Table 1.
Of the randomized blinded clinical trials with a control group on the influence of soy isoflavones on bone mineral density (listed chronologically).
| Author (Year) Country Observation Time |
Participants a
Age, y b Inclusion Criterion |
Test Report | Average Output Values BMD (g/cm2) | Jadad Scale | |
|---|---|---|---|---|---|
| Active Group | Control Group | ||||
| Potter [25] 1998 USA —6 months |
66/66 (–%) 60.8 ± 8.6 (39–83) 2.8 ± 8.8 ysm, BMI 27.8 ± 5.3 |
IFa 90 mg isof/d IFb 55.6 mg isof/d 40 g SP |
Con, 40 g casein and non-fat milk powder | LS: IFa 0.892; IFb 0.971; Con 0.940 | 5 |
| Alekel [26] 2000 USA —6 months |
69/69 (–%) 49.8 (44–59) 1.6 ysm, BMI 24.1 ± 3.4 |
IF 80.4 mg isof-ag/d 40 g SP |
Con, 40 g whey protein | LS: IF 0.981; Con 1.000 | 5 |
| Morabito [27] 2002 Italy —12 months |
90/90 (–%) 51.5 ± 3.1 (47–57) 6.5 ± 2.5 ysm, BMI 24 ± 3, FN BMD T-score > −1 SD |
IF tabl 54 mg Gen/d (purity ~98%) |
Pla tabl, nd. | LS: IF 0.915; Pla 0.934 FN: IF 0.687; Pla 0.689 |
3 c,e |
| Chen [28] 2003 Hong Kong —12 months |
203/175 (13.8%) 54.3 ± 3.3 (48–62) 4.1 ± 2.4 ysm, BMI 24.0 ± 3.5 |
IFa caps, 80 mg isof-ag/d IFb caps, 40 mg isof-ag/d (46.4% Dai, 38.8% Gly, 14.7% Gen) |
Pla caps, corn starch | LS: IFa 0.860; IFb 0.874; Pla 0.846 FN: IFa 0.680; IFb 0.688; Pla 0.679 TH: IFa 0.809; IFb 0.824; Pla 0.823 |
5 |
| Kaspers [29] 2004 The Netherlands —12 months |
202/175 (13.4%) 66.6 ± 4.8 (60–75) 17.9 ± 6.9 ysm, BMI 26.1 ± 3.8 |
IF 99 mg isof-ag/d (53% Gen, 41% Dai, 6% Gly), 25.6 g SP |
Con, 25.6 g milk protein | LS: IF 0.917; Con 0.895 | 5 |
| Olsen [30] 2004 Denmark —2 years |
107/89 (16.8%) 57.1 ± 7.6 (<75) 10.9 ysm, BMI 23.9 ± 3.9, LS BMD T-score < −1.0 SD |
IF 76 mg isof-ag/d, 17.5 g SP |
Con, 17.5 g SP without isof | LS: IF 0.865; Con 0.835 | 4 d |
| Arjmandi [31] 2005 USA —12 months |
87/62 (28.7%) 54.5 ± 5.0 (<65) 5.5 ± 5.0 ysm, BMI 27.9 ± 7.4 |
IF 60 mg isof/d, 25 g SP |
Con, 25 g SP without isof | LS: IF 0.944; Con 0.941 TH: IF 0.853; Con 0.871 |
4 c |
| Wu [32] 2006 Japan —6 months |
136/128 (5.9%) 54.4 ± 2.9 (45–60) 3.2 ± 1.8 ysm, BMI 21.1 ± 2.4 |
IF caps 75 mg isof/d, (47 mg isof-ag) |
Plac caps, dextrin | LS: IF 0.891; Pla 0.907 FN: IF 0.668; Pla 0.676 TH: IF 0.777; Pla 0.787 |
4 c |
| Ye [33] 2006 China —6 months |
90/84 (6.7%) 52.3 ± 3.3 (45–60) 2.6 ± 1.5 ysm, BMI < 30 |
IFa caps, 126 mg isof-ag/d, IFb caps, 84 mg isof-ag/d (52% Dai, 15% Gen, 33% Dai) |
Pla caps, starch | LS: IFa 0.892; IFb 0.839; Pla 0.864 FN: IFa 0.725; IFb 0.692; Pla 0.690 TH: IFa 0.813; IFb 0.796; Pla 0.792 |
5 |
| Huang [34] 2006 Taiwan —12 months |
43/42 (2.3%) 52.3 ± 2.5 (45–67) 4.4 ± 1.1 ysm, BMI 23.5 ± 3.6 |
IFa 200 mg isof-ag/d, IFb 100 mg isof-ag/d (71% Gen, 29% Dai) |
Pla tabl, nd. | LS: IFa 1.07; IFb 1.09; Pla 1.06 FN: IFa 0.85; IFb 0.80; Pla 0.78 |
2 c,d,e |
| Evans [35] 2007 USA —9 months |
61/43 (29.5%) 64.7 ± 5.1 (50–65) 8.3 ± 5.1 ysm, BMI 26.8 ± 2.4 |
IF 91.5 mg isof-ag/d, 25.6 g SP |
Con, 25.6 g milk protein | LS: IF 0.915, Con 0.939 FN: IF 0.673, Con 0.738 TH: IF 0.801, Con 0.857 |
4 d |
| Marini [36] 2007 Italy —2 years |
389/389 (–%) 54.5 ± 3.1 (49–67) 5.3 ± 3.5 ysm, BMI 25.1 ± 3.8, FN BMD T-score < –1.0 |
IF tabl, 54 mg Gen/d (czystość > 98%) |
Pla tabl, calcium carbonate | LS: IF 8.842, Pla 0.837 FN: IF 0.667, Pla 0.674 |
5 |
| Brink [37] 2008 Italy, France, The Netherlands —12 months |
300/237 (21.0%) 53 ± 3 2.7 ± 1.3 ysm, BMI 24.5 ± 2.1, LS BMD T-score > −2 |
IF 110 mg isof-ag/d (60–75% Gen, 25–35% Dai, 1–5% Gly), biscuits, bars |
Con, biscuits, cereal bars | LS: IF 0.983, Con 0.995 | 4 c |
| Vupadhyayula [38] 2009 USA —2 years |
203/157 (22.7%) 63.5 ± 4.5 (>55) 14.3 ± 5.4 ysm, BMI 26.3 ± 3.8, LS BMD T-score > −2.5 |
IF 90 mg isof/d, 25 g SP |
Con, 25 g milk protein | LS: IF 1.085, Con 1.104 FN: IF 0.873, Con 0.881 TH: IF 0.931, Con 0.910 |
5 |
| Kenny [39] 2009 USA —12 months |
131/97 (25.9%) 72.6 ± 5.9 (>60) 23.3 ± 9.5 ysm, BMI 28.1 ± 5.1, LS BMD T-score > −3.0 |
IF tabl, 105 mg isof-ag/d (Gen, Gly, Dai) |
Pla tabl, maltodextrin |
LS: IF 1.140, Pla 1.103 FN: IF 0.804, Pla 0.795 TH: IF 0.860, Pla 0.866 |
5 |
| Levis [40] 2011 USA —2 years |
248/177 (28.6%) 52.5 ± 3.3 (45–60) 5.5 ± 0.5 ysm, BMI 26.3 ± 3.3, LS BMD T-score ≥ −2.0 |
IF tabl, 200 mg isof/d | Pla tabl, nd. | LS: IF 1.146, Pla 1.132 FN: IF 0.940, Pla 0.937 TH: IF 0.990, Pla 0.982 |
5 |
| Tai [41] 2012 Taiwan —2 years |
431/399 (7.4%) 55.9 ± 3.8 (43–65) 5.1 ± 2.7 ysm, BMI 22.9 ± 2.5, LS BMD T-score > −1.0 |
IF caps, 300 mg isof-ag/d (57.5% Gen, 42.5% Dai) |
Pla caps, microcrystalline cellulose, xylitol | LS: IF 0.863, Pla 0.866 TH: IF 0.813, Pla 0.775 |
5 |
| Chilibeck [42] 2013 Canada —2 years |
351/298 (15,1%) 56.5 ± 6.8 5.0 ± 2.6 ysm, BMI 27.4 ± 4.1, LS BMD T-score > −2.51 |
IF tabl, 165 mg isof/d (105 mg isof-ag: Gen, Dai and Gly in a ratio of 1:1:0.2) |
Pla tabl, dicalcium phosphate, magnesium stearate, sorbitol | LS: IF 0.951, Pla 0.958 FN: IF 0.746, Pla 0.741 TH: IF 0.887, Pla 0.890 |
5 |
Data are means ± standard deviation. Abbreviations: BMD, bone mineral density (g/cm2); BMI, body mass index (kg/m2); caps, capsule; Con, control group; d, daily/day; Dai, daidzein; FN, femoral neck; Gen, genistein; Gly, glycitein; IF, active group; isof, isoflavones; isof-ag, isoflavones in the form of a glycons; LS, lumbar spine; nd., no data; Pla, placebo; SP, soy proteim; tabl, tablet, TH, total hip; T-score, the BMD of the subject to the average BMD of the young person; ysm, years since menopause (y). a sample size: randomisation/analysis (exclusion indicator), b range, c deduct one point because the method of randomization was described, but was inappropriate, d deduct one point because the method of blinding was described, but was inappropriate, e deduct one point because of no description of withdrawal and dropouts.