Table 2.
Design and subject characteristics of randomized controlled studies of plant sterols/stanols.
| Study ID | Reference | Design | Duration weeks | n | Subjects1 | Sex2 | Age years | BMI3 kg/m2 |
|---|---|---|---|---|---|---|---|---|
| AbuMweis et al. (2006a) | (32) | Crossover | 4 | 30 | Borderline high | NR | 59 | 25–29.9 |
| AbuMweis et al. (2006b) | (32) | Crossover | 4 | 30 | Borderline high | NR | 59 | 25–29.9 |
| Algorta Pineda et al. 2005 | (34) | Parallel | 3 | 32 | High | 50–95% males | 42 | 25–29.9 |
| Alhassan et al. 2006 | (60) | Parallel | 5 | 26 | Near or above optimal | 5–50% males | 53Tx 52Co | 25–29.9 |
| Andersson et al. 1999 | (13) | Parallel | 8 | 40 | High | 5–50% males | 55 | 25–29.9 |
| Ayesh et al. 1999 | (61) | Parallel | 3 & 4 | 21 | Optimal | 5–50% males | 36 | <24.9 |
| Cater et al. (2005a) | (62) | Crossover | 6 | 8 | NR | 50–95% males | 58 | 25–29.9 |
| Cater et al. (2005b) | (62) | Crossover | 6 | 8 | NR | 50–95% males | 58 | 25–29.9 |
| Cater et al. (2005c) | (62) | Crossover | 6 | 8 | NR | 50–95% males | 58 | 25–29.9 |
| Cater et al. (2005d) | (62) | Crossover | 8 | 10 | Near or above optimal | >95% males | 66 | 25–29.9 |
| Christiansen et al. (2001a) | (63) | Parallel | 26 | 92 | High | NR | 51 | <24.9 |
| Christiansen et al. (2001b) | (63) | Parallel | 26 | 89 | High | NR | 51 | 25–29.9 |
| Cleghorn et al. 2003 | (64) | Crossover | 4 | 50 | Borderline high | 5–50% males | 47 | 25–29.9 |
| Davidson et al. (2001a) | (28) | Parallel | 8 | 42 | Borderline high | 50–95% males; | 46 | NR |
| Davidson et al. (2001b) | (28) | Parallel | 8 | 40 | Borderline high | 50–95% males; | 46 | NR |
| Davidson et al. (2001c) | (28) | Parallel | 8 | 44 | Borderline high | 50–95% males; | 46 | NR |
| De Graaf et al. 2002 | (47) | Parallel | 4 | 62 | High | 50–95% males; | 56 Tx 58 Co | 25–29.9 |
| Deavarj et al. 2006 | (22) | Parallel | 8 | 72 | Borderline high | 5–50% males | 44 Tx 48 Co | <24.9 |
| Devaraj et al. (2004) | (23) | Parallel | 8 | 72 | borderline high | 5–50% males | 41 Tx 44 Co | 25–29.9 |
| Doornbos et al. (2006a) | (19) | Parallel | 4 | 72 | Borderline high | 5–50% males | 57 | 25–29.9 |
| Doornbos et al. (2006b) | (19) | Parallel | 4 | 71 | Borderline high | 5–50% males | 57 | 25–29.9 |
| Doornbos et al. (2006c) | (19) | Parallel | 4 | 69 | Borderline high | 5–50% males | 57 | 25–29.9 |
| Doornbos et al. (2006d) | (19) | Parallel | 4 | 71 | Borderline high | 5–50% males | 57 | 25–29.9 |
| Gylling et al. (1994) | (65) | Crossover | 6 | 11 | NR | >95% males | 58 | 25–29.9 |
| Gylling et al. 1999 | (66) | Crossover | 5 | 21 | Borderline high | <5% males | 53 | 25–29.9 |
| Hallikainen et al. (1999a) | (10) | Parallel | 8 | 37 | High | 5–50% males | 41 Tx 46 Co | <24.9 Tx 25–29.9 Co |
| Hallikainen et al. (1999b) | (10) | Parallel | 8 | 35 | High | 5–50% males | 43 Tx 46 Co | 25–29.9 |
| Hallikainen et al. (2000a) | (67) | Crossover | 4 | 34 | High | NR | 49 | <24.9 |
| Hallikainen et al. (2000b) | (67) | Crossover | 4 | 34 | High | NR | 49 | <24.9 |
| Hendriks et al. (1999a) | (12) | Crossover | 3.5 | 80 | Near or above optimal | 5–50% males | 37 | <24.9 |
| Hendriks et al. (1999b) | (12) | Crossover | 3.5 | 80 | Near or above optimal | 5–50% males | 37 | <24.9 |
| Hendriks et al. (1999c) | (12) | Crossover | 3.5 | 80 | Near or above optimal | 5–50% males | 37 | <24.9 |
| Hendriks et al. 2003 | (68) | Parallel | 52 | 185 | Borderline high | 5–50% males | 48 | <24.9 |
| Hyun et al. 2005 | (18) | Parallel | 4 | 51 | Near or above optimal | 50–95% males; | 29 | <24.9 |
| Jakulj et al. 2005 | (69) | Crossover | 4 | 39 | Very high | 50–95% males; | 56 | 25–29.9 |
| Jones et al. 1999 | (54) | Parallel | 4.3 | 32 | High & very high | >95% males | NR | NR |
| Jones et al. (2000a) | (50) | Crossover | 3 | 15 | High | >95% males | NR | NR |
| Jones et al. (2000b) | (50) | Crossover | 3 | 15 | High | >95% males | NR | NR |
| Jones et al. (2003a) | (27) | Crossover | 3 | 15 | Borderline high | 50–95% males | NR | NR |
| Jones et al. (2003b) | (27) | Crossover | 3 | 15 | Borderline high | 50–95% males | NR | NR |
| Judd et al. 2002 | (70) | Crossover | 3 | 53 | Borderline high | 5–50% males | 47 | 25–29.9 |
| Jauhianen et al. 2006 | (49) | Parallel | 5 | 67 | Borderline high | 5–50% males | 43 | NR |
| Lau et al. (2005a) | (71) | Crossover | 3 | 15 | Borderline high | 5–50% males | 55 | 25–29.9 |
| Lau et al. (2005b) | (71) | Crossover | 3 | 14 | Borderline high | 5–50% males | 55 | 30–34.9 |
| Lee et al. 2003 | (72) | Parallel | 12 | 81 | High | 5–50% males | 60 TX 62 Co | 25–29.9 |
| Lottenberg et al. 2003 | (73) | Crossover | 4 | 60 | Very high | 5–50% males | NR | NR |
| Maki et al. (2001a) | (37) | Parallel | 5 | 158 | Borderline high | 5–50% males | 59 Tx 58 Co | 25–29.9 |
| Maki et al. (2001b) | (37) | Parallel | 5 | 118 | Borderline high | 5–50% males | 60 Tx 58 Co | 25–29.9 |
| Matvienko et al. (2002) | (33) | Parallel | 4 | 34 | Borderline high | >95% males | 22 Tx 22 Co | 25–29.9 |
| Mensink et al. (2002) | (20) | Parallel | 4 | 60 | Near or above optimal | 5–50% males | 36 | <24.9 |
| Miettinen and Vanhanen (1994a) | (45) | Parallel | 9 | 17 | NR | 50–95% males | 45 | 25–29.9 |
| Miettinen and Vanhanen (1994b) | (45) | Parallel | 9 | 15 | NR | 50–95% males | 45 | 25–29.9 |
| Miettinen and Vanhanen (1994c) | (45) | Parallel | 9 | 15 | NR | 50–95% males | 45 | 25–29.9 |
| Mussner et al. (2002) | (35) | Crossover | 3 | 63 | Borderline high | 5–50% males | 42 | <24.9 |
| Naumann et al. (2003a) | (36) | Crossover | 3 | 42 | Near or above optimal | 5–50% males | 32 w 37 m | <24.9 |
| Crossover | ||||||||
| Naumann et al. (2003b) | (36) | Crossover | 3 | 42 | Near or above optimal | 5–50% males | 32 w 37 m | <24.9 |
| Neil et al. 2001 | (74) | Crossover | 8 | 29 | Very high | 5–50% males | 53 Tx 50 Co | 25–29.9 |
| Nguyen et al. (1999a) | (75) | Parallel | 8 | 159 | Borderline high | 5–50% males | 53 | 25–29.9 |
| Nguyen et al. (1999b) | (75) | Parallel | 8 | 157 | Borderline high | 5–50% males | 53 | 25–29.9 |
| Nguyen et al. (1999c) | (75) | Parallel | 8 | 162 | Borderline high | 5–50% males | 53 | 25–29.9 |
| Nigon et al. 2001 | (76) | Crossover | 8 | 53 | Borderline high & high | 5–50% males | 58 | <24.9 |
| Noakes et al. (2002a) | (77) | Crossover | 3 | 46 | High | 5–50% males | 58 w 55 m | 25–29.9 |
| Noakes et al. (2002b) | (77) | Crossover | 3 | 46 | High | 5–50% males | 58 w 55 m | 25–29.9 |
| Noakes et al. (2002c) | (77) | Crossover | 3 | 35 | High | 50–95% males | 56 w 58 m | 25–29.9 |
| Noakes et al. (2005a) | (16) | Crossover | 3 | 40 | High | 5–50% males | 60 | 25–29.9 |
| Noakes et al. (2005b) | (16) | Crossover | 3 | 40 | High | 5–50% males | 60 | 25–29.9 |
| Ntanios et al. 2002 | (38) | Crossover | 3 | 53 | Near or above optimal | 5–50% males | 45 | <24.9 |
| Plat and Mensink et al. (2000a) | (78) | Parallel | 8 | 78 | Near or above optimal | 5–50% males | 33 | <24.9 |
| Plat and Mensink et al. (2000b) | (78) | Parallel | 8 | 76 | Near or above optimal | 5–50% males | 33 | <24.9 |
| Plat et al. (2000a) | (31) | Crossover | 4 | 39 | Optimal | 5–50% males | 31 | <24.9 |
| Plat et al. (2000b) | (31) | Crossover | 4 | 39 | Optimal | 5–50% males | 31 | <24.9 |
| Polagruto et al. 2006 | (48) | Parallel | 6 | 67 | High | 5–50% males | 49 Tx 56 Co | 25–29.9 |
| Quilez et al. 2003 | (21) | Parallel | 8 | 57 | Optimal | 5–50% males | 31 | <24.9 |
| Saito et al. (2006a) | (79) | Parallel | 4 | 33 | Borderline high | >95% males | 38 Tx 39 Co | <24.9 |
| Saito et al. (2006b) | (79) | Parallel | 4 | 33 | Borderline high | >95% males | 39 | <24.9 |
| Saito et al. (2006c) | (79) | Parallel | 4 | 34 | Borderline high | >95% males | 38 Tx 39 Co | <24.9 |
| Seki et al. (2003) | (43) | Parallel | 12 | 60 | Borderline high | >95% males | 39 | <24.9 |
| Sierksma et al. 1999 | (80) | Crossover | 3 | 75 | NR | 50–95% males | 44 | <24.9 |
| Simons et al. 2002 | (42) | Parallel | 4 | 77 | Very high | 50–95% males | 58 Tx 60 Co | 25–29.9 |
| Spilburg et al. 2003 | (26) | Parallel | 4 | 24 | Borderline high | 50–95% males | 51 | 25–29.9 |
| Temme et al. 2002 | (81) | Crossover | 4 | 42 | High | 50–95% males | 55 | 25–29.9 |
| Thomsen et al. (2004a) | (15) | Crossover | 4 | 69 | High | 5–50% males | 60 | 25–29.9 |
| Thomsen et al. (2004b) | (15) | Crossover | 4 | 69 | High | 5–50% males | 60 | 25–29.9 |
| Vanhanen et al. 1993 | (82) | Parallel | 6 | 67 | Borderline high | 50–95% males | 48 Tx 43 Co | 25–29.9 |
| Vanhanen et al. 1994 | (83) | Parallel | 6 | 14 | Borderline high | 5–50% males | 55 | 25–29.9 |
| Vanstone et al. (2002a) | (51) | Crossover | 3 | 15 | High | 50–95% males | 48 | 30–34.9 |
| Vanstone et al. (2002b) | (51) | Crossover | 3 | 15 | High | 50–95% males | 48 | 30–34.9 |
| Vanstone et al. (2002c) | (51) | Crossover | 3 | 15 | High | 50–95% males | 48 | 30–34.9 |
| Vissers et al. 2000 | (84) | Crossover | 3 | 60 | NR | 5–50% males | NR | NR |
| Volpe et al. 2001 | (17) | Crossover | 4 | 30 | High | 50–95% males | NR | <24.9 |
| Weststrate et al. (1998a) | (8) | Crossover | 3.5 | 95 | Borderline high | 50% males | 45 | <24.9 |
| Weststrate et al. (1998b) | (8) | Crossover | 3.5 | 95 | Borderline high | 50% males | 45 | < 24.9 |
| Yoshida et al. (2006a) | (24) | Crossover | 3 | 16 | High | 5–50% males | 55 | 25–29.9 |
| Yoshida et al. (2006b) | (24) | Crossover | 3 | 13 | Borderline high | 5–50% males | 57 | 30–34.9 |
NR = not reported, NC = Not clear, Tx = treatment; Co = control; w = women; m = men.
1Subjects were classified according to total or cholesterol baseline levels reported in baseline characteristic. Classification based on ATPIII (85).
2Predominant sex.
3Body Mass Index.