Effects of soy isoflavone supplementation on cognitive function in Chinese postmenopausal women: a double-blind, randomized, controlled trial.

OBJECTIVE To investigate whether soy-derived isoflavone extract improves performance in cognitive function and quality of life in Chinese postmenopausal women. DESIGN The study was a 6-month double-blind, randomized, placebo-controlled, parallel group trial. Participants were community-dwelling women aged 55 to 76 years; 191 eligible women were randomly assigned to receive a daily oral intake of 80 mg soy-derived isoflavones or an identical-appearing placebo for 6 months. Standardized neuropsychological tests of memory, executive function, attention, motor control, language, and visual perception and a global cognitive function assessment were administered face-to-face individually at baseline and at 6-months posttreatment. The validated Chinese version of the Short Form-36 was used for quality of life measurements. RESULTS Of the participants, 88% (168 women: 80 among the supplementation group and 88 among the placebo group) completed the trial. Intention-to-treat analysis, conducted for 176 participants with 6-month assessment results, revealed no significant differences in outcome measures between treatment groups. Subgroup analysis among the good compliers only (consumed at least 80% of the supplements or placebo; n = 168) and among the age groups younger or older than 65 years also indicated no significant differences for any outcome measures. Types of complaints of adverse events were similar in both treatment groups and included mainly gastrointestinal and musculoskeletal problems. CONCLUSIONS This 6-month trial indicates that 80-mg soy-derived isoflavone supplementation did not improve performance on standard neuropsychological tests and overall quality of life in generally healthy Chinese postmenopausal women.