Landers 2002.

Study characteristics
Methods	Review comparison(s) addressed by this study: 1 Study design: RCT, parallel, number of centres NR Trial registry number: NR Total number of trial arms: 3 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: NA Other notes about methods: NA
Participants	Country and setting: NR; likely USA based on authors and journal Eligibility criteria: Participants aged 18 to 55 who were obese with BMI > 27 kg/m2 and had certification from a primary care physician. Participants were excluded if they had a history of kidney or liver disease; were pregnant or lactating, medicated for hypertension; had diabetes or hypercholesterolemia. 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Mixed Total number randomised: 91 Total attrition in trial: 42 Treatment diet Participants randomised: 28 Participants withdrawn (voluntary): NR Total attrition: 12 Control diet: Participants randomised: 33 Participants withdrawn (voluntary): NR Total attrition: 12 Baseline data treatment diet: Randomised participants not included: NR Age (years): NR Gender distribution (as reported): NR Weight (kg): NR BMI (kg/m2): NR 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: NR Age (years): NR Gender distribution (as reported): NR Weight (kg): NR BMI (kg/m2): NR 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: NR Characteristic(s) with significant group difference and relevant statistic: NA Other notes about participants: NA
Interventions	Energy (E) comparison of treatment vs control diets: Different ‐ ad libitum in treatment diet and restricted in control diet Treatment diet: Name (as reported) and brief description: Low‐carbohydrate high‐protein (LCHP) ad libitum diet; participants were instructed to maintain carbohydrate intake of less than 30 g/day and dietitian calculated the minimum grams of high biological value (HBV) protein to be eaten daily. Treatment diet type (carbohydrate‐fat‐protein): Very low‐unclear‐unclear Exercise component? No Recipients: Healthy adults aged 18 to 55 years, with a BMI > 27 kg/m2 Why? To determine changes in lean body mass and fat mass using a DEXA scan on ketogenic diets What (materials)? Diet materials (not specified), sample menus and carbohydrate counting booklets What (procedures)? Based on the measurement of lean body mass (DEXA), the minimum daily amount of high biological value protein (HBV) was calculated. Participants were instructed on HBV sources. A carbohydrate counter booklet assisted them in maintaining their carbohydrate intake at < 30 grams per day. They were encouraged to use salt and Morton Lite Salt ad libitum to supplement duiretic losses of sodium and potassium. Participants were instructed to continue their current physical activity, to drink at 64 oz of non‐caffeinated calorie‐free fluid per day and take a multiple vitamin and mineral supplement. No specific exercise routine was recommended. Who provided? Dietitian How and where? Individualised face‐to‐face counselling at the clinic When and how much? Weekly (12 visits). At each follow‐up visit the diet was reinforced. Strategies to improve or maintain fidelity; tailoring and modification: Participants recorded their food intake in a diary; this diary was reviewed weekly. They were weighed and also provided a weekly urine specimen to check for ketones. Extent of intervention fidelity: The extent of dietary non‐compliance was NR for this intervention group. However, the study authors reported the following:" ... it was evident that some subjects were non‐compliant to the diet." ; "LCHP dieters did not consistently spill ketones in the urine"; "There were subjects on LCHP diets who continued to eat beans, cornbread, and other starchy foods on a regular basis despite weekly education". Concomitant interventions: NR Control diet: Name (as reported) and brief description: Conventional diet; macronutrient distribution of 50% carbohydrate, 20% protein and 30% fat. Energy prescription was based on adjusted body weight and the Harris‐Benedict equation to estimate energy needed to promote 0.45 kg weight loss per week. Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐balanced Exercise component? No Recipients: Healthy adults aged 18 to 55 years, with a BMI > 27 kg/m2 Why? To provide data on body composition changes on a conventional weight loss diet, such as the amount of lean and fat mass) during periods of weight loss What (materials)? Diet plans were based on the diabetic exchange lists and each subject received a customised sample meal plan as well as a copy of Exchange lists for meal planning. A food diary was also provided. What (procedures)? Using adjusted body weight (actual weight ‐ ideal weight) * 0.25 + ideal body weight) and the Harris Benedict equation estimated energy needed to promote weight loss of 0.45kg. No subject was given a diet less than 1200 kCal. All subjects were instructed to continue their physical activity, drink at least 64 oz of non‐caffeinated calorie‐free fluid per day, take a multiple mineral and vitamin supplements. Who provided? Dietitian How and where? Individualised face‐to‐face counselling at the clinic When and how much? Weekly (12 visits). At each follow‐up visit the diet was reinforced. Strategies to improve or maintain fidelity; tailoring and modification: Participants recorded their food intake in a diary; this diary was reviewed weekly. They were also weighed. Extent of intervention fidelity: The extent of dietary non‐compliance was NR for this intervention group. Concomitant interventions: NR
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: NR Declaration of interest: NR