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The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial

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08 September 2020 Editor's Note: The Editor-in-Chief is currently investigating this article as concerns have been raised about integrity of the clinical trial reported here. There is also an ongoing investigation by the Iranian National Committee for Ethics in Biomedical Researches. Further editorial action will be taken as appropriate once the investigation into the concerns is complete and all parties have been given an opportunity to respond in full.

Abstract

Data on the effects of synbiotic supplementation on glycemic control, lipid profiles, and atherogenic index of plasma (AIP) of women with polycystic ovary syndrome (PCOS) are limited. The purpose of this study was to assess the effects of synbiotic supplementation on glycemic control and lipid profiles in women with PCOS. A prospective, randomized, double-blind, placebo-controlled trial was done at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017. Sixty women with PCOS were randomized to intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 109 CFU/g each) plus 800 mg inulin (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related variables. Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (− 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (− 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. − 0.01 ± 0.03, P < 0.001). In addition, significant decreases in serum triglycerides (− 16.2 ± 31.4 vs. + 5.8 ± 23.1 mg/dL, P = 0.003), VLDL-cholesterol concentrations (− 3.3 ± 6.3 vs. + 1.1 ± 4.6 mg/dL, P = 0.003), and AIP (− 0.05 ± 0.08 vs. − 0.003 ± 0.10 mg/dL, P = 0.03) were seen following the supplementation of synbiotic compared with the placebo. Overall, we found that synbiotic supplementation to women with PCOS for 12 weeks had beneficial effects on markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP, but did not influence other lipid profiles. Trial registration: www.irct.ir: IRCT201604015623N71.

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  • 08 September 2020

    Editor's Note: The Editor-in-Chief is currently investigating this article as concerns have been raised about integrity of the clinical trial reported here. There is also an ongoing investigation by the Iranian National Committee for Ethics in Biomedical Researches. Further editorial action will be taken as appropriate once the investigation into the concerns is complete and all parties have been given an opportunity to respond in full.

Abbreviations

AIP:

Atherogenic index of plasma

PCOS:

Polycystic ovary syndrome

VLDL:

Very-low-density lipoprotein

CFU:

Colony forming units

T2DM:

Type 2 diabetes mellitus

CVD:

Cardiovascular diseases

GDM:

Gestational diabetes mellitus

FPG:

Fasting plasma glucose

METs:

Metabolic equivalents

CVs:

Coefficient variances

HOMA-IR:

Homeostatic model of assessment for insulin resistance

QUICKI:

Quantitative insulin sensitivity check index

SCFA:

Short-chain fatty acids

NF-κB:

Nuclear factor-kappaB

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Acknowledgments

The present study was supported by a grant from the Vice-chancellor for Research, Kashan University of Medical Sciences, Kashan, Iran.

Funding

No funding has been received.

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Authors and Affiliations

  1. Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran

    Mansooreh Samimi & Adeleh Dadkhah

  2. Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran

    Hamed Haddad Kashani & Elahe Seyed Hosseini

  3. Science Faculty, Islamic Azad University, Central Branch, Tehran, Iran

    Maryam Tajabadi-Ebrahimi

  4. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran

    Zatollah Asemi

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  1. Mansooreh Samimi
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  2. Adeleh Dadkhah
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  5. Elahe Seyed Hosseini
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Contributions

ZA contributed in the conception, design, statistical analysis, and drafting of the manuscript. MS, AD, HH-K, ESH, and MT-E contributed in the data collection and manuscript drafting. Z.A. supervised the study.

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Correspondence to Zatollah Asemi.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments.

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Samimi, M., Dadkhah, A., Haddad Kashani, H. et al. The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial. Probiotics & Antimicro. Prot. 11, 1355–1361 (2019). https://doi.org/10.1007/s12602-018-9405-z

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