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

Not Applicable

Completed

• Conditions: Insulin Resistance; Polycystic Ovary Syndrome
• Interventions: Behavioral: Time restricted eating

• Registration Number: NCT06031753
• Lead Sponsor: Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento

Brief Summary

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.

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 Timeline

• Study Start: 2021-06-03
• Primary Completion: 2021-11-27
• Study Completion: 2022-10-11
• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRE	Time restricted eating	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.
TRE-HT	Time restricted eating	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.

Primary Outcome Measures

Name	Time	Method
PCOS Rotterdam criteria	3 months	Ovary volume \>9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.

Secondary Outcome Measures

Name	Time	Method
Insulin resistance (IR)	3 months	HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance

Trial Locations

Locations (1)

Centro Médico ABC; 🇲🇽 Mexico city, Mexico