Skip to main content
OpenTrials
Completed

NCT Number: NCT06031753

Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment

The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.

Completed

Looking for future studies?

Notify Me

Key information

About this study

After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle.

Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose.

Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction.

After data collection, statistical analyses was done to determine the effect of the different approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 20 - 35 years
  • Mild to moderate exercise at least 4 times per week
  • Body Mass Index (BMI) of 20-24.9
  • Diagnosis of PCOS by Rotterdam criteria
  • Type of oral contraceptives: combined (estrogens and progestins) in group 1 and 2.
  • PCOS Phenotype A, B, C
  • nulliparity
  • Signed informed consent letter

Exclusion criteria

  • Menopause or perimenopause
  • Night work shifts
  • Phenotype D (without hyperandrogenism)
  • Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic syndrome, neoplasms, autoimmune diseases.
  • Intake of medications on a regular basis, not including oral contraceptives for group 1 and 2.

Treatment and study plan

Time restricted eating

Behavioral

Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study.

Other names: time restricted eating with hormonal treatment

Primary outcomes

  1. PCOS Rotterdam criteria

    Time frame: 3 months

    Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.

Secondary outcomes

  1. Insulin resistance (IR)

    Time frame: 3 months

    HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance

Sponsors and collaborators

Lead sponsor

Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento

Other

Collaborators

  • Centro Medico ABC

Registry information

Official study title

Time-restricted Eating as a Novel Approach to PCOS Remission, Compared to Guideline's Standard Hormonal Treatment.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.