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. 2015 Oct 20;10(10):e0139817. doi: 10.1371/journal.pone.0139817

Table 1. Randomized clinical trials included in the meta-analyses: study characteristics.

Lead Author Year Calorie Restriction Key Enrollment Criteria Primary Endpoint(s) Randomization Outcomes Reported Dropout Study Power For Between Group Effect Duration
Bradley 2009 500 kcal deficit per day in each group BMI≥27 Insulin resistance (euglycemic-hyperinsulin-emic clamp) Random number generator, blocked Completers reported Specifics not disclosed Insulin Sensitivity 8 weeks
Brehm 2003 ad libitum LoCHO vs. calorie restricted LoFAT BMI = 30–35 Weight and LDL Specifics not disclosed ITT with LOCF/BOCF with completers reported separately Reasons listed Specifics not disclosed 6 months
Brehm 2005 ad libitum LoCHO with ketosis vs. calorie restricted LoFAT Women, BMI = 30–35 Resting energy expenditure Randomization blocked, computer generated Completers reported Reasons listed Specifics not disclosed 4 months
Brinkworth 2009 isocaloric with moderate energy restriction for both groups; Women~1429 & men~1667 kcal/d Abdominal obesity + at least one risk factor for metabolic syndrome Weight & Metabolic Effect Specifics not disclosed Completers reported Reasons listed Specifics not disclosed 1 year
Dansingera 2005 None BMI = 27–42 + at least one risk factor for metabolic syndrome Weight Computer generated, stratified ITT (LOCF) with completers reported separately Reasons listed Weight at Δ = 3% (or Δfrom baseline for each of 2%) 1 year
de Luis 2012 both calorie-restricted, ~1500kcal/day BMI>30 Weight Disclosed via envelope All patients completed All completed Weight: power calculation stated differently in related publications 3 months
Flechter-Mors 2010 500 kcal deficit per day metabolic syndrome, BMI = 27–45 Weight & body comp Specifics not disclosed Completers with ITT (LOCF) reported separately Reasons listed Specifics not disclosed 1 year
Fosterb 2003 caloric restriction in low fat group obese Weight Random number generator Actual data, not imputed Specifics not disclosed Specifics not disclosed 1 year
Fosterb 2010 caloric restriction in low fat group BMI = 30–40 Weight Random number generator ITT reported (sensitivity analysis with completer data not significantly different) Reasons listed Weight at Δ = 3% 2 years
Gardnera 2007 no caloric restriction in Atkins or Ornish women 25–50 yo, BMI = 27–40 Weight Blocked, disclosed via envelopes ITT (LOCF) reported (sensitivity analysis with completer data not significantly different) Reasons listed Weight at Δ = 2.7kg 1 year
Lean 1997 1200 kcal/day in each group BMI≥25 Weight Specifics not disclosed ITT (LOCF) reported; also set deltas = 0 where no f/u data available Specifics not disclosed Specifics not disclosed 6 months
Lima 2010 1548 kcal/day in each group BMI = 28–40 Weight & CV risk factors Stratified Modeled to use partial data, rather than ITT or LOCF Reasons listed Weight at Δ = 1kg 15 months
Meckling 2004 restriction in both LoFAT & LoCHO BMI>25 with dietary intake of >4000 kJ/d Weight, body comp & lipids Specifics not disclosed Appears to be completer results from text Specifics not disclosed Specifics not disclosed 10 weeks
Ruth 2013 500 kcal deficit target in each group BMI 29–45 Weight loss, with focus on adipose tissue inflammation Randomization blocked Completers reported Reasons listed Specifics not disclosed 12 weeks
Trubya,b 2006 None BMI = 27–40 Weight and body fat Stratified For weight ITT (LOCF) with lipids reported for completers Reasons listed Weight at Δ = 4kg 6 months
Volek 2009 not instructed to reduce calories in either group (both did) BMI>25 Cardiovascular risk factors Specifics not disclosed All completed All completed Specifics not disclosed 12 weeks
Yancy 2004 LoFAT with caloric restriction BMI = 30–60 & abnormal lipids Weight & lipids Computer generated Missing data imputed Reasons listed Specifics not disclosed 6 months