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

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

Status: Completed

Conditions: Insulin Resistance; Polycystic Ovary Syndrome

Treatments: Behavioral: Time restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06031753

AYUSOP22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

TRE

Experimental group

Description:

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.

Treatment:

Behavioral: Time restricted eating

TRE-HT

Experimental group

Description:

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.

Treatment:

Behavioral: Time restricted eating

HT

No Intervention group

Description:

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.