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

Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento16 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome Insulin Resistance

Interventions

Time restricted eatingBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centro Médico ABC

Mexico City, Mexico

Outcomes

Primary Outcomes

PCOS Rotterdam criteria

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

Time frame: 3 months

Secondary Outcomes

Insulin resistance (IR)

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

Time frame: 3 months

Data from ClinicalTrials.gov

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