Yari Zahra, Tabibi Hadi, Najafi Iraj, Hedayati Mehdi, Movahedian Mina
National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.
Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, 46, West Arghavan St., Farahzadi Blvd., Shahrak Qods, P. O. Box 19395-4741, Tehran, Islamic Republic of Iran.
Int Urol Nephrol. 2020 Jul;52(7):1367-1376. doi: 10.1007/s11255-020-02523-w. Epub 2020 Jun 1.
The aim of this study was to investigate the effects of soy isoflavones on serum markers of bone formation and resorption in peritoneal dialysis (PD) patients.
In this randomized, double-blind, placebo-controlled trial, 40 PD patients were randomly assigned to either the soy isoflavone or the placebo group. The patients in the soy isoflavone group received 100 mg soy isoflavones daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of the 8th week, 7 ml of blood was obtained from each patient after a 12- to 14-h fast and serum concentrations of bone formation markers (osteocalcin and bone alkaline phosphatase), bone resorption markers [N-telopeptide and receptor activator of nuclear factor kappa B ligand (RANKL)], and osteoprotegerin as an inhibitor of bone resorption were measured.
Serum N-telopeptide concentration decreased significantly up to 27% in the soy isoflavone group at the end of week 8 compared to baseline (P = 0.003). Also, serum RANKL concentration reduced significantly up to 17% in the soy isoflavone group at the end of week 8 compared to baseline (P = 0.03). These bone resorption markers did not significantly change in the placebo group during the study. There were no significant differences between the two groups in mean changes of serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin.
This study indicates that daily administration of 100 mg soy isoflavone supplement to PD patients reduces serum N-telopeptide and RANKL which are two bone resorption markers. CLINICALTRIALS.GOV: NCT03773029, 2018.
本研究旨在探讨大豆异黄酮对腹膜透析（PD）患者骨形成和骨吸收血清标志物的影响。
在这项随机、双盲、安慰剂对照试验中，40例PD患者被随机分为大豆异黄酮组或安慰剂组。大豆异黄酮组患者每天服用100毫克大豆异黄酮，持续8周，而安慰剂组服用相应的安慰剂。在基线和第8周结束时，每位患者在禁食12至14小时后采集7毫升血液，测量骨形成标志物（骨钙素和骨碱性磷酸酶）、骨吸收标志物[N-端肽和核因子κB受体激活剂配体（RANKL）]以及作为骨吸收抑制剂的骨保护素的血清浓度。
与基线相比，大豆异黄酮组在第8周结束时血清N-端肽浓度显著降低，降幅高达27%（P = 0.003）。此外，与基线相比，大豆异黄酮组在第8周结束时血清RANKL浓度显著降低，降幅高达17%（P = 0.03）。在研究期间，安慰剂组的这些骨吸收标志物没有显著变化。两组在血清骨钙素、骨碱性磷酸酶和骨保护素的平均变化方面没有显著差异。
本研究表明，每天给PD患者补充100毫克大豆异黄酮可降低血清N-端肽和RANKL，这两种都是骨吸收标志物。临床试验注册编号：NCT03773029，2018年。
