Clinical trial NCT06031753: Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment
Official title: Time-restricted Eating as a Novel Approach to PCOS Remission, Compared to Guideline's Standard Hormonal Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Lead sponsor: Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
Sponsor class: OTHER
Collaborators: name: Centro Medico ABC
First posted: 2023-09-11
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PCOS Rotterdam criteria
timeFrame: 3 months
Secondary outcomes:
measure: Insulin resistance (IR)
timeFrame: 3 months
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Centro Médico ABC
Study officials:
References: