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The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial

BACKGROUND: A double blind clinical trial was performed to evaluate whether the polycystic ovary syndrome (PCOS)-specific serum markers and metabolic parameters would change in the women with PCOS during the three-month administration of oligopin. METHODS: In this double-blind multicenter trial, we...

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Autores principales: Qorbani, Mostafa, Sanginabadi, Milad, Mohajeri-Tehrani, Mohammad Reza, Karimi, Sara, Gerami, Hadis, Mahdavi-Gorabi, Armita, Shirzad, Nooshin, Samadi, Majid, Baygi, Fereshteh, Hosseini, Saeed, Mansour, Asieh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779998/
https://www.ncbi.nlm.nih.gov/pubmed/33408691
http://dx.doi.org/10.3389/fendo.2020.590392
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author Qorbani, Mostafa
Sanginabadi, Milad
Mohajeri-Tehrani, Mohammad Reza
Karimi, Sara
Gerami, Hadis
Mahdavi-Gorabi, Armita
Shirzad, Nooshin
Samadi, Majid
Baygi, Fereshteh
Hosseini, Saeed
Mansour, Asieh
author_facet Qorbani, Mostafa
Sanginabadi, Milad
Mohajeri-Tehrani, Mohammad Reza
Karimi, Sara
Gerami, Hadis
Mahdavi-Gorabi, Armita
Shirzad, Nooshin
Samadi, Majid
Baygi, Fereshteh
Hosseini, Saeed
Mansour, Asieh
author_sort Qorbani, Mostafa
collection PubMed
description BACKGROUND: A double blind clinical trial was performed to evaluate whether the polycystic ovary syndrome (PCOS)-specific serum markers and metabolic parameters would change in the women with PCOS during the three-month administration of oligopin. METHODS: In this double-blind multicenter trial, we randomly assigned 80 PCOS women, based on a 1:1 ratio, to receive oligopin (n= 40) or maltodextrin as placebo (n = 40) for up to 3 months. As PCOS-specific outcomes, we investigated the changes in testosterone, sex hormone binding globulin (SHBG), free androgen index (FAI), dehydroepiandrosterone (DHEA), follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Secondary end points were metabolic (fasting glycaemia, hemoglobin A1c (HbA1c), lipids, insulin resistance (HOMA-IR)), anthropometrics parameters and blood pressure from the baseline to the end of treatment. We investigated serum transaminase, alkaline phosphatase (ALP), creatinine (Cr) and blood urea nitrogen (BUN) levels as hepatic and kidney outcomes, respectively. RESULTS: The first participant was enrolled on April 18, 2018, and the last study visit took place on May 14, 2019. PCOS-specific serum parameters did not change during the three-month administration of oligopin (p > 0.05), except for a small increase in the FSH levels (p=0.03). Oligopin neither changed the metabolic profile nor the anthropometric parameters or blood pressure. ALP levels was significantly increased in placebo group, as compared with oligopin (p=0.01). CONCLUSION: Oligopin supplementation does not seem to be exerting a beneficial effect on both hormonal and metabolic parameters in the women with PCOS. CLINICAL TRIAL REGISTRATION: www.irct.ir, identifier IRCT20140406017139N3.
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spelling pubmed-77799982021-01-05 The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial Qorbani, Mostafa Sanginabadi, Milad Mohajeri-Tehrani, Mohammad Reza Karimi, Sara Gerami, Hadis Mahdavi-Gorabi, Armita Shirzad, Nooshin Samadi, Majid Baygi, Fereshteh Hosseini, Saeed Mansour, Asieh Front Endocrinol (Lausanne) Endocrinology BACKGROUND: A double blind clinical trial was performed to evaluate whether the polycystic ovary syndrome (PCOS)-specific serum markers and metabolic parameters would change in the women with PCOS during the three-month administration of oligopin. METHODS: In this double-blind multicenter trial, we randomly assigned 80 PCOS women, based on a 1:1 ratio, to receive oligopin (n= 40) or maltodextrin as placebo (n = 40) for up to 3 months. As PCOS-specific outcomes, we investigated the changes in testosterone, sex hormone binding globulin (SHBG), free androgen index (FAI), dehydroepiandrosterone (DHEA), follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Secondary end points were metabolic (fasting glycaemia, hemoglobin A1c (HbA1c), lipids, insulin resistance (HOMA-IR)), anthropometrics parameters and blood pressure from the baseline to the end of treatment. We investigated serum transaminase, alkaline phosphatase (ALP), creatinine (Cr) and blood urea nitrogen (BUN) levels as hepatic and kidney outcomes, respectively. RESULTS: The first participant was enrolled on April 18, 2018, and the last study visit took place on May 14, 2019. PCOS-specific serum parameters did not change during the three-month administration of oligopin (p > 0.05), except for a small increase in the FSH levels (p=0.03). Oligopin neither changed the metabolic profile nor the anthropometric parameters or blood pressure. ALP levels was significantly increased in placebo group, as compared with oligopin (p=0.01). CONCLUSION: Oligopin supplementation does not seem to be exerting a beneficial effect on both hormonal and metabolic parameters in the women with PCOS. CLINICAL TRIAL REGISTRATION: www.irct.ir, identifier IRCT20140406017139N3. Frontiers Media S.A. 2020-12-21 /pmc/articles/PMC7779998/ /pubmed/33408691 http://dx.doi.org/10.3389/fendo.2020.590392 Text en Copyright © 2020 Qorbani, Sanginabadi, Mohajeri-Tehrani, Karimi, Gerami, Mahdavi-Gorabi, Shirzad, Samadi, Baygi, Hosseini and Mansour http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Endocrinology
Qorbani, Mostafa
Sanginabadi, Milad
Mohajeri-Tehrani, Mohammad Reza
Karimi, Sara
Gerami, Hadis
Mahdavi-Gorabi, Armita
Shirzad, Nooshin
Samadi, Majid
Baygi, Fereshteh
Hosseini, Saeed
Mansour, Asieh
The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial
title The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial
title_full The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial
title_fullStr The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial
title_full_unstemmed The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial
title_short The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial
title_sort effect of oligopin supplementation on hormonal and metabolic profiles in the polycystic ovary syndrome: a randomized controlled trial
topic Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779998/
https://www.ncbi.nlm.nih.gov/pubmed/33408691
http://dx.doi.org/10.3389/fendo.2020.590392
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