Kristensen 2012.

Study characteristics
Methods	Setting: Denmark (Copenhagen) Design: parallel‐group RCT Dates: not reported Intervention duration: 12 weeks (after a 2‐week run‐in period) Follow‐up: no postintervention follow‐up Focus: to compare energy‐restricted diets based on whole grain wheat compared to refined grain wheat in overweight or obese postmenopausal women.
Participants	N: 79 were randomised after the run‐in period, and a total of 72 women completed the study (38/42 in the whole grain wheat group and 34/37 in the refined grain wheat group). Inclusion criteria: BMI 27 to 37 kg/m2, age 45 to 70 years, and 1‐year postmenopausal (self reported). Exclusion criteria: smoking, chronic illnesses (diabetes or CVD), untreated hypertension (> 160/100 mmHg), elevated fasting total cholesterol (> 6.5 mmol/L) or glucose (> 7.0 mmol/L), use of dietary supplements, food dislikes or intolerances relevant to the study, and use of medications (except antihypertensives). Age (years): 45 to 70 years, otherwise not reported. Sex (% men): 0% (all female) Ethnicity: Danish (ethnic composition not reported) Baseline cardiovascular risk status: The study reports there was no difference in any of the baseline characteristics. BMI (kg/m2): whole grain intervention: 30.0 (SEM 0.4); control: 30.4 (SEM 0.6) Total cholesterol (mmol/L): whole grain intervention: 5.57 (SEM 0.16); control: 5.61 (SEM 0.14) HDL cholesterol (mmol/L): whole grain intervention: 1.24 (0.04 SEM); control: 1.28 (0.04 SEM) LDL cholesterol (mmol/L): whole grain intervention: 3.75 (0.16 SEM); control: 3.75 (0.13 SEM) Systolic blood pressure (mmHg): whole grain intervention: 133 (2 SEM); control: 138 (4 SEM) Diastolic blood pressure (mmHg): whole grain intervention: 85.5 (1.4 SEM); control: 87.3 (1.6 SEM) Medications used: 10 women in each group used antihypertensive medications.
Interventions	Whole grain diet group: whole grain wheat Control: refined wheat foods Description of dietary intervention: whole grain wheat foods as part of an energy‐restricted diet to provide 105 g of whole grains daily. The whole grain or refined grain foods were intended to replace ~2 MJ of the participants' habitual diet, and both groups were asked to consume 62 g of bread, 60 g pasta (uncooked), and 28 g of biscuits daily. There was no restriction on consumption of other cereal products. Both groups were asked to consume an energy‐restricted diet with a deficit of at least 1250 kJ/d but not less than 5000 kJ/d, with minimum protein intake of 60 g/d. The participants met with a dietitian at least 5 times during the study. Food provided biweekly. Incentives: not reported Co‐interventions in both groups: none Assessment of dietary adherence: food diary (self reported) (note only 57 of 72 women who completed the study kept food diaries eligible for data analysis). Was the diet energy reduced? yes (~1250 kJ/d deficit) Comparability of diet composition: total self reported energy intake similar at weeks 1 to 6: whole grain 5830 kJ/d (SEM 190) and refined grain 5900 kJ/d (SEM 280), but higher in refined grain group for weeks 7 to 12: whole grain 6060 kJ/d (SEM 150) and refined grain 6330 (SEM 180) kJ/d. Carbohydrate also appears to be higher in the refined grain group, but SEM and P values not reported. (See Table 2.) Change in diet over time: reported at 4, 8, 12 weeks. (See Table 2.)
Outcomes	Systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, glucose, insulin, HOMA‐IR, glycated haemoglobin, hsCRP, IL‐6, body weight, BMI, waist circumference, FFM.
Funding/conflicts of interest	European Commission in the Communities 6th Framework Programme, Project HEALTHGRAIN (FOOD‐CT‐2005‐514008), the University of Copenhagen, Faculty of Life Sciences and LMC FOOD Research School. Authors M Petronio and G Riboldi are employed by Barilla, and AB Ross is employed by Nestle.
Notes	There was a concomitant increase in energy intake and carbohydrate intake in the refined grain group. Authors report that non‐compliance in the refined grain group did not reflect a lack of intake of refined grain foods, but instead was due to high intake of whole grain products other than the foods provided.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"participants were randomly allocated", but method not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Loss to follow‐up and reasons for dropout similar in both groups. Whole grain 4/42 lost, refined grain 3/37 lost. However, only 57 of 72 food diaries eligible for analysis, reasons not reported.
Intention to treat analysis	Unclear risk	Intention‐to‐treat analysis performed for anthropometric outcomes, no differences in ITT analysis compared to completers. Intention‐to‐treat analysis not done for lipids and blood pressure outcomes.
Selective reporting (reporting bias)	Unclear risk	Only 57 of 72 food diaries eligible for analysis, reasons not reported.
Groups comparable at baseline	Low risk	States no difference.
Other bias	Unclear risk	Power calculations used weight as outcome variable (not a primary outcome of this review), which required a sample size of 72 (36 in each group). This was met, but power relevant to measuring changes in lipids or blood pressure not reported.