Katcher 2008.

Study characteristics
Methods	Setting: USA Design: parallel RCT with stratified randomisation by sex (male or female) and BMI status (BMI < 40 or >/= 40 kg/m2). Dates: trial opened to accrual September 2005, enrolment completed August 2006. Intervention duration: 12 weeks Follow‐up: no postintervention follow‐up Focus: to determine whether including whole grain foods in a hypocaloric (reduced by 500 kilocalories/d) diet enhances weight loss and improves CVD risk factors in obese adults with metabolic syndrome.
Participants	N: 50 randomised (24/25 completers in the whole grain intervention group and 23/25 in the control group). Inclusion criteria: men and women were eligible if they had a BMI (in kg/m2) >/= 30 and met 3 of 5 National Cholesterol Education Program Adult Treatment Panel III criteria for metabolic syndrome: triacylglycerol concentrations >/= 150 mg/dL, HDL cholesterol concentrations < 40 mg/dL in men or < 50 mg/dL in women, fasting glucose concentrations >/= 100 mg/dL, systolic blood pressure >/= 30 mmHg or diastolic blood pressure >/= 85 mmHg (or both), waist circumference >/= 102 cm in men or 88 cm in women. Exclusion criteria: diagnosed with type 1 or 2 diabetes, CVD, cancer, or any other serious medical condition or if they were using any medications known to affect glucose, insulin, cholesterol, or reproductive hormones; people who smoked, drank > 2 alcoholic beverages/d, or consumed a diet high in whole grains (> 3 servings/d); or who were pregnant or lactating. Age (years): 24 to 63 years. Whole grain group mean age: 45.4 (SD 8); refined grain group mean age 46.6 (SD 9.7). Sex (% men): whole grain group: 48%; refined grain group: 52% Ethnicity: US (48/50 white; 1/50 African‐American; 1/50 Hispanic) Baseline cardiovascular risk status: BMI (kg/m2): whole grain intervention: 35.54 (4.1); control: 36.1 (4.9) Total cholesterol mmol/L: whole grain intervention: 4.91 (1.22); control: 4.86 (0.64) LDL cholesterol, mmol/L: whole grain intervention: 3.08 (1.02); control: 2.96 (0.51) HDL cholesterol, mmol/L: whole grain intervention: 1.07 (0.23); control: 1.06 (0.2) Systolic blood pressure (mmHg): whole grain intervention: 123 (9.4); control: 130.3 (13.3), P = 0.03 Diastolic blood pressure (mmHg): whole grain intervention: 83.2 (8.3); control: 82.0 (7.5) Medications used: not reported, other than that participants on medications known to affect glucose, insulin, cholesterol, or reproductive hormones were excluded.
Interventions	Whole grain diet group: based on a range of whole grains Control: refined cereal foods Description of dietary intervention: The whole grain group were given a target number of daily whole grain servings (4, 5, 6, or 7 servings/d) based on their energy needs. The whole grain group were given a list and description of whole grain foods to help them identify foods to include in their diet, and they were encouraged to select foods for which a whole grain was listed as the first ingredient. They were advised to consume 3 daily servings of whole grain foods for the first 2 wks of the study, and then to increase to their target number of daily whole grain servings for the remaining 10 wks. Participants in the refined grain group were also given a list of whole grain foods and were asked not to consume any of these foods during the study period. A registered dietitian met individually with each participant at baseline to discuss the dietary intervention and provided educational materials. Additionally, both groups were asked to eat 5 servings of fruits and vegetables, 3 servings of low‐fat dairy products, and 2 servings of lean meat, fish, or poultry, per day, based on 2005 dietary guidelines for Americans. The target macronutrient composition was 55% of energy as carbohydrate, 30% of energy as fat (with an emphasis on unsaturated fats), and 15% of energy as protein. Incentives: not reported Co‐interventions in both groups: participants in both groups were encouraged to engage in moderate physical activity for 30 min per session 3 times/wk. Assessment of dietary adherence: 3‐day diet record (and a diet satisfaction questionnaire) Was the diet energy reduced? yes (target energy deficit ~500 kilocalories/d) Comparability of diet composition: yes. Energy intake decreased (P < 0.001) from baseline in both diet groups (as both were weight loss diets). The percentage of energy from carbohydrate and protein increased (P < 0.01), and from fat decreased (P < 0.001) in both diet groups compared with baseline. Participants in the whole grain group increased their intake of total, insoluble, and soluble fibre by 50%, 52%, and 47%, respectively, and those in the refined grain group increased their intakes by 7%, 5%, and 14%, respectively. (See Table 2.) Change in diet over time: as above
Outcomes	Systolic and diastolic BP; lipids (LDL cholesterol, HDL cholesterol, triacylglycerol); anthropometric measures, including weight and BMI; apolipoprotein A1/B; glycaemic measures; satisfaction with diet.
Funding/conflicts of interest	General Mills Bell Institute of Health and Human Nutrition, grant no. K24 HD01476 and M01 RR10732 from the National Institutes of Health, and construction grant no. C06 RR016499 (to the General Clinical Research Center of The Pennsylvania State University).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Participants were assigned to either a whole grain or refined‐grain hypocaloric diet with the use of a stratified randomization scheme"
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	Low risk	Attrition and reasons for loss to follow‐up fully reported.
Intention to treat analysis	Unclear risk	Analysis only reported for completers.
Selective reporting (reporting bias)	Unclear risk	All outcomes fully reported, but not enough information to judge.
Groups comparable at baseline	Unclear risk	Yes, except for systolic BP and the percentage of the LDL‐III subclass, which were higher (P=0.03) at baseline in the refined grain group than in the whole grain group; however, there were no other differences at baseline between the groups.
Other bias	Unclear risk	Power calculations used weight as outcome variable (not a primary outcome of this review), which required a sample size of 50. This was met, but power relevant to measuring changes in lipids or blood pressure not reported.