Farnsworth 2003.

Study characteristics
Methods	Review comparison(s) addressed by this study: 1, 2 Study design: RCT, parallel, number of centres NR 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: 12 weeks What was the duration of the weight maintenance phase: 56 weeks Other notes about methods: NA
Participants	Country and setting: NR; likely Australia based on authors and food suppliers Eligibility criteria: Participants were overweight or obese (BMI of 27 to 43 kg/m2) and aged 20 to 65 years, and had to have a fasting serum insulin concentration of > 12 mU/L. Participants were excluded if they had diabetes or proteinuria; a history of liver, unstable cardiovascular, respiratory or gastrointestinal disease or had a malignancy (or history thereof). Type 2 diabetes at baseline: No Impaired glucose tolerance at baseline: Unclear Cardiovascular conditions/risk factors/events at baseline: No Gender: Mixed Total number randomised: 66 Total attrition in trial: 9 Treatment diet Participants randomised: 33 Participants withdrawn (voluntary): NR Total attrition: NR Control diet: Participants randomised: 33 Participants withdrawn (voluntary): NR Total attrition: NR Baseline data treatment diet: Randomised participants not included: 5/33 Age (years): mean (SD) 50.93 (11.43) Gender distribution (as reported): female 21/28 (75%), male 7/28 (25%) Weight (kg): mean (SD) 93.98 (13.54) BMI (kg/m2): mean (SD) 34.30 (3.82) DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): mean (SD) 3.77 (0.94) HDL (mmol/L): mean (SD) 0.98 (0.22) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 5.55 (1.12) TG (mmol/L): mean (SD) 1.88 (0.72) Baseline data control diet: Randomised participants not included: 4/33 Age (years): mean (SD) 50.12 (9.43) Gender distribution (as reported): female 22/29 (75.9%), male 7/29 (24.1%) Weight (kg): mean (SD) 93.39 (14.31) BMI (kg/m2): mean (SD) 33.82 (3.75) DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): mean (SD) 3.76 (0.82) HDL (mmol/L): mean (SD) 0.97 (0.25) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 5.59 (0.85) TG (mmol/L): mean (SD) 1.88 (0.60) Group differences at baseline: No Characteristic(s) with significant group difference and relevant statistic: NA Other notes about participants: Number of participants not included in baseline characteristics for total cholesterol, LDL, HDL and triglycerides: intervention 5/33; control 5/33
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 diet: 30% of energy as protein, 40% as carbohydrate, and 30% as fat 8% of energy as saturated, 12% as monounsaturated, and 5% as polyunsaturated fatty acids. Energy restriction of 6400 kJ per day on average Treatment diet type (carbohydrate‐fat‐protein): Low‐balanced‐high Exercise component? No Recipients: N = 7 men and N = 21 women, mean (SD) age 50.93 (11.43) years, mean (SD) weight 93.98 (13.54) kg, mean (SD) BMI 34.3 (3.82) kg/m2, with fasting insulin levels greater than 12 mU/L (mean 16 mU/L). Why? "There are no data on the effects of high‐protein diets on changes in bone resorption and blood pressure after moderate weight loss. HP diet would spare lean mass and result in greater decreases in fasting and postprandial insulin concentrations." What (materials)? The diets were prescriptive fixed‐menu plans, and subjects were supplied with key foods that made up 60% of their energy intake. The key foods supplied to both diet groups were preweighed meat and poultry, shortbread biscuits, canola margarine (Canola Lite; Meadow Lea Foods Ltd, Mascot, Australia), and high‐oleic acid sunflower oil (Sunola; Meadow Lea Foods Ltd). The HP diet group also received low‐fat (3% fat) cheese (Kraft Free; Kraft Foods Ltd, Melbourne, Australia) and skim milk powder. What (procedures)? Participants were prescribed a HP diet: 30% of energy as protein (= 110 g/d), 40% as carbohydrate, and 30% as fat for 16 weeks. The fatty acid profiles for each diet were matched (8% of energy as saturated, 12% as monounsaturated, and 5% as polyunsaturated fatty acids). Each subject completed weighed daily checklists of all foods consumed. Group training in the use of scales and in keeping food records was provided. Both dietary groups underwent 12 wks of energy restriction (roughly 30% restriction of total energy, or 6.4 MJ on average), followed by 4 wks of energy balance with the same macronutrient composition. Participants also recorded physical activity. Who provided? Dietitian How and where? The study was conducted on an outpatient basis, location NR. When and how much? 2‐wk intervals over 16 weeks according to the method described by Parker et al (25) Strategies to improve or maintain fidelity; tailoring and modification: Each subject completed weighed daily checklists of all foods consumed and was assessed by the same dietitian at 2‐wk intervals according to the method described by Parker et al Extent of intervention fidelity: As prescribed protein was higher and the carbohydrate was lower with the HP diet. Concomitant interventions: Anti‐hypertensive or lipid lowering medication and supplements Control diet: Name (as reported) and brief description: Standard protein diet: 15% of energy as protein, 55% as carbohydrate, and 30% as fat with 8% of energy as saturated, 12% as monounsaturated, and 5% as polyunsaturated fatty acids. Energy restriction of 6400 kJ per day on average Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐balanced Exercise component? No Recipients: N = 7 men and N = 22 women, mean (SD) age 50.12 (9.43) years, mean (SD) weight 93.39 (14.31) kg, mean (SD) BMI 33.82 (3.75) kg/m2, with fasting insulin levels greater than 12 mU/L ( mean 16 mU/L) Why? NR What (materials)? The diets were prescriptive fixed‐menu plans, and subjects were supplied with key foods that made up 60% of their energy intake. The key foods supplied to both diet groups were preweighed meat and poultry, shortbread biscuits, canola margarine (Canola Lite; Meadow Lea Foods Ltd, Mascot, Australia), and high‐oleic acid sunflower oil (Sunola; Meadow Lea Foods Ltd). The SP diet group received rice and rice noodles. What (procedures)? Participants were prescribed a SP diet: 15% of energy as protein (roughly 60 g/d), 55% as carbohydrate, and 30% as fat. The fatty acid profiles for each diet were matched (8% of energy as saturated, 12% as monounsaturated, and 5% as polyunsaturated fatty acids). Both dietary groups underwent 12 wks of energy restriction (roughly 30% restriction of total energy, or 6.4 MJ on average), followed by 4 wks of energy balance with the same macronutrient composition. A weighed daily checklist of all foods consumed was required and a dietitian assessed the diet individually every 2 weeks. Also, group training in the use of scales and in keeping food records was provided. Who provided? Dietitian How and where? The study was conducted on an outpatient basis, location NR. When and how much? 2‐wk intervals over 16 weeks according to the method described by Parker et al (25) Strategies to improve or maintain fidelity; tailoring and modification: Each subject completed weighed daily checklists of all foods consumed and was assessed by the same dietitian at 2‐wk intervals according to the method described by Parker et al Extent of intervention fidelity: NR Concomitant interventions: Anti‐hypertensive or lipid lowering medication and supplements
Outcomes	Change in body weight (kg) at 3 to < 12 months: Yes Change in body weight (kg) at ≥ 12 months: No 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: National Health and Medical Research grant 158012 and Dairy Research and Development Corporation grant CSHN10003 Declaration of interest: "None of the authors had financial or personal conflicts of interest."