Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Oct 25;24(1):690.
doi: 10.1186/s13063-023-07691-5.

The effects of intermittent fasting diet alone or in combination with probiotic supplementation in comparison with calorie-restricted diet on metabolic and hormonal profile in patients with polycystic ovary syndrome: study protocol for a randomized clinical trial

Sepide Talebi  1   2 , Sakineh Shab-Bidar  3 , Hamed Mohammadi  1 , Ashraf Moini  4   5   6 , Kurosh Djafarian  7
Affiliations

The effects of intermittent fasting diet alone or in combination with probiotic supplementation in comparison with calorie-restricted diet on metabolic and hormonal profile in patients with polycystic ovary syndrome: study protocol for a randomized clinical trial

Sepide Talebi et al. Trials. .

Abstract

Introduction: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in females characterized by ovulatory dysfunction, hyperandrogenism, and other metabolic disorders. Both intermittent fasting and specific probiotics have been suggested to help improve patients with PCOS through changes in gut microbial composition, circadian clock, and metabolic regulation. Therefore, the present study aims to investigate the effects of intermittent fasting alone or in combination with probiotic supplementation compared to the calorie-restricted (CR) diet on anthropometric measures, metabolic status, inflammation, and oxidative stress in women with PCOS.

Methods: We will carry out a randomized clinical trial for 8 weeks. Participants will be randomly assigned (1:1:1) to one of the three groups: (1) a 14:10 early time-restricted feeding (TRF) diet with probiotic supplementation (n = 30); (2) a 14:10 early TRF diet with placebo supplementation (n = 30); (3) a CR diet (energy-restricted 25% of required calories) with placebo supplementation as a control group (n = 30). The primary outcomes will be changes in body weight and insulin resistance. However, glycemic control, lipid profile, metabolic parameters, sex hormone-binding globulin, dehydroepiandrosterone, anti-Mullerian hormone, free androgen index, hirsutism, acne, antioxidant and oxidant status, inflammation, anthropometric measures, mental health, sleep quality, appetite, eating behavior, food craving, and blood pressure are secondary outcomes. All outcomes of this study will be evaluated in pre- and post-intervention.

Discussion: We hypothesized that 10-h TRE administered alone or in combination with probiotic supplementation to overweight and obese PCOS subjects would lead to weight loss and improved metabolic, hormonal, inflammatory, and antioxidant markers compared to control subjects following a standard 3-meal-per-day CR diet.

Ethical aspects: The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICNE.REC.1401.425).

Trial registration: Iranian Registry of Clinical Trials IRCT20121110011421N5. Registered on 3 October 2022.

Keywords: Intermittent fasting; Polycystic ovary syndrome; Probiotics.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Summary of the patient flow diagram. TRF, time-restricted feeding; CR, calorie restricted
Fig. 2
Fig. 2
SPIRIT diagram of the recommended content for the schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

References

    1. Skiba MA, Islam RM, Bell RJ, Davis SR. Understanding variation in prevalence estimates of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2018;24(6):694–709. doi: 10.1093/humupd/dmy022. - DOI - PubMed
    1. Misso M, Boyle J, Norman R, Teede H. Development of evidenced-based guidelines for PCOS and implications for community health. Semin Reprod Med. 2014;32(3):230–240. doi: 10.1055/s-0034-1371095. - DOI - PubMed
    1. Liu J, Wu Q, Hao Y, Jiao M, Wang X, Jiang S, et al. Measuring the global disease burden of polycystic ovary syndrome in 194 countries: Global Burden of Disease Study 2017. Hum Reprod. 2021;36(4):1108–1119. doi: 10.1093/humrep/deaa371. - DOI - PMC - PubMed
    1. Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, et al. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018;110(3):364–379. doi: 10.1016/j.fertnstert.2018.05.004. - DOI - PMC - PubMed
    1. Kazemi M, Hadi A, Pierson RA, Lujan ME, Zello GA, Chilibeck PD. Effects of dietary glycemic index and glycemic load on cardiometabolic and reproductive profiles in women with polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials. Adv Nutr. 2021;12(1):161–178. doi: 10.1093/advances/nmaa092. - DOI - PMC - PubMed

Publication types