruitment and screening October 2007 to November 2008, intervention periods were carried out during January 2008 to June 2009. Intervention duration: 12 weeks Follow‐up: no postintervention follow‐up Focus: to investigate the effects of whole grain, fish, and bilberries on serum metabolic profile and lipid transfer protein activities in people with metabolic syndrome.
Participants	N: 131 were randomised (34/42 completers in the whole grain intervention and 35/45 completers in the control group). Inclusion criteria: 40 to 70 years of age, impaired glucose metabolism (FPG 5.6 to 6.9 mmol/L) or in OGTT 2 hour (plasma glucose 7.8 to 11.0 mmol/L) and 2 of the following: BMI 26 to 39 kg/m2, waist circumference > 102 cm in men and > 88 cm in women, serum TG > 1.7 mmol/L, HDL < 1.0 mmol/L in men and < 1.3 mmol/L in women, or blood pressure >= 130 or >= 85 mmHg. Exclusion criteria: BMI > 40 kg/m2; fasting serum triglyceride concentration > 3.5 mmol/L; fasting serum cholesterol > 8 mmol/L; type 1 or 2 diabetes; abnormal liver, kidney, or thyroid function; large alcohol intake (women > 16, men > 24 doses (4 cL liquor or equivalent) during week); inflammatory bowel disease; disease that prevents participation; neuroleptic cortisone medication. Age (years): 40 to 70 years; mean age in whole grain enriched diet group 58 (SD 8) and in control group 59 (SD 7). Sex (% men): whole grain intervention: 50%, control: 51% Ethnicity: Caucasian (understood to be white) Baseline cardiovascular risk status: The study reports there was no difference in any of the baseline characteristics. BMI (kg/m2): whole grain intervention: 31.4 (SD 3.4); control: 31.0 (SD 3.6) Total cholesterol (mmol/L): whole grain intervention: 5.1 (SD 1.0); control: 5.4 (SD 1.0) HDL cholesterol (mmol/L): whole grain intervention: 1.2 (SD 0.4); control: 1.3 (SD 0.3) LDL cholesterol (mmol/L): whole grain intervention: 3.2 (SD 0.8); control: 3.4 (SD 0.8) Systolic blood pressure (mmHg): whole grain intervention: 135 (SD 16); control: 139 (SD 12) Diastolic blood pressure (mmHg): whole grain intervention: 86 (SD 8); control: 88 (SD 7) Medications used: Statins: 10/34 (29%) intervention; 9/35 (26%) control Hormonal replacement therapy: 4/34 (11%) intervention; 3/34 (9%) control Beta‐blocker or diuretics: 12/34 (35%) intervention; 9/35 (25.7%) control
Interventions	Whole grain diet group: whole grain wheat and rye bread Control: refined wheat foods Description of dietary intervention: the whole grain group replaced their habitual grain products with whole grain breads and a bread with low postprandial insulin response. Products covered 20% to 25% of total energy intake and were delivered to the participants. The fibre contents of the breads were 6.9% (endosperm rye bread), 6.4% (whole grain wheat bread), and 10% to 14% (commercial whole grain rye breads). 1 portion of habitually used grain product, e.g. a slice of low‐fibre wheat bread, was allowed daily to increase compliance. Pasta with a fiber content of 6% was also delivered and was instructed to be consumed at the dose equal to 3.5 dL of uncooked pasta per week. Participants were given whole grain oat biscuits of which they were allowed to consume 1 portion per day on a voluntary basis. Biscuits contained 8 to 8.5 g/100 g of dietary fibre and 16 to 18 g/100 g of fat, of which 4.3 to 7.7 g was saturated. The control group replaced their habitually used breads with refined wheat breads (dietary fiber 3 to 4.3 g/100 g) and other cereal products, e.g. pasta, with low‐fibre products (< 6 g/100 g dietary fibre). Participants were allowed to eat a maximum of 1 to 2 portions of rye products per day. Incentives: not reported Co‐interventions in both groups: none Assessment of dietary adherence: 4‐day food record at baseline, three 4‐day food records at weeks 3, 7, and 11. Was the diet energy reduced? no Comparability of diet composition: yes. In the whole grain group, the intake of total fat decreased, but there was no change in the quality of dietary fat. Fibre intake increased in the whole grain group, whereas it decreased in the control group. (See Table 2.) Change in diet over time: reported at baseline, 12 weeks. (See Table 2.)
Outcomes	Gene expression, glucose metabolism, plasma lipidomic profiles
Funding/conflicts of interest	Funding was provided by Academy of Finland (The Research Program on Nutrition, Foods and Health (ELVIRA), Decision number 117844 for MU and 117996 for MO), European Commission in the Communities 6th Framework Programme, Project HEALTHGRAIN (FOOD‐CT‐2005‐514008, for HM and KP), Sigrid Juselius Foundation, The Finnish Diabetes Research Foundation, Nordic Centre of Excellence on Systems Biology in Controlled Dietary Interventions and Cohort Studies (SYSDIET, 070014), TEKES 70103/06, The EVO‐fund of Kuopio University Hospital (5254), Fazer bakeries Oy, Vaasan & Vaasan Oy, KE Leipa¨ Oy, Leipomo Ruista¨hka¨, Leipomo Koskelonseutu, Raisio Oyj, Pakkasmarja Oy, Joswola Oy. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Notes	This was a 3‐arm RCT (HealthyDiet, not relevant to this review: whole grain and low postprandial insulin response grain products, fatty fish 3 times a week, and bilberries 3 portions per day; whole grain: whole grain and low postprandial insulin response grain products; control: refined wheat breads and cereal products).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The randomisation was conducted based on a randomisation table"
Allocation concealment (selection bias)	Unclear risk	"Participants were randomly assigned by the study nurse to one of the following groups: HealthyDiet, wholegrain or control"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated. In the CONSORT checklist they mention N/A.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reasons for attrition were reported and numbers provided: 24.4% in the control and 19% in the intervention.
Intention to treat analysis	Unclear risk	Analysis only reported for completers.
Selective reporting (reporting bias)	Low risk	All outcomes intended to measure in the protocol were reported.
Groups comparable at baseline	Low risk	Yes. "There were no significant differences in the characteristics between the groups at baseline"
Other bias	Unclear risk	Power calculations used glucose metabolism as outcome variable (not a primary outcome of this review), which required a sample size of 111 (37 in each group). This was nearly met, but power relevant to measuring changes in lipids or blood pressure not reported.