Table 1.
Summary of trial characteristics a.
| Trial Characteristics | Substitution Trials |
Addition Trials |
Subtraction Trials |
Ad Libitum Trials |
|---|---|---|---|---|
| Trial comparisons (n) | 35 | 39 | 4 | 2 |
| Participants (median n ((range)) | 29 (7–102) | 23 (6–91) | 12 (5–15) | 92 (92–92) |
| Health status (n trials) | NW = 5; MW = 7; OW/OB = 17; MetS = 1; NAFLD = 5 | NW = 9; MW = 9; OW/OB = 4; DM2 = 3; NAFLD = 1; Other = 5 | MW = 1; OW/OB = 3 | MW = 2 |
| Sex ratio (% male:female) b | 62:38 | 61:39 | 25:75 | 35:65 |
| Age (years; median (range)) b | 38 (7.7–59) | 36.2 (21.7–58.9) | 28.7 (28.3–29.1) | 29 (29–29) |
| Age category ratio (%; adult:children:mixed) b | 86:14:0 | 100:0:0 | 100:0:0 | 100:0:0 |
| Country (n trials) | 1 Brazil; 1 Denmark; 5 Finland; 2 Germany; 1 Greece; 2 Iran; 1 Sweden; 4 Switzerland; 7 UK; 8 USA; 1 Netherlands | 1 China; 8 Denmark; 1 Germany; 2 Iran; 4 Malaysia; 2 Netherlands; 1 Pakistan; 1 Sweden; 8 Switzerland; 1 UK; 2 USA | 2 Switzerland; 2 USA | 2 Finland |
| Setting ratio (%; inpatients:outpatients:inpatients/outpatients) | 9:88:3 | 8:87:5 | 50:50:0 | 0:100:0 |
| Baseline IHCL (% liver fat; median (range)) c | 5.7 (2.6–16.5) | 4.1 (1.6–9.7) | 2.9 (2.6–3.3) | NR |
| Baseline ALT (U/L; median (range)) d | 23 (5.2–116.6) | 25 (16.4–46.9) | 28.5 (21.6–39.7) | NR |
| Baseline AST (U/L; median (range)) e | 25 (7.9–68.8) | 26 (18–37) | 24.7 (21.6–27.9) | NR |
| Trial design ratio (%; crossover:parallel) | 37:62 | 56:44 | 50:50 | 0:100 |
| Feeding control ratio (%; met:sup:DA:met/sup) | 22:66:11:3 | 5:87:0:8 | 50:50:0:0 | 0:100:0:0 |
| Randomization ratio (%; yes:no:partial) f | 91:9:0 | 85:15:0 | 50:50:0 | 0:0:100 |
| Fructose-containing sugar dose (% of total energy intake; median (range)) | 20 (1–42) | 12.2 (1.2–35) | 16.3 (15–22.5) | 14.4 (14–14.7) |
| Follow-up duration (median n (range) of weeks) | 4 (1–52) | 1 (1–24) | 7 (1.7–12) | 88 (88–88) |
| Funding sources (%; A:I:A+I:NR) | 54:40:0:6 | 69:3:26:3 | 50:0:50:0 | 0:0:0:100 |
| Fructose-containing sugar type (n trials) | Fructose = 11; fruit = 8; HFCS = 2; sucrose = 14 | Fructose = 13; sucrose = 7; honey = 5; HFCS = 1; fruit = 13 | Sucrose = 4 | Fructose = 1; sucrose = 1 |
| Sugar regulatory designation (n trials) | Naturally occurring = 7; added = 18; mixed = 10 | Naturally occurring = 13; added = 26 | Added = 2; mixed = 2 | Mixed = 2 |
| Comparator (n trials) | NNS = 1; fat = 8; glucose = 12; lactose = 2; starch = 5; mixed comparator = 9 | NNS = 6; diet alone = 22; fat = 1; water = 3; other = 7 | NNS = 4 | NNS = 2 |
| Food sources of fructose-containing sugars (n trials) | SSB = 13; sweetened dairy alternative (soy) = 1; 100% fruit juice = 2; fruit = 2; dried fruit = 3; honey = 1; sweets and desserts = 3; mixed sources (with SSBs) = 10 | SSB = 20; 100% fruit juice = 7; fruit = 4; dried fruit = 2; honey = 5; sweets and desserts = 1 | SSB = 2; mixed sources (with SSBs) = 2 | Mixed sources (with SSBs) = 2 |
A = agency; A+I = agency and industry; ALT = alanine aminotransferase; AST = aspartate aminotransferase; Pre-CVD = pre-cardiovascular disease; DA = dietary advice; DM2 = type-2 diabetes mellitus; HIV = human immunodeficiency virus; I = industry; IHCL = intrahepatocellular lipid; met = metabolically controlled; MetS = metabolic syndrome; MW = mixed weight; NAFLD = non-alcoholic fatty liver disease; No = number; NR = not reported; NW = normal weight; OB = obese; ODM2 = overweight or obese type-2 diabetes mellitus; OW = overweight; SSBs = sugar-sweetened beverages; sup = supplemented; UK = United Kingdom; USA = United States of America. a Values are rounded to nearest whole number except for baseline NAFLD outcomes. b Based on trials which report data. c Based on trial comparisons that reported baseline data (n = 21 trials missing baseline IHCL substitution trials and n = 20 trials missing baseline IHCL addition trials). Baseline % liver fat was calculated by multiplying the baseline standardized mean difference of IHCL and baseline standard deviation of all trial comparisons that reported % liver fat. d Based on trial comparisons that reported baseline data (n = 9 trials missing baseline ALT substitution trials; n = 14 trials missing for baseline ALT addition trials; and n = 2 trials missing for baseline ALT ad libitum trials). e Based on trial comparisons that reported baseline data (n = 13 trials missing baseline AST substitution trials; n = 19 trials missing baseline AST addition trials; and n = 2 trials missing for baseline ALT ad libitum trials). f Partial randomization was assigned to a trial comparison which randomized only selected participants.