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. 2018 Apr 2;8(3):e019438. doi: 10.1136/bmjopen-2017-019438

Table 1.

Summary of trial characteristics

Trial characteristics* All Neutral energy balance Negative energy balance
Trial no (n) 32 23 9
Trial size (total, range) 2448 (8–250) 1989 (8–250) 459 (13–123)
Male:female† (%) 40:60 47:53 27:73
Age (years) 50 (40–58) 52.0 (42.1–59.5) 49.5 (34.2–53.0)
Metabolic phenotype (OW/OB:DM:CHD) (%) 66:31:3 57:39:4 89:11:0
Setting (IP:OP) (%) 3:97 4:96 0:100
Baseline body weight (kg)‡ 85.5 (80.0–91.9) 84.1 (79.5–87.5) 92.5 (86.1–93.9)
Baseline BMI (kg/m2 30.4 (28.2–32.0) 29.5 (27.4–31.4) 31.7 (30.1–32.9)
Study design (C:P) (%) 19:81 26:74 0:100
Dose pasta (servings/week)¶ 3.3 (2.3–3.5) 3.4 (2.9–4.1) 2.3 (2.3–3.5)
GI in pasta/LGI group 49.0 (44.0–55.1) 46.5 (49.9–55.5) 44.0 (42.3–49.4)
GI in higher-GI group 62.5 (61.6–63.2) 63.3 (60.1–64.4) 61.0 (59.2–66.6)
Calorie reduction in pasta/LGI group (kcal)** −179 (−90 to −448) −165 (−74 to −313) −447 (−134 to −594)
Calorie reduction in higher-GI group (kcal)** −181 (−93 to −401) −160 (−40 to −248) −470 (−172 to −561)
Feeding control (Met:Suppl:DA) (%) 6:44:50 4:48:48 11:33:56
Follow-up duration (weeks) 12 (9–21) 12 (6–24) 12 (10–21)
Funding sources
(A:I:AI:NR) (%)
47:9:25:19 44:13:26:17 56:0:22:22

*Median (IQR), unless otherwise indicated.

†24/32 trials provided data on sex.

‡30/32 trials reported baseline body weight.

§28/32 trials reported baseline BMI.

¶11/32 trials provided data from which dose could be approximated.

**20/32 trials provided data from which to approximate changes in caloric intake.

A, agency; AI, agency and industry; BMI, body mass index; C, cross-over design; CHD, coronary heart disease; DA, dietary advice; DM, diabetes; GI, glycaemic index; I, industry; IP, inpatient; LGI, low glycaemic index; Met, metabolic; NR, not reported; OB, obese; OP, outpatient; OW, overweight; P, parallel design; Suppl, supplemented/provision of certain food.