. 2016 Jul 19;5:e30. doi: 10.1017/jns.2016.18

Table 4.

Randomised clinical trial results reporting the effect of soya isoflavone interventions and equol producer (EP) status on blood pressure and vasculature parameters^*

First author, year	CHD risk factor measured	Effect of isoflavone on CHD risk factors	Result marker^†	Effect of EP status on CHD risk factors	Result marker‡
Acharjee et al. (2015)⁽²⁷⁾	DBP	Reduction in DBP in women with and without MetS (5·4 %, P = 0·03 and 3·4 %, P = 0·0008, respectively) after the soya intervention	+	EP with and without MetS had reduced DBP (7·7 %, P = 0·02 and 3·3 %, P = 0·02, respectively) after the soya intervention compared with placebo. There were NS effects on NEP with or without MetS in DBP	+
Clerici et al. (2007)⁽⁵⁶⁾	FMD	Increase in FMD (2 (sem 0·8) %; P = 0·012) after the soya intervention compared with placebo	+	Increase in FMD in EP from baseline concentrations (P = 0·03) after the soya intervention, unlike in NEP	+
Welty et al. (2007)⁽⁵⁵⁾	SBP	Reduction in SBP in hypertensive women (9·9 %, P = 0·003) and normotensive women (5·2 %, P < 0·001) after the soya intervention compared with the placebo	+	In the 8 of 12 hypertensive women with LDL-C levels greater than 140 mg/dl (>3·63 mmol/l), the percentage reduction in SBP was positively correlated with the level of equol in the soya diet arm (r 0·80; P = 0·02)	+
Curtis et al. (2013)⁽³⁰⁾	BP, DBP, MAP, PWV	The flavonoid intervention had a NS effect on BP and PWV compared with placebo. The flavonoid intervention had a NS greater reduction compared with placebo in DBP (P = 0·06) and MAP (P = 0·06)	0	EP compared with NEP had reduced BP (P = 0·01), DBP (EP: −2·24 (se 1·31) mmHg; NEP: 1·00 (se 0·89) mmHg; P < 0·01), MAP (EP: −1·24 (se 1·30) mmHg; NEP: 1·90 (se 1·08) mm Hg; P = 0·01) and PWV (EP: −0·68 (se 0·40) m/s; NEP: 0·32 (se 0·55) m/s; P = 0·001). In EP, an inverse correlation between DBP and urinary equol concentrations was observed (r −0·44, P = 0·08)	+
Acharjee et al. (2015)⁽²⁷⁾	SBP	Reduction of SBP in women with and without MetS (5·9 %, P < 0·001 and 6·7 %, P = 0·01, respectively) after the soya intervention compared with placebo	+	SBP changed in both EP (6·4 %, P < 0·001) and NEP (5·4 %, P = 0·003) in women without MetS compared with placebo. In women with MetS, NS change in SBP in EP or NEP	0
Hallund et al. (2006)⁽³⁶⁾	NMD, NOx, NOx:ET-1, SAC	Reductions in NMD (15·5 % v. 12·4 %, P = 0·03), NOx (P = 0·003), NOx:ET-1 (P = 0·005) and SAC (P = 0·04) after the soya intervention compared with placebo	+	NS interaction between EP status and vascular responses to isoflavones and placebo treatment	0
Reverri et al. (2015)⁽⁶³⁾	AIx	Reduction in AIx after the soya intervention compared with placebo (P = 0·03)	+	EP status had a NS effect on AIx after the soya intervention	0
Steinberg et al. (2003)⁽⁴⁸⁾	PFV	Reduction in PFV after the soya intervention compared with placebo (37 %; P = 0·03)	+	EP status had a NS effect on PFV after the soya intervention	0
Welty et al. (2007)⁽⁵⁵⁾	DBP	Reduction in DBP after the soya intervention in hypertensive women (6·8 % mmHg, P = 0·001) and normotensive women (2·9 %; P = 0·02) compared with the placebo	+	EP status had a NS effect on DBP after the soya intervention	0
Wong et al. (2012)⁽⁶⁶⁾	SBP, DBP	Reductions in DBP and SBP after the soya treatments compared with placebo (P values not provided)	+	EP status had a NS effect on the risk factors after the soya treatments	0
Curtis et al. (2013)⁽³⁰⁾	SBP, total plasma NO concentrations, ET-1	The flavonoid intervention had a NS effect on the risk factors compared with placebo. There was a NS greater decrease in SBP the flavonoid group compared with placebo (P = 0·07)	0	EP status had a NS effect on the risk factors after the flavonoid intervention	0
Hall et al. (2005)⁽³⁴⁾	BP, ET-1, vWF	The isoflavone intervention had a NS effect on the risk factors compared with placebo	0	EP status had a NS effect on the risk factors after the isoflavone intervention	0
Hall et al. (2006)⁽³⁵⁾	Mean SBP, Mean DBP	The isoflavone intervention had a NS effect on the risk factors compared with placebo	0	EP status had a NS effect on the risk factors after the isoflavone intervention	0
Hallund et al. (2006)⁽³⁶⁾	FMD, ET-1, BP, IAC, arterial volume, arterial distensibility, SVR	The isoflavone intervention had a NS effect on the risk factors compared with placebo. There was a NS greater increase in SVR after the isoflavone intervention compared with placebo (P = 0·06)	0	NS interaction between EP status and the risk factors after the isoflavone intervention	0
Hodis et al. (2011)⁽¹⁴⁾	CIMT	There was a NS greater reduction in CIMT progression after the isoflavone intervention compared with control (16 %; P = 0·36)	0	EP status had a NS effect on CIMT progression rate after the isoflavone intervention	0
Kreijkamp-Kaspers et al. (2005)⁽³⁷⁾	DBP, %FMD	The soya intervention had a NS effect on the risk factors compared with placebo	0	EP status had a NS effect on the risk factors after the soya intervention	0
Meyer et al. (2004)⁽⁵⁹⁾	HDL-C, MAP, SBP, DBP, arterial compliance	The soya intervention had a NS effect on the risk factors compared with placebo	0	EP status had a NS effect on the risk factors after the soya intervention	0
Nikander et al. (2004)⁽⁴³⁾	BP	The isoflavonoid intervention had a NS effect on the risk factors compared with placebo	0	EP status had a NS effect on the risk factors after the isoflavonoid intervention	0
Pusparini & Hidayat (2015)⁽⁴⁵⁾	NO	The isoflavone intervention had a NS effect on NO compared with placebo	0	EP status had a NS effect on NO after the isoflavone intervention	0
Reverri et al. (2015)⁽⁶³⁾	Reactive hyperemia index	The soya intervention had a NS effect on the risk factor compared with placebo	0	EP status had a NS effect on the risk factor after the soya intervention	0
Steinberg et al. (2003)⁽⁴⁸⁾	Brachial artery vessel diameter, ET-1, total NO	The soya interventions had a NS effect on the risk factors	0	EP status had a NS effect on the risk factors after the soya interventions	0
Törmälä et al. (2008)⁽⁴⁹⁾	AIx, EFI	The soya intervention had a NS effect on the risk factors compared with placebo	0	EP status had a NS effect on the risk factors after the soya intervention. EP taking tibolone had lower AIx (P = 0·01) and EPI (P = 0·009) compared with NEP	0
Törmälä et al. (2007)⁽⁵¹⁾	SBP, DBP, MAP	The soya intervention had a NS effect on the risk factors compared with placebo	0	EP status had a NS effect on the risk factors after the soya intervention. EP women taking tibolone had lower SBP (P = 0·02), DBP (P = 0·01) and MAP (P = 0·007) which was maintained after the soya intervention	0
Kreijkamp-Kaspers et al. (2005)⁽³⁷⁾	SBP	Increase in SBP after the soya intervention compared with placebo (4·3 mmHg; P = 0·04)	–	EP status had a NS effect on the risk factors after the soya intervention	0

DBP, diastolic blood pressure; MetS, metabolic syndrome; NEP, non-equol producer; FMD, flow-mediated dilation; SBP, systolic blood pressure; LDL-C, LDL-cholesterol; BP, blood pressure; MAP, mean arterial pressure; PWV, carotid to femoral pulse wave velocity; NMD, nitroglycerine-mediated endothelium-independent vasodilation; NOx, nitrate and nitrite; ET-1, endothelin-1; SAC, systemic arterial compliance; AIx, augmentation index; PFV, peak flow velocity; vWF, von Willebrand factor; IAC, isobaric arterial compliance; SVR, systemic vascular resistance; CIMT, carotid artery intima-media thickness; HDL-C, HDL-cholesterol; EFI, endothelial function index.

Results are first stratified by the impact of EP status and then the impact of the soya isoflavone interventions on each of the lipid risk factors.

^†

+, Beneficial effect of soya isoflavones on risk factors of CHD; 0, negligible effect of soya isoflavones on risk factors of CHD; –, adverse effect of soya isoflavones on risk factors of CHD.

^‡

+, Beneficial effect of EP status on risk factors of CHD after soya intervention; 0, negligible effect of EP status on CHD risk factors after soya intervention; –, adverse effect of EP status on risk factors of CHD after soya intervention.