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. 2023 Aug 27;8(36):32271–32293. doi: 10.1021/acsomega.3c03741

Table 5. Global Clinical Trial Studies on Daidzein Based Products to Access Their Effects in Various Conditions.

no. clinical trial no. research topic current status (phase) state or condition sample size sponsor location/country
1 NCT01270737 (U.S.) whole soy and daidzein supplementation in a double-blind randomized controlled study to lower blood pressure in prehypertensive postmenopausal chinese women completed (phase NA) hypertension 270 Chinese University of Hong Kong Center of Research and Promotion of Women’s Health, Hong Kong, China
2 NCT00179556 (U.S.) menopausal hot flashes with soy isoflavones completed (phase 3) menopausal symptoms 210 1. Beth Israel Deaconess Medical Center Boston, MA
            2. Nichimo Tokyo, Japan
3 NCT01556737 (U.S.) impact of two distinct isoflavone supplements on gene expression of postmenopausal women completed (phase NA) postmenopausal 72 Wageningen University Wageningen, Gelderland, Netherlands
4 NCT00951912 (U.S.) studying how soy isoflavones affect postmenopausal Chinese women with impaired glucose regulation, metabolism of lipids and glucose completed (phase NA) type 2 diabetes mellitus 165 1. Sun Yat-sen University First Affiliated Hospital, Sun Yat-sen University; Guangzhou, Guangdong, China
            2. Nutrition Society of China  
            3. International Danone Institute  
            4. Department of Health of Guangdong Province  
5 IRCT20100414003706N35 (Iran) effect of a Menohelp Barij capsule on early menopause signs and symptoms: randomized placebo-controlled study completed (phase 3) menopausal and other perimenopausal disorders 100 Barij Essence Pharmaceutical Co., Kashan, Iran Tabriz Public Health Centers, Tabriz, East Azarbaijan
6 EudraCT2020-000228-20 (Europe) randomized controlled study of probiotic dietary intervention in polycystic ovary syndrome ongoing (phase 1) polycystic ovary syndrome (PCOS) 180 Medical University of Graz, Graz, Austria Austria
7 UMIN000017190 (Japan) plasma kinetics of the isoflavones daidzein and genistein in healthy females following consumption of fermented soymilk products completed (phase NA) healthy women (18–55 years) (menstrually active) 10 1. Kagawa Nutrition University Japan
            2. Yakult Honsha Co., Ltd.  
8 UMIN000019450 (Japan) effects of daily use of the isoflavone-rich soybean “Yukipirika” on the improvement of bone metabolism and menopausal symptoms examined in a random, double-blind, placebo-controlled, parallel group comparison study completed (phase NA) healthy adults and menopausal women 20 1. Hokkaido Information University Japan
            2. Northern Advancement Center for Science & Technology  
9 ChiCTR2100043116 (China) clinical study on application of PRF/phytoestrogen daidzein complex method in postmenopausal women with osteoporosis after tooth extraction recruiting (not started) alveolar bone loss 90 1. Stomatology Department, Inner Mongolia Medical University Affiliated Hospital, Inner Mongolia Autonomous Area, China Mongolia Medical University Affiliated Hospital, China
            2. Inner Mongolia Medical University Affiliated Hospital, China  
10 ChiCTR2000034019 (China) single-arm exploratory trail of combination of abiraterone with daidzein in the treatment of castration resistant prostate cancer recruiting (not started) prostate cancer 30 Shanghai Tongji Hospital, Shanghai, China Shanghai Tongji Hospital, Shanghai, China
11 ChiCTR-TRC-11001222 (China) preclinical trial of daidzein supplement for postmenopausal osteoporosis completed (phase NA) postmenopausal osteopenia or osteoporosis 80 1. Third Military Medical University, Chongqing, China, Third Military Medical University, Chongqing, China
            2. National Natural Science Fund of China, Beijing, China  
12 ChiCTR-TRC-10001048 (China) effects of daidzein on serum lipid profile in hypercholesterolemia patients with different equol metabolism phenotypes completed (phase NA) hypercholesterolemia 400 1. Third Military Medical University, Chongqing, China Third Military Medical University, Chongqing, China
            2. National Natural Science Fundation of China  
13 NCT00661856 impact of soy isoflavones on physical performance indicators and bone mineral density completed (phase NA) bone diseases, bone metabolism 203 1. Creighton University Creighton University Medical Center, Omaha, NE
            2. Solae, LLC  
14 NCT00924339 evaluation of urinary isoflavone excretion as compliance indicators in a soy food intervention trial (SOY FIT) for treatment of children and adolescents with familial hypercholesterolemia to confirm the beneficial impact of a soy-substituted diet completed but not verified (phase NA) familial hypercholesterolemia 30 Medical University of Vienna Pediatrics Division, Division of Nutrition and Metabolism, Medical University of Vienna, Vienna, Austria
15 NCT04871750 prospective, randomized controlled study on the effects of dietary soy protein on facial wrinkles not started; completion June 2023 (phase NA) photoaging 80 1. Integrative Skin Science and Research Sacramento, CA
            2. United Soybean Board  
16 NCT00491595 soy isoflavones: phase 1 multiple-dose clinical investigation in healthy postmenopausal women phase 1 completed drug toxicity 36 National Cancer Institute (NCI) at University of North Carolina Chapel Hill, NC
17 NCT05073523 randomized controlled study to evaluate dose–response associations for certain foods’ dietary biomarkers ongoing; completion May 2022 (phase NA) healthy recruiting Chalmers University of Technology Department of Food & Nutrition and Sport Science Recruitment, University of Gothenburg, Gothenburg, Sweden
18 NCT01497977 impact of phytoestrogens on serum lipids in postmenopausal women completed (phase 4) low serum lipid levels 74 American Medical Academy, Serbia Ultramedica Clinic, American Medical Academy, Belgrade, Serbia
19 NCT01463436 study of soy isoflavone 100 mg/day in postmenopausal women to elaborate effect of soy isoflavone in endothelial function and to reduce oxidative stress completed (phase 3) cardiovascular disease, osteoporosis 200 Trisakti University Trisakti University, Jakarta, Indonesia
20 NCT01048606 synergistic effect of exercise and phytoestrogens on postmenopausal women risk factors for CVD completed (phase 4) overweight 45 Canadian Institutes of Health Research (CIHR), Université de Sherbrooke Centre of Research on Aging, CSSS-IUGS, Sherbrooke, Canada
21 NCT00669656 men with biochemical recurrence of prostate cancer after initial local treatment: phase 2 study of combined herbal therapy completed (phase 2) prostate cancer 43 University of Southern California Norris Comprehensive Cancer Center, USC, Los Angeles, CA
22 NCT00205179 Alzheimer’s disease: potential benefit of isoflavones completed (phase 2) Alzheimer’s disease 72 1. University of Wisconsin—Madison University of Wisconsin—Madison, Madison, WI
            2. National Institute on Aging (NIA)