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

September 4, 2023 updated by: Isabela von Damm Longoria, Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 05300
        • Centro Médico ABC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRE
Only time restricted eating was carried on by this arm, having the first meal of the day at 12:00hrs and last meal of the day at 18:00hrs. No other medication was allowed during the study for this group.
Behavioral: Time restricted eating
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
Experimental: TRE-HT
They carried on Time Restricted eating, in combination with the oral contraceptives used for the standard hormonal treatment. First meal of the day at 12:00hrs and last meal of the day at 18:00hrs. Other than oral contraceptives, no medication was allowed during the 3 months of the study.
Behavioral: Time restricted eating
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
No Intervention: HT
No time restricted eating was practiced by this group, only oral contraceptives were taken, serving as the control group by having the standard hormonal treatment. No modification to their daily habits and routine was made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCOS Rotterdam criteria
Time Frame: 3 months
Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance (IR)
Time Frame: 3 months
HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Centro Medico ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Actual)

November 27, 2021

Study Completion (Actual)

October 11, 2022

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AYUSOP22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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