PMID- 34330312 OWN - NLM STAT- MEDLINE DCOM- 20220125 LR - 20220125 IS - 1757-2215 (Electronic) IS - 1757-2215 (Linking) VI - 14 IP - 1 DP - 2021 Jul 31 TI - Randomized double blind clinical trial evaluating the Ellagic acid effects on insulin resistance, oxidative stress and sex hormones levels in women with polycystic ovarian syndrome. PG - 100 LID - 10.1186/s13048-021-00849-2 [doi] LID - 100 AB - OBJECTIVE: The design of this study was due to the report of the antioxidant properties of Ellagic acid (EA) for its evaluation on the Insulin resistance (IR), oxidative stress and sex hormones levels in women with polycystic ovarian syndrome (PCOS). METHODS: In this randomized, double-blind, placebo-controlled clinical trial, 60 patients were recruited. Patients were randomly allocated consumed a capsule containing 200 mg of EA per day (n = 30) or placebo (n = 30) for 8 weeks. The fasting blood sugar (FBS), insulin, IR, total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL), high density lipoprotein (HDL), total antioxidant capacity (TAC), Malondialdehyde (MDA), C-reactive protein (CRP), Tumor necrosis factor-alpha (TNF-alpha), sex hormones and anti-mullerian hormone (AMH) were measured at the beginning and end of the study. RESULT: At the end of the study, the mean of FBS, insulin, IR, TC, TG, LDL, MDA, CRP, TNF-alpha, total testosterone, prolactin and AMH were significantly decreased in the intervention group compared to the placebo group (P < 0.05). Also, there was a significant increase in the mean of TAC after supplementation with EA (P < 0.05). At the end of the study, no significant changes were observed in the mean of anthropometric factors, physical activity and food intake (P > 0.05). CONCLUSION: EA supplementation can be helpful as a diet supplement in women with PCOS through improvement in insulin resistance. This supplement may be used to reduce metabolic disorders in women. TRIAL REGISTRATION: This study was retrospectively (07-07-2019) registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( IRCT20141025019669N12 ). CI - (c) 2021. The Author(s). FAU - Kazemi, Mahnaz AU - Kazemi M AD - Department of Nutrition, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran. FAU - Lalooha, Fatemeh AU - Lalooha F AUID- ORCID: 0000-0003-4241-7958 AD - Department of Obstetrics and Gynecology, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran. FAU - Nooshabadi, Mohammadreza Rashidi AU - Nooshabadi MR AUID- ORCID: 0000-0002-1707-0094 AD - Department of Pharmacology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. FAU - Dashti, Fariba AU - Dashti F AD - Department of Nutrition, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran. FAU - Kavianpour, Maria AU - Kavianpour M AUID- ORCID: 0000-0002-8047-8754 AD - Department of Applied Cell Sciences, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran. Kavianpour.maria@gmail.com. FAU - Haghighian, Hossein Khadem AU - Haghighian HK AUID- ORCID: 0000-0002-7445-1846 AD - Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. khademnut@yahoo.com. AD - Department of Nutrition, Faculty of Health Qazvin, University of Medical Sciences, Qazvin, Iran. khademnut@yahoo.com. LA - eng GR - IR.QUMS.REC.1398.033/Qazvin University of Medical Sciences/ PT - Journal Article PT - Randomized Controlled Trial DEP - 20210731 PL - England TA - J Ovarian Res JT - Journal of ovarian research JID - 101474849 RN - 0 (Gonadal Steroid Hormones) RN - 19YRN3ZS9P (Ellagic Acid) SB - IM MH - Adolescent MH - Adult MH - Double-Blind Method MH - Ellagic Acid/pharmacology/*therapeutic use MH - Female MH - Gonadal Steroid Hormones/*immunology MH - Humans MH - Insulin Resistance/*immunology MH - Middle Aged MH - Oxidative Stress/*drug effects MH - Retrospective Studies MH - Young Adult PMC - PMC8325180 OTO - NOTNLM OT - Anti-mullerian hormone OT - Ellagic acid OT - Insulin resistance OT - Polycystic ovarian syndrome OT - Stress oxidative COIS- We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome. EDAT- 2021/08/01 06:00 MHDA- 2022/01/27 06:00 PMCR- 2021/07/31 CRDT- 2021/07/31 06:14 PHST- 2021/03/07 00:00 [received] PHST- 2021/07/22 00:00 [accepted] PHST- 2021/07/31 06:14 [entrez] PHST- 2021/08/01 06:00 [pubmed] PHST- 2022/01/27 06:00 [medline] PHST- 2021/07/31 00:00 [pmc-release] AID - 10.1186/s13048-021-00849-2 [pii] AID - 849 [pii] AID - 10.1186/s13048-021-00849-2 [doi] PST - epublish SO - J Ovarian Res. 2021 Jul 31;14(1):100. doi: 10.1186/s13048-021-00849-2.