Table 1.
Trial Characteristics | LDL-C | Non-HDL-C | apoB | HDL-C | TG |
---|---|---|---|---|---|
Trial comparisons (n) | 11 | 11 | 1 | 11 | 14 |
Study size, median (range) a | 37 (24–45) | 37 (24–45) | 38 | 37 (24–45) | 35 (14–45) |
Age (y), median (range) | 55 (42–64) | 55 (42–64) | 57 (54–60) | 55 (42–64) | 54 (42–64) |
Health status (n) | Absence of disease = 2, T2D = 1, Hypercholesterolemia = 8 | Absence of disease = 2, T2D = 1, Hypercholesterolemia = 8 | Hypercholesterolemia = 1 | Absence of disease = 2, T2D = 1, Hypercholesterolemia = 8 | Absence of disease = 5, T2D = 1, Hypercholesterolemia = 8 |
Male:female ratio (%) b | 44:59 | 44:59 | 16:84 | 44:59 | 45:58 |
Country (No. of comparisons) | Australia = 1, Brazil = 1, Canada = 1, Germany = 4, Italy = 4, USA = 1 | Australia = 1, Brazil = 1, Canada = 1, Germany = 4, Italy = 4, USA = 1 | Brazil = 1 | Australia = 1, Brazil = 1, Canada = 1, Germany = 4, Italy = 4, USA = 1 | Australia = 1, Brazil = 1, Canada = 4, Germany = 4, Italy = 4, USA = 4 |
Study design (%), crossover:parallel | 36:64 | 36:64 | 100:0 | 36:64 | 29:71 |
Feeding control (%), met:sup:DA:met,sup | 0:100:0:0 | 0:100:0:0 | 0:100:0:0 | 0:100:0:0 | 0:100:0:0 |
Lipid medication use ratio (%), yes:no:mixed:unclear | 0:82:0:8 | 0:82:0:18 | 0:100:0:0 | 0:82:0:18 | 0:86:0:14 |
Settings (%), inpatients:outpatients:inpatient,outpatient | 0:100:0 | 0:100:0 | 0:100:0 | 0:100:0 | 0:100:0 |
Baseline BW (kg), median (range) c | 77.4 (66.7–89.5) | 77.4 (66.7–89.5) | 66.7 (62.2–71.2) | 77.4 (66.7–89.5) | 81.1 (66.7–89.5) |
Baseline BMI (kg/m2), median (range) | 26.0 (24.7–30.6) | 26.0 (24.7–30.6) | 27.3 (26.1–28.5) | 26.0 (24.7–30.6) | 27.3 (24.7–31.5) |
Baseline outcome d, median (range) | 4.1 (3.1–4.9) | 4.9 (3.6–5.6) | 1.3 (1.3–1.4) | 1.5 (1.1–1.7) | 1.5 (1.1–1.8) |
Follow-up duration (week), median (range) | 4 (4–8) | 4 (4–8) | 6 | 4 (4–8) | 4 (4–8) |
Pulse protein dose (g/day), median (range) | 35 (5–122) | 35 (5–122) | 25 | 35 (5–122) | 30 (1–122) |
Intervention and food source (%), extracted and make into a food:beverage:food & beverage:tablet | 73:9:9:9 | 73:9:9:9 | 0:100:0:0 | 73:9:9:9 | 57:7:7:29 |
Comparator (No. of comparisons) | Animal protein = 2; Casein, milk protein = 9 | Animal protein = 2; Casein, milk protein = 9 | Casein, milk protein = 1 | Animal protein = 2; Casein, milk protein = 9 | Animal protein = 2; Casein, milk protein = 12 |
Energy balance (%), neutral:positive:negative e | 91:9:0 | 91:9:0 | 100:0:0 | 91:9:0 | 71:29:0 |
Energy control (%), substitution:addition:subtraction f | 100:0:0 | 100:0:0 | 100:0:0 | 100:0:0 | 100:0:0 |
Funding sources (%), A:I:A,I:NR g | 64:27:9 | 64:27:9 | 0:100:0:0 | 64:27:9 | 50:21:29 |
A, agency; apoB, apolipoprotein B; BMI, body mass index; BW, body weight; DA, dietary advice; HDL-C, high-density lipoprotein cholesterol; I, industry; LDL-C, low-density lipoprotein cholesterol; met, metabolic; NR, not reported; non-HDL-C, non-high-density lipoprotein cholesterol; sup, supplement; T2D, type 2 diabetes; TG, triglyceride. * All numbers with the exception of baseline values were rounded to the nearest whole number to improve readability. a All sample sizes reflect participants included in the data analyzed. b Not all studies reported females and males analyzed. Sitori et al. (2012) [56] reported the number of females and males recruited. c Not all trials reported baseline values. Baseline values were not reported for baseline BW (n = 5). d units for LDL-C, non-HDL-C, HDL-C, and TG are in mmol/L and for apoB, g/L. e Neutral energy balance refers to the maintenance of usual energy intake. A positive energy balance refers to a greater-than-normal energy intake. A negative energy balance refers to a deficit in normal energy intake. f Energy control refers to the energy intake of the intervention group compared to the control group where substitution refers to energy matched between intervention and comparator, addition refers to excess energy between the intervention and the comparator, and subtraction refers to a deficit in energy between the intervention and the comparator. g Agency funding is from government, university, or not-for-profit sources. The majority of industry funding is from trade organizations that obtain revenue from the sale of products.