4.3. Intervention and Randomization
The product was a commercially available dietary supplement (Equopausa D. Ulrich, Paladin Pharma S.p.A., Turin, Italy) containing 200 mg of fermented soy (including 80 mg of isoflavone aglycones and 10 mg of equol) and 25 mg of resveratrol from Vitis vinifera. The proposed level of equol intake has been used in several clinical trials and reported to be effective for menopausal symptoms [Subjects were randomly assigned to receive the product or the placebo once a day. A restricted randomization list was created using PASS v.2008 (PASS, LLC. Kaysville, UT, USA) statistical software. The randomization sequence was stratified using a 10% maximum allowable % deviation with a 1:1 allocation ratio. The allocation sequence was concealed from the in-site study director in sequentially numbered, opaque, and sealed envelopes, reporting the unblinded treatment allocation. An independent technician dispensed either active or placebo products. Subjects, investigators, and collaborators were kept masked to product assignment.The intervention period with phytoestrogens that would elicit a beneficial response in menopausal women is controversial and usually ranges from 3 to 12 months. Given that a short-term treatment of 3 months could have been a potential limitation, we chose 12 months of intervention as a in previous study investigating the effects of equol on bone metabolism in postmenopausal women [