New equol supplement for relieving menopausal symptoms: randomized, placebo-controlled trial of Japanese women.
OBJECTIVE
Equol, a metabolite of the isoflavone daidzein, is hypothesized to play a major role in the health benefits of soy. We examined the effect of a new S-equol supplement on menopausal symptoms and mood states.


METHODS
We conducted a randomized, double-blind, placebo-controlled trial with our new equol supplement for 12 weeks with 134 Japanese women (aged 40-59 years). They were randomly assigned to three groups: placebo (n = 44), 10 mg of equol per day (EQ-1; n = 44), and 10 mg of equol three times per day (EQ-3; n = 46). Habitual isoflavone intake was limited to 20 mg/d. Participants completed menopausal symptom and Profile of Mood States questionnaires at baseline and postintervention. Physical examination and blood and 24-hour urine collection were performed at baseline and postintervention.


RESULTS
At baseline, total menopausal symptom score varied by menopausal and equol producer status (34.3% producers). A total of 127 participants (94.8%) completed the trial. No adverse effects were reported, except for a systemic rash in one EQ-3 woman. The anxiety scores of equol producers were lower than those of nonproducers (P < 0.05). Significant differences between premenopausal and perimenopausal/postmenopausal symptom scores were observed for anxiety, somatic, and total scores. After the EQ-3 intervention, perimenopausal/postmenopausal equol nonproducers showed significant decreases from baseline in all menopausal symptom scores except depression (P < 0.01). Compared with placebo, the EQ-3 group showed significant decreases in depression scores (P < 0.05), as well as significant decreases in Tension-Anxiety (P < 0.05), Depression-Dejection (P < 0.05) and Fatigue (P < 0.01) and increases in Vigor (P < 0.05) of the Profile of Mood States.


CONCLUSIONS
S-equol supplement improved mood-related symptoms in perimenopausal/postmenopausal equol nonproducers.
Ishiwata
Naoko
N
Department of Life Environments Management, Atomi University, Niza-shi, Saitama, Japan. ishiwata@atomi.ac.jp
Melby
Melissa K
MK
Mizuno
Shoichi
S
Watanabe
Shaw
S
D000328:Adult; D000339:Affect / Q000187:drug effects*; D001007:Anxiety / Q000188:drug therapy; D003863:Depression / Q000188:drug therapy; D019587:Dietary Supplements; D004311:Double-Blind Method; D060754:Equol; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage* / Q000009:adverse effects / Q000652:urine; D007986:Luteinizing Hormone / Q000097:blood; D008593:Menopause / Q000502:physiology*; D008875:Middle Aged; D048789:Phytoestrogens / Q000008:administration & dosage*; D010919:Placebos; D011374:Progesterone / Q000097:blood; D013025:Glycine max / Q000737:chemistry; D011795:Surveys and Questionnaires
C007610:4',7-dihydroxy-3,4-dihydroisoflavone; D007529:Isoflavones; D048789:Phytoestrogens; D010919:Placebos; D011374:Progesterone; D004958:Estradiol; D060754:Equol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone