OBJECTIVE

To investigate the effects of a supplement containing soy isoflavones and Actaea racemosa L. on several coronary heart disease (CHD) risk markers in menopausal women.

METHODS

Randomized, placebo-controlled, double-blind study.

METHODS

Nine hospitals in The Netherlands.

METHODS

One hundred twenty-four menopausal women.

METHODS

Daily placebo (n = 64) or supplement containing soy isoflavones and Actaea racemosa L. (n = 60) for 12 weeks.

METHODS

Fasting blood concentrations of asymmetric dimethylarginine (ADMA), lipids, and C-reactive protein (CRP) at baseline and week 12.

RESULTS

In the supplement group, total cholesterol and low-density lipoprotein cholesterol showed a small absolute reduction at week 12 (-0.2, 95% confidence interval [CI] -0.3 to -0.0; and -0.2, 95% CI -0.3 to -0.0; respectively). Concentrations of ADMA, triglycerides, lipoprotein(a), and CRP did not change significantly. Analysis of covariance over the 12-week study period revealed no significant between-group differences for all parameters. No significant correlations were found between the concentrations of isoflavones and the CHD risk markers investigated.

CONCLUSIONS

Twelve-week administration of a supplement containing soy isoflavones and Actaea racemosa L. had little or no influence on the CHD risk markers studied. This supplement probably has neither protective nor adverse effects on the cardiovascular system; however, large long-term studies are needed to test this.