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Table 1 Baseline characteristics according to the treatment which subjects were randomized to receive during the first 10-week period of the crossover trial*

From: Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial

Characteristic Melatonin first Placebo first
N 19 20
Age, years (mean, SD) 62.7 ± 9.6 57.6 ± 10.1
Sex (N, %)   
 Male 9 (52.6%) 8 (40.0%)
 Female 10 (47.4%) 12 (60.0%)
Race (N, %)   
 White 13 (68.4%) 11 (55.0%)
 African-American 6 (31.6%) 7 (35.0%)
 Asian 0 (0.0%) 1 (5.0%)
 Hispanic/Latino 0 (0.0%) 1 (5.0%)
Waist circumference, cm (mean, SD)   
 Male 114.1 ± 11.1 110.4 ± 5.3
 Female 102.6 ± 8.8 104.7 ± 11.4
Height, meters (mean, SD) 1.67 ± 0.11 1.70 ± 0.12
Weight, kg (mean, SD) 97.5 ± 19.4 98.1 ± 14.3
Body mass index (mean, SD) 35.2 ± 7.0 34.1 ± 6.4
HDL-cholesterol, mg/dL (mean, SD)   
 Male 37.7 ± 6.7 35.7 ± 6.3
 Female 44.7 ± 6.7 48.5 ± 12.5
LDL-cholesterol, mg/dL (mean, SD) 115.2 ± 33.6 115.9 ± 34.1
Triglycerides, mg/dL (mean, SD) 152.0 ± 59.3 210.1 ± 227.5
Fasting glucose, mg/dL (mean, SD) 102.2 ± 14.7 103.0 ± 13.3
SBP average clinic value, mmHg (mean, SD) 125.7 ± 14.5 126.5 ± 19.4
DBP average clinic value, mmHg (mean, SD) 76.5 ± 10.9 77.7 ± 12.0
Ambulatory blood pressure readings (mmHg)   
Full 24-hour period   
 Measurements per subject (mean, SD) 22.7 ± 2.7 22.4 ± 2.6
 Average SBP, mmHg (mean, SD) 126.4 ± 9.6 132.4 ± 9.3
 Average DBP, mmHg (mean, SD) 74.2 ± 9.6 77.5 ± 9.0
Wake period (0800 to 2200)   
Measurements per subject (mean, SD) 13.4 ± 2.4 13.2 ± 1.8
Average SBP, mmHg (mean, SD) 131.3 ± 10.1 135.5 ± 9.8
Average DBP, mmHg (mean, SD) 78.3 ± 7.4 80.7 ± 9.3
Sleep period (2200 to 0800)   
 Measurements per subject (mean, SD) 9.3 ± 1.0 9.2 ± 1.6
 Average SBP, mmHg (mean, SD) 119.9 ± 9.7 127.5 ± 10.9
 Average DBP, mmHg (mean, SD) 69.1 ± 7.1 72.5 ± 9.5
Subjects with each of the following MetS components (N, %)   
 Waist circumference ≥102 cm (male) or ≥88 cm (female) 19 (100.0%) 19 (95.0%)
 HDL cholesterol <40 mg/dL (male) or <50 mg/dL (female) 14 (73.7%) 17 (85.0%)
 Triglycerides ≥150 mg/dL 11 (57.9%) 11 (55.0%)
 Fasting glucose ≥100 mg/dL 14 (73.7%) 13 (65.0%)
 SBP ≥130 mmHg or DBP ≥85 mmHg 12 (63.2%) 16 (80.0%)
Number of MetS components per subject (mean, SD) 3.68 ± 0.67 3.80 ± 0.95
Proportion of subjects with MetS at the time of randomization (N, %) 11 (57.9%) 14 (70.0%)
Proportion with different number of components of MetS (N, %)   
 0 0 (0.0%) 0 (0.0%)
 1 2 (10.5%) 1 (5.0%)
 2 6 (31.6%) 5 (25.0%)
 3 7 (36.8%) 10 (50.0%)
 4 4 (21.1%) 2 (10.0%)
 5 0 (0.0%) 2 (10.0%)
  1. *P values are not presented comparing melatonin with placebo for baseline characteristics, because this is a crossover trial (and not a parallel group trial), in which all 39 subjects received both melatonin and placebo (or placebo and melatonin) in sequential order, and therefore each subject serves as his or her own control.