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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031753
• Other study ID #: AYUSOP22
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: October 11, 2022

Study information

• Verified date: September 2023
• Source: Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 11, 2022
• Est. primary completion date: November 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Mexico	Centro Médico ABC	Mexico city

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento	Centro Medico ABC

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCOS Rotterdam criteria	Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.	3 months
Secondary	Insulin resistance (IR)	HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance	3 months