Benassi‐Evans 2009.

Study characteristics
Methods	Review comparison(s) addressed by this study: 1 Study design: RCT, parallel, single‐centre (1) Trial registry number: NR Total number of trial arms: 2 Year trial started: NR Sample size calculation: No Outcome(s) used for sample size calculation: NA Duration of run‐in period (weeks): NA What was the duration of the weight loss phase: 52 weeks What was the duration of the weight maintenance phase: NA Other notes about methods: NA
Participants	Country and setting: Australia, outpatient clinic in Adelaide Eligibility criteria: Participants were males aged 20 to 65 with a BMI of 27 to 40 kg/m2 and at least one additional risk factor for cardiovascular disease; as well as no history of metabolic or coronary disease or type 1 or 2 diabetes. Exclusion criteria NR Type 2 diabetes at baseline: No Impaired glucose tolerance at baseline: Unclear Cardiovascular conditions/risk factors/events at baseline: No Gender: Male Total number randomised: 33 Total attrition in trial: NR Treatment diet Participants randomised: 16 Participants withdrawn (voluntary): NR Total attrition: NR Control diet: Participants randomised: 17 Participants withdrawn (voluntary): NR Total attrition: NR Baseline data treatment diet: Randomised participants not included: None Age (years): mean (SE) 54.94 (1.17) Gender distribution (as reported): female 0%, male 100% Weight (kg): mean (SE) 99.84 (2.45) BMI (kg/m2): mean (SE) 32.42 (0.79) DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): NR HDL (mmol/L): NR Non‐HDL (mmol/L): NR TC (mmol/L): NR TG (mmol/L): NR Baseline data control diet: Randomised participants not included: None Age (years): mean (SE) 52.94 (1.50) Gender distribution (as reported): female 0%, male 100% Weight (kg): mean (SE) 99.58 (3.61) BMI (kg/m2): mean (SE) 31.47 (0.96) DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): NR HDL (mmol/L): NR Non‐HDL (mmol/L): NR TC (mmol/L): NR TG (mmol/L): NR Group differences at baseline: No Characteristic(s) with significant group difference and relevant statistic: NA Other notes about participants: NA
Interventions	Energy (E) comparison of treatment vs control diets: Similar energy prescription/approach to restrict energy intake in both diets Treatment diet: Name (as reported) and brief description: High‐protein high red meat (HP) diet. Consisted of 35% protein, 40% carbohydrate and 25% fat. Total energy content was 7000 kJ. Treatment diet type (carbohydrate‐fat‐protein): Low‐balanced‐high Exercise component? No Recipients: Men only N = 16, mean (SE) age 54.94 (1.17) years, mean (SE) weight 99.84 (2.45) kg, mean (SE) BMI 32.42 (0.79) kg/m2. Why? "...we anticipated that the expected increased intake in the HP diet of folate, vitamin B12, niacin, vitamin E and calcium might result in lower peripheral blood lymphocytes (PBL), MN frequency given that higher intake of these vitamins is associated with lower MN frequency in PBLs in previous studies." What (materials)? Food checklists What (procedures)? Participants were prescribed a high protein–high red meat (HP) diet (35% protein, 40% carbohydrate, 25% fat). The total energy content of both diets was 7000 kJ, with some adjustments in energy (while maintaining protein to energy ratios) necessary for individuals to achieve an approximate weight loss of 1 kg per week. Twelve‐week intensive weight loss phase and 1 year maintenance phase continuing with the same diet strategy that the participant consumed in the 1st 12 weeks. Dietitian consultations were provided over the whole 1 year period with checklists being issued every 4 weeks. Who provided? Dietitian How and where? Face‐to‐face individual consultations, location NR When and how much? Fortnightly clinic visits during weight loss phase (12 weeks), thereafter monthly during weight maintenance phase (until 1 year) Strategies to improve or maintain fidelity; tailoring and modification: Dietary intake for 6 days/month was analysed from the checklists using FoodWorks dietary analysis package. Extent of intervention fidelity: The HP‐diet group recorded a significantly greater intake of protein, folate and iron at both weeks 12 and 52. Fibre and calcium intake was significantly higher in the HP group at week 12 only, while total fat intake was recorded as significantly higher in the HP group for week 52 only. Concomitant interventions: NR Control diet: Name (as reported) and brief description: High‐carbohydrate low red meat (HC) diet. Consisted of 17% protein, 58% carbohydrate and 25% fat. Total energy content was 7000 kJ. Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐balanced Exercise component? No Recipients: Men only N = 17, mean (SE) age 52.94 (1.50) years, mean (SE) weight 99.58 (3.61) kg, mean (SE) BMI 31.47 (0.96) kg/m2. Why? NR What (materials)? Food checklists What (procedures)? Participants were prescribed a high carbohydrate–low red meat (HC) diet (17% protein, 58% carbohydrate, 25% fat). The total energy content of both diets was 7000 kJ, with some adjustments in energy (while maintaining protein to energy ratios) necessary for individuals to achieve an approximate weight loss of 1 kg per week. Who provided? Dietitian How and where? Face‐to‐face individual consultations, location NR When and how much? Fortnightly clinic visits during weight loss phase (12 weeks), thereafter monthly during weight maintenance phase (until 1 year) Strategies to improve or maintain fidelity; tailoring and modification: Dietary intake for 6 days/month was analysed from the checklists using FoodWorks dietary analysis package. Extent of intervention fidelity: The HP‐diet group recorded a significantly greater intake of protein, folate and iron at both weeks 12 and 52. Fibre and calcium intake was significantly higher in the HP group at week 12 only, while total fat intake was recorded as significantly higher in the HP group for week 52 only. Concomitant interventions: NR
Outcomes	Change in body weight (kg) at 3 to < 12 months: Yes Change in body weight (kg) at ≥ 12 months: Yes Number of participants with 5% weight loss from baseline at 3 to < 12 months: No Number of participants with 5% weight loss from baseline at ≥ 12 months: No Change in BMI (kg/m2) at 3 to 12 months: No Change in BMI (kg/m2) at ≥ 12 months: No Number of participants with 5% BMI reduction from baseline at 3 to 12 months: No Number of participants with 5% BMI reduction from baseline at ≥ 12 months: No Change in DBP (mmHg) at ≥ 12 months: No Change in SBP (mmHg) at ≥ 12 months: No All‐cause mortality at ≥ 12 months: No Cardiovascular mortality at ≥ 12 months: No Non‐fatal myocardial infarction at ≥ 12 months: No Non‐fatal stroke at ≥ 12 months: No Diagnosis of type 2 diabetes mellitus at ≥ 12 months: No Change in HbA1c (%) at ≥ 12 months: No Change in LDL (mmol/L) at ≥ 12 months: No Change in HDL (mmol/L) at ≥ 12 months: No Change in non‐HDL (mmom/L) at ≥ 12 months: No Change in total cholesterol (TC) (mmol/L) at ≥ 12 months: No Change in triglycerides (or triacylglycerides) (TG) (mmol/L) at ≥ 12 months: No Participant‐reported adverse effects: No
Notes	Number and type of records(s): journal article Trial acronym/name: None Trial funded by: Meat and Livestock Australia (Medical Research Grant) Declaration of interest: "None declared."