| Study | Participants | Interventions | Outcomes |
|---|---|---|---|
| Alekel 2000 | Participants: peri-men (com) | Design: parallel | DO: 11, unclear from which arms |
| USA (Alekel et al., 2000; Dent et al., 2001; St Germain et al., 2001; Swain et al., 2002; Moeller et al., 2003) | Analyzed: int 24, cont A 21, cont B 24 | Intervention:A: ISP versus milk protein | Duration: 24 weeks |
| Med age: int 50, cont A 49, cont B 51 | B: ISP versus alcohol-washed ISP | ||
| Isoflav, mg/day: int 80, cont A unclear, cont B 4.4 (AU) | |||
| Soy protein difference: 0 g/day | |||
| Arjmandi 2003 | Participants: post-men (com) | Design: parallel | DO: int 16, cont 13 |
| USA (Arjmandi et al., 2003, 2004) | Analyzed: int 20, cont 22 | Intervention: ISP versus milk protein | Duration: 12 weeks |
| Mean age: int 62, cont 62 | Isoflav, mg/day: int 88.4, cont 0 (AU) | ||
| Soy protein difference: 37 g/day | |||
| Arjmandi 2005 | Participants: post-men (com) | Design: parallel | DO: int 13, cont 12 |
| USA (Arjmandi et al., 2005) | Analyzed: int 35, cont 27 | Intervention: ISP versus no soy | Duration: 52 weeks |
| Mean age: int 53, cont 56 | Isoflav, mg/day: int 60, cont unclear (AU?) | ||
| Soy protein difference: 25 g/day | |||
| Aubertin-Leheudre 2007 | Participants: obese post-men (com) | Design: parallel | DO: 14 in each arm |
| Canada (Aubertin-Leheudre et al., 2007) | Analyzed: int 10, cont 10 | Intervention: isoflav ext versus placebo | Duration: 52 weeks |
| Mean age, sd: 58 overall | Isoflav, mg/day: int 70, cont unclear (AU?) | ||
| Soy protein difference: 0 g/day | |||
| Baird 1995 | Participants: post-men (com) | Design: parallel | DO: 6 (unclear from which arms) |
| USA (Baird et al., 1995) | Analyzed: int 66, cont 25 | Intervention: whole soy versus usual diet | Duration: 4 weeks |
| Mean age: unclear | Isoflav, mg/day: int 165, cont unclear (AU?) | ||
| Soy protein difference: unclear | |||
| Baum 1998 | Participants: HC post-men (com) | Design: parallel | DO: 15 (unclear from which arms) |
| USA (Baum et al., 1998; Persky et al., 2002; Potter et al., 1998) | Analyzed: ISP90 21, ISP56 23, cont 22 | Intervention: ISP versus milk protein | Duration: 24 weeks |
| Mean age: ISP90 61, ISP56 60, cont 61 | Isoflav, mg/day: ISP90 90, ISP56 56, cont nil (AU) | ||
| Soy protein difference: 37 g/day | |||
| Brink 2008 (NL, Italy, France) | Participants: post-men (com) | Design: parallel | DO: int NL 5, It 13, Fr 14, cont NL 5, It 11, Fr 15 |
| Netherlands, Italy, France (Brink et al., 2008) | Analyzed:NL int 45, cont 46; It int 39, cont 39; Fr int 34, cont 34 | Intervention: isoflav ext versus nil | Duration: 52 weeks |
| Mean age:NL int 53, cont 53; It int 53, cont 53; Fr int 54, cont 54 | Isoflav, mg/day: int 110, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Brooks 2004 | Participants: post-men (com) | Design: parallel | DO: int 2, cont 0 |
| Canada (Lewis et al., 2006; Brooks et al., 2004) | Analyzed: int 13, cont 15 | Intervention: soy foods versus wheat flour | Duration: 16 weeks |
| Mean age: int 54, cont 53 | Isoflav, mg/day: int 41.4, cont unclear (AU?) | ||
| Soy protein difference: 8 g/day | |||
| Brown 2002 | Participants: pre-men (com) | Design: crossover | DO: 12 |
| USA (Brown et al., 2002) | Analyzed: 14 | Intervention ISP versus alternate foods | Duration: 2 cycles |
| Mean age: 28 | Isoflav, mg/day: int 40, cont none (AU?) | ||
| Soy protein difference: 31 g/day | |||
| Cassidy 1995 | Participants: pre-men (metabolic unit) | Design: crossover | DO: 3 drop outs from study 2 |
| UK (Cassidy et al., 1994, 1995) | Analyzed: Study 1: 6, Study 2: 6, Study 3: 5, Study 4: 6 | Intervention: soy foods versus nil | Duration: 1 cycle |
| Mean age: Study 1: 24, Studies 2–4: unclear | Isoflav, mg/day: Study 1: int 45, cont 1; Study 2: int 25, cont unclear; Study 3: unclear; Study 4: int 23, cont unclear (AU—No) | ||
| Soy protein difference: Study 1 30 g/day; Study 2 7 g/day; Study 3 unclear; Study 4 14 g/day | |||
| Cheng 2007 | Participants: post-men (com) | Design: parallel | DO: 9 (unclear from which arms) |
| Sweden (Cheng et al., 2007) | Analyzed: int 26, cont 24 | Intervention: isoflav ext versus oatmeal | Duration: 12 weeks |
| Mean age: int 58, cont 56 | Isoflav, mg/day: int 60, cont unclear (AU?) | ||
| Soy protein difference: 0 g/day | |||
| Cuevas 2003 | Participants: raised LDL post-men (com) | Design: crossover | DO: unclear |
| Chile (Cuevas et al., 2003) | Analyzed: 18 | Intervention: ISP versus milk protein | Duration: 4 weeks |
| Mean age: 59 | Isoflav, mg/day: int 80, cont unclear (AU?) | ||
| Soy protein difference: 37 g/day | |||
| D’Anna 2007 | Participants: post-men (com) | Design: parallel | DO: 48 int, 37 cont at 2 years |
| Italy (D’Anna et al., 2005; Atteritano et al., 2007; Marini et al., 2007) | Analyzed: int 150, cont 154 | Intervention: isoflav ext versus placebo | Duration: 104 weeks |
| Mean age, sd: int 55, cont 54 | Isoflav, mg/day: int 54, cont nil (AU) | ||
| Soy protein difference: 0 g/day | |||
| Dewell 2002 | Participants: HC post-men (com) | Design: parallel | DO: 4 (unclear from which arms) |
| USA (Dewell et al., 2002; Bruce et al., 2003) | Analyzed: int 22, cont 16 | Intervention: isoflav ext versus placebo | Duration: 26 weeks |
| Mean age: int 69, cont 70 | Isoflav, mg/day: int 90 AU, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Duncan 1999 Pre | Participants: pre-men (com) | Design: crossover | DO: 6 |
| USA (Xu et al., 1998; Duncan et al., 1999a; Merz-Demlow et al., 2000; Wangen et al., 2000; Phipps et al., 2001; Fritz et al., 2003) | Analyzed: 14 | Intervention: ISP versus low isoflavone ISP | Duration: 13 weeks |
| Mean age: 27 | Isoflav, mg/day: highISO 128.7, medISO 64.7, Cont 10.0 (AU) | ||
| Soy protein difference: 0 g/day | |||
| Duncan 1999 Post | Participants: post-men (com) | Design: crossover | DO: 4 |
| USA (Duncan et al., 1999b; Xu et al., 2000; Phipps et al., 2001; Wangen et al., 2001) | Analyzed: 18 | Intervention: ISP versus low isoflavone ISP | Duration: 13 weeks |
| Mean age: 57 | Isoflav, mg/day: int 132, cont 7.1 (AU) | ||
| Soy protein difference: 0 g/day | |||
| Gann A 2005 | Participants: pre-men (com) | Design: parallel | DO: unclear |
| USA (Gann et al., 2005) | Analyzed: int 43, cont 43 | Intervention: ISP versus low isoflavone ISP | Duration: 3 cycles |
| Mean age: int 34, cont 33 | Isoflav, mg/day: int 84.4, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Gann B 2005 | Participants: pre-men (com) | Design: parallel | DO: unclear |
| USA (Gann et al., 2005) | Analyzed: int 38, cont 30 | Intervention: ISP versus low isoflavone ISP | Duration: 3 cycles |
| Mean age: int 34, cont 33 | Isoflav, mg/day: int 84.4, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Gardner 2001 | Participants: HC post-men (com) | Design: parallel | DO: int 3, cont A 2, cont B 1 |
| USA (Gardner et al., 2001) | Analyzed: int 31, cont A 30, cont B 33 | Intervention: ISP versus A milk protein, B low isoflavone ISP | Duration: 12 weeks |
| Mean age: int 63, cont A 58, cont B 58 | Isoflav, mg/day: int 80, contA 2, contB 3 (AU) | ||
| Soy protein difference: 0 or 39 g/day | |||
| Garrido 2006 | Participants: post-men (com) | Design: parallel | DO: none |
| Chile (Garrido et al., 2006) | Analyzed: int 15, cont 14 | Intervention: isoflav ext versus placebo | Duration: 12 weeks |
| Mean age: int 54, cont 53 | Isoflav, mg/day: int 100, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Han 2002 | Participants: post-men (com) | Design: parallel | DO: int 1, cont 1 |
| Brazil (Han et al., 2002) | Analyzed: int 40, cont 40 | Intervention: isoflav ext versus glucose | Duration: 16 weeks |
| Mean age: int 48, cont 49 | Isoflav, mg/day: int 100, cont nil (AU) | ||
| Soy protein difference: 0 g/day | |||
| Harkness 2004 | Participants: post-men (com) | Design: crossover | DO:1 |
| USA (Harkness et al., 2004) | Analyzed: 19 | Intervention: isoflav ext versus placebo | Duration: 26 weeks |
| Mean age: 71 | Isoflav, mg/day: int 110, cont unclear (AU - No) | ||
| Soy protein difference: 0 g/day | |||
| Huang 2006 | Participants: post-men (com) | Design: parallel | DO: 1 overall (unclear in which arm) |
| Taiwan (Huang et al., 2006) | Analyzed: int IF200 15, int IF100 15, cont 12 | Intervention: isoflav ext versus nil | Duration: 52 weeks |
| Mean age: IF200 int 52, IF100 int 54, cont 51 | Isoflav, mg/day: IF200 200, IF100 100, cont nil (AU?) | ||
| Soy protein difference: 0 g/day | |||
| Jayagopal 2002 | Participants: diabetic post-men (com) | Design: crossover | DO: 1 |
| UK (Jayagopal et al., 2002) | Analyzed: 32 | Intervention: ISP versus microcrystalline cellulose | Duration: 12 weeks |
| Mean age: 63 | Isoflav, mg/day: int 132, contl unclear (AU?) | ||
| Soy protein difference: 30 g/day | |||
| Knight 2001 | Participants: post-men (com) | Design: parallel | DO: int 3, cont 1 |
| Australia (Knight et al., 2001) | Analyzed: int 9, cont 11 | Intervention: ISP versus milk protein | Duration: 12 weeks |
| Mean age: int 52, cont 54 | Isoflav, mg/day: int 77.4, cont unclear (AU) | ||
| Soy protein difference: 55 g/day | |||
| Kotsopoulos 2000 (PEARL) | Participants: post-men (com) | Design: parallel | DO: int 20?, cont 35? |
| Australia (Kotsopoulos et al., 2000; Teede et al., 2001, 2004, 2005; Dalais et al., 2003) | Analyzed: int 30, cont 20 | Intervention: ISP versus milk protein | Duration: 12 weeks |
| Mean age: int 60, cont 60 | Isoflav, mg/day: int 118, cont unclear (AU?) | ||
| Soy protein difference: 40 g/day | |||
| Kumar 2002 | Participants: pre-men (com) | Design: parallel | DO: int 16, cont 15 |
| USA (Kumar et al., 2002) | Analyzed: int 33, cont 33 | Intervention: ISP versus milk protein | Duration: 3 cycles |
| Mean age: int 41, cont 43 | Isoflav, mg/day: int 40 genistein, cont 0 (AU?) | ||
| Soy protein difference: unclear | |||
| Lichtenstein 2002 | Participants: HC post-men (com, AFP) | Design: crossover | DO: 4 dropped out but were replaced |
| USA (Lichtenstein et al., 2002; Desroches et al., 2004; Wang et al., 2004; Goldin et al., 2005; Vega-Lopez et al., 2005) | Analyzed: 10 or 11 | Intervention: isoflav ext versus nil, also ISP versus low isoflavone ISP | Duration: 6 weeks |
| Mean age: 64 | Isoflav, mg/day: isoflav ext int 114, cont nil, ISP int 102, cont 3 (AU) | ||
| Soy protein difference: g/day | |||
| Mackey 2000 | Participants: HC post-men (com?) | Design: parallel | DO: 5 in total (unclear in which arms) |
| Australia (Eden et al., 2000; Mackey et al., 2000) | Analyzed: int 25, cont 24 | Intervention: ISP versus low isoflavone ISP | Duration: 12 weeks |
| Mean age: int 56, cont 57 | Isoflav, mg/day: int 65, cont <4 (AU?) | ||
| Soy protein difference: 0 g/day | |||
| Martini OC 1999 | Participants: pre-men (com) | Design: crossover | DO: 4 |
| USA (Rutman et al., 1997; Martini et al., 1999) | Analyzed: 16 | Intervention: ISP versus milk protein | Duration: 2 cycles |
| Mean age: 30 | Isoflav, mg/day: int 38, cont unclear (AU?) | ||
| Soy protein difference: 20 g/day | |||
| Maskarinec 2002 | Participants: pre-men (com) | Design: parallel | DO: 5 (unclear in which arms) |
| USA (Maskarinec et al., 2002a, b, 2003) | Analyzed: int 13, cont 16 | Intervention: isoflav ext versus maltodextrin | Duration: 52 weeks |
| Mean age: int 42, cont 43 | Isoflav, mg/day: int 76, cont 0 (AU) | ||
| Soy protein difference: 0 g/day | |||
| Maskarinec 2004 | Participants: pre-men (com) | Design: parallel | DO: 17 int, 14 cont |
| USA (Maskarinec et al., 2004, 2005) | Analyzed: int 92, cont 97 | Intervention: soy foods versus usual diet | Duration: 104 weeks |
| Mean age: int 43, cont 43 | Isoflav, mg/day: int 57.1, cont 7.2 (AU) | ||
| Soy protein difference: 10–44 g/day | |||
| Murkies 1995 | Participants: post-men (com) | Design: parallel | DO: int 5, cont 6 |
| Australia (Murkies et al., 1995) | Analyzed: int 24, cont 23 | Intervention: soy foods versus non-protein cont | Duration: 12 weeks |
| Mean age: int 54, cont 56 | Isoflav, mg/day: unclear (AU?) | ||
| Soy protein difference: 18 g/day | |||
| Nagata 1998 | Participants: pre-men, (com) | Design: parallel | DO: 0 |
| Japan (Nagata et al., 1998; Takatsuka et al., 2000) | Analyzed: int 31, cont 29 | Intervention: soy foods versus usual diet | Duration: 8 weeks |
| Mean age: int 26, cont 27 | Isoflav, mg/day: int 71, cont unclear (AU—No) | ||
| Soy protein difference: 12 g/day | |||
| Nahas 2004 | Participants: post-men (com) | Design: parallel | DO: none |
| Brazil (Nahas et al., 2004) | Analyzed: int 25, cont 25 | Intervention: soy foods versus placebo | Duration: 26 weeks |
| Mean age: int 54, cont 53 | Isoflav, mg/day: int 60, cont unclear (AU?) | ||
| Soy protein difference: 1 g/day | |||
| Nettleton 2004 | Participants: post-men (com) | Design: crossover | DO: 13 |
| USA (Greany et al., 2004, 2008; Nettleton et al., 2004, 2005a, b) | Analyzed: 20 HO br cancer, 20 without | Intervention: ISP versus milk protein | Duration: 6 weeks |
| Mean age: hO br cancer 60, without 56 | Isoflav, mg/day: int 44.4, cont unclear (AU) | ||
| Soy protein difference: 27 g/day | |||
| Nikander 2003 | Participants: post-men HO br cancer (com) | Design: crossover | DO: 6 |
| Finland (Nikander et al., 2003a, b, 2004a, b, 2005; Tormala et al., 2006) | Analyzed: 56 | Intervention: isoflav ext versus placebo | Duration: 12 weeks |
| Mean age: 54 | Isoflav, mg/day: int 114, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Scambia 2000 | Participants: post-men (com) | Design: parallel | DO: unclear |
| Italy (Scambia et al., 2000) | Analyzed: int 20, cont 19 | Intervention: isoflav versus placebo | Duration: 6 weeks |
| Mean age: int 54, cont 53 | Isoflav, mg/day: int 50, cont unclear (AU?) | ||
| Soy protein difference: 0 g/day | |||
| Spence 2005 | Participants: post-men (com, AFP) | Design: crossover | DO: 0 |
| USA (Spence et al., 2005) | Analyzed: 15 | Intervention: ISP versus low isoflavone ISP | Duration: 4 wks |
| Mean age: 58 | Isoflav, mg/day: int 65, cont 3.1 (AU) | ||
| Soy protein difference: 0 g/day versus ISP- or 40 g/day versus milk protein | |||
| Squadrito 2002 | Participants: post-men (com) | Design: parallel | DO: 3 int, 4 cont |
| Italy (Squadrito et al., 2002, 2003; Crisafulli et al., 2005; D’Anna et al., 2007) | Analyzed: int 27, cont 26 | Intervention: isoflav ext (genistein) versus placebo | Duration: 52 weeks |
| Mean age: int 56, cont 57 | Isoflav, mg/day: int 54, cont unclear (AU?) | ||
| Soy protein difference: 0 g/day | |||
| Uesugi 2003 | Participants: post-men (com) | Design: parallel | DO: int 0, cont 1 |
| Japan (Uesugi et al., 2003) | Analyzed: int 11, cont 10 | Intervention: isoflav ext versus dextrin | Duration: 12 weeks |
| Mean age: int 55, cont 53 | Isoflav, mg/day: int 61.8, cont unclear (AU—No) | ||
| Soy protein difference: 0 g/day | |||
| Uesugi 2004 | Participants: peri- and post-men (com) | Design: crossover | DO: unclear |
| Japan (Uesugi et al., 2004) | Analyzed: 58 | Intervention: isoflav ext versus placebo | Duration: 4 wks |
| Mean age: 58 | Isoflav, mg/day: int 42, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Upmalis 2000 | Participants: post-men, (com) | Design: parallel | DO: 31 int, 24 cont |
| USA (Upmalis et al., 1999, 2000) | Analyzed: int 59, cont 63 | Intervention: isoflav versus placebo | Duration: 12 weeks |
| Mean age: int 55, cont 54 | Isoflav, mg/day: int 50, cont unclear (AU?) | ||
| Soy protein difference: 0 g/day | |||
| Woods 2000 | Participants: post-men (com) | Design: crossover | DO: unclear |
| USA (Woods et al., 2000) | Analyzed: 85 | Intervention: isoflav ext versus placebo | Duration: 12 weeks |
| Mean age: unclear | Isoflav, mg/day: int 45, cont unclear (AU?) | ||
| Soy protein difference: unclear | |||
| Wu 2005 | Participants: post-men, (com, AFP) | Design: parallel | DO: 6 (unclear from which arms) |
| USA (Wu et al., 2005) | Analyzed: int 17, cont 20 | Intervention: soy food versus nil | Duration: 8 weeks |
| Mean age: int 57, cont 60 | Isoflav, mg/day: int 51, cont unclear (AU) | ||
| Soy protein difference: 15 g/day | |||
| Wu 2006 A and B | Participants: post-men (com) | Design: parallel | DO: A int 8, cont 4, B int 1, cont 7 |
| Japan (Wu et al., 2006a, b) | Analyzed: A: int 33, cont 33; B: int 31, cont 31 | Intervention: isoflav ext versus dextrin | Duration: 52 weeks |
| Mean age: A: int 54, cont 55, B: int 54, cont 55 | Isoflav, mg/day: int 75, cont unclear (AU) | ||
| Soy protein difference: 0 g/day | |||
| Zitterman 2004 | Participants: pre-men (com) | Design: crossover | DO: 3 |
| Germany (Zittermann et al., 2004) | Analyzed: 14 | Intervention: soy foods versus nil | Duration: 4 weeks |
| Mean age: 24 | Isoflav, mg/day: int 52, cont <0.1 (AU) | ||
| Soy protein difference: 22 g/day |
ISP, isolated soy protein; AU, aglycone units; Cont, control group; Int, intervention group; Com, community; Isoflav, isoflavone/s; FP, food provided; DO, dropouts; HC, hypercholesterolaemic; Br cancer, breast cancer; HO, history of; AFP, all food provided.