Liu Zhao-Min, Chen Bailing, Li Shuyi, Li Guoyi, Zhang Di, Ho Suzanne C, Chen Yu-Ming, Ma Jing, Qi Huang, Ling Wen-Hua
Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.
Department of Spine Surgery, the First Affiliated Hospital of Sun Yet-sen University, Guangzhou, Guangdong, PR China.
Ther Adv Endocrinol Metab. 2020 Jun 18;11:2042018820920555. doi: 10.1177/2042018820920555. eCollection 2020.
Human studies have demonstrated the beneficial effects of soy or isoflavones on bone metabolism. However, conflicting data remain. Equol is the intestinal metabolite of the isoflavone daidzein. The health benefits of soy are more pronounced in equol producers than those not producing equol. This 6-month randomized controlled trial aimed to examine the effect of whole soy (soy flour) and purified daidzein on bone turnover markers (BTMs) in Chinese postmenopausal women who are equol producers.
A total of 270 eligible women were randomized to either one of the three isocaloric supplements as follows: 40 g soy flour (whole soy group), 40 g low-fat milk powder + 63 mg daidzein (daidzein group), or 40 g low-fat milk powder (placebo group) given as a solid beverage daily for 6 months. The following fasting venous samples were collected at the baseline and end of the trial to analyze BTMs: serum cross-linked C-telopeptides of type I collagen, bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide, and 25(OH)D. Inflammation-related biomarkers, such as serum interleukin-6, tumor necrosis factor-alpha, C-reactive protein, transferrin, and homocysteine, were also tested to explore potential mechanisms.
A total of 253 subjects validly completed the study protocol. Urinary isoflavones suggested a good compliance to the treatments. Intention-to-treat and per-protocol analyses indicated no significant difference in the 6-month or percentage changes in the parameters of bone metabolism and inflammatory markers among the three treatment groups.
Whole soy and purified daidzein at provided dosages exhibited no significant effect on the bone metabolism and inflammation levels among Chinese equol-producing postmenopausal women.
ClinicalTrials.gov identifier NCT01270737.
人体研究已证明大豆或异黄酮对骨代谢有有益作用。然而，数据仍存在矛盾。雌马酚是异黄酮大豆苷元的肠道代谢产物。大豆对雌马酚产生者的健康益处比对不产生雌马酚者更为显著。这项为期6个月的随机对照试验旨在研究全豆（豆粉）和纯化大豆苷元对中国绝经后雌马酚产生者骨转换标志物（BTMs）的影响。
总共270名符合条件的女性被随机分为以下三种等热量补充剂之一：40克豆粉（全豆组）、40克低脂奶粉 + 63毫克大豆苷元（大豆苷元组）或40克低脂奶粉（安慰剂组），以固体饮料形式每天服用6个月。在试验基线和结束时采集以下空腹静脉样本以分析BTMs：血清I型胶原交联C末端肽、骨特异性碱性磷酸酶、骨钙素、I型前胶原N末端前肽和25(OH)D。还检测了炎症相关生物标志物，如血清白细胞介素-6、肿瘤坏死因子-α、C反应蛋白、转铁蛋白和同型半胱氨酸，以探索潜在机制。
总共253名受试者有效完成了研究方案。尿异黄酮表明对治疗的依从性良好。意向性分析和符合方案分析表明，三个治疗组在6个月时骨代谢参数和炎症标志物的变化或百分比变化没有显著差异。
对于中国绝经后雌马酚产生者，提供剂量的全豆和纯化大豆苷元对骨代谢和炎症水平没有显著影响。
ClinicalTrials.gov标识符NCT01270737。
